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EARTH SOURCED Antioxidant-Enriched Natural Moisturizer is a sheer yet surprisingly hydrating moisturizer that does natural right! Designed for all skin types, it moisturizes and supplies skin with plant-based antioxidants along with skin-restoring and replenishing ingredients.
Best of all, fans of natural skincare products finally have a moisturizer whose ingredients soothe, rather than provoke, sensitivity. Instead of excess fragrance and problematic essential oils, your skin gets only gentle (yet effective) ingredients in this 98% naturally-derived formula.
(based on 14 reviews)
Ratings Distribution
5 Stars
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of respondents would recommend this to a friend.
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Most Liked Positive Review
HG Face cream, night or day
I have slightly oily skin, and very oily in summer. This is the most perfect moisturizer I have ever used, and I have used A LOT of them! Lovely consistency, thick but...Read complete review
I have slightly oily skin, and very oily in summer. This is the most perfect moisturizer I have ever used, and I have used A LOT of them! Lovely consistency, thick but lightweight at the same time. Feels great on and I feel good knowing I am getting moisture, antioxidants, cell communicating ingredients, all in one lotion. It slides on beautifully without feeling greasy. Never breaks out my skin. I am IN LOVE with this stuff!
Most Liked Negative Review
Not good undermakeup....bring back hydralight
I liked that this was light, however anytime I put my foundation on top, it would ball up. This is after I applied the moisturizer to a clean face. Very slight burn and...Read complete review
I liked that this was light, however anytime I put my foundation on top, it would ball up. This is after I applied the moisturizer to a clean face. Very slight burn and makes my skin slightly pink. I am so sad the hydralight moisturizer is gone. It was light, smelt like cucumbers, and was perfect under makeup. Handful of my friends are sad too, because upon my recommendations they had purchased hydralight doe under their makeup. This doesn't do the job well, sorry Paula, good ingredients though. Further, the hydralight was amazing for someone like me who is allergic to sunscreen---even the physical sunblocks break me out, I am not sure why.The option to buy moisturizer without sunscreen on your site is getting less and less available for me ( I have to use my sunscreen in power form, with raspberry oil--as it contains spf)
Reviewed by 14 customers
Displaying reviews 1-10
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By Rlav
from Alberta, Canada
About Me Beauty Expert
Comments about Paula's Choice Skincare EARTH SOURCED Antioxidant-Enriched Natural Moisturizer:
Bottom Line No, I would not recommend this to a friend
Beautypedia Team Response:Hi there! We're sorry this didn't work for you. Be sure to e-mail the Paula's Choice Client Services department and they can assist with a refund or exchange if needed. :)
Was this review helpful? Yes / No
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NOT worth the money
By Zamfira
from Cluj, Romania, Europe
About Me Consumer
I was looking for a minimalist, natural moisturizer and I got a cream that doesn't moisturize and makes my face feel dry after applying it. It almost feels like it squeezes my complexion...
Beautypedia Team Response:Hello there! Thanks for sharing your experience. We're sorry it didn't work for you. Make sure to e-mail the Paula's Choice Customer Service team directly and they can help with a refund or exchange if needed. :)
(0 of 1 customers found this review helpful)
By Erica
from Carlsbad, CA
About Me Brand Buyer
Doesn't cause acne, which is good, but not good for dry skin, not moisturizing enough!
Needs to be richer
By EMA
from Texas
I have dry skin but not so dry that it flakes and this moisturizer was not rich enough for me, it almost feels like it dries out my skin more. I was disappointed because I do prefer more natural products but this just doesn't cut it for someone with dry skin.
Beautypedia Team Response:Hello there! Thank you for sharing your feedback. We're sorry you didn't love this! Make sure to e-mail the Paula's Choice Customer Care team directly + they can assist you with a refund or exchange if needed!
Threw it away
By Jocasta
from Arizona
I tried this moisturizer because it had excellent reviews from both the experts and customers. Right out of the gate I had to perform surgery on the opening, which was plugged. I use a sunscreen that I like a lot (Coola) so I didn't want a moisturizer with sunscreen as well (spf is not additive). This moisturizer made my skin feel very very tight, as if I had washed my face and used nothing on it at all. Another layer just made my face feel tacky and a bit waxy. I know others have had great experiences, but I hated this stuff so much that I threw it away after using it, and hoping it would improve, for a few weeks. I can't remember when I last trashed a skincare item, but this one was that bad for me.
Beautypedia Team Response:Hello there! Thank you for sharing your experience. We're sorry this didn't work for you! Be sure to e-mail Paula's Choice's Customer Care team as they'd want to hear your feedback as well!
Would not buy again
By Ren
from WA
Would not recommend. Very drying.
(6 of 8 customers found this review helpful)
Do not use for acne prone skin!!!
By Naomi P.
from undisclosed
I really wanted to love this stuff. So creamy, highly moisturizing, and even smells nice. But the Cocoa butter-based formula is a nightmare on my cystic acne and whiteheads. Great for neck/under-eye area when I want to treat myself, but oily/acne skin... stay away. I'd recommend this to anyone with super-dry skin though.
Beautypedia Team Response:Greetings, and thank you for leaving such a detailed review! Our staffers with very oily skin (including some with acne-prone) have had great success with this product - we're sorry that you didn't! Cocoa butter can be a great emollient for all skin types (including oily and acne-prone) as it's full of antioxidants and can promote healthy collagen production (source: Gasser P, Lati E, Peno-Mazzarino L, Bouzoud D, Allegaert L, Bernaert H. Cocoa polyphenols and their influence on parameters involved in ex vivo skin restructuring. Int J Cosmet Sci. 2008;30(5):339-45), which is likely why it was included in this formula. Be sure to contact Paula's Choice's customer care team for a refund or exchange! Have a great day! :)
(1 of 2 customers found this review helpful)
All time favorite moisturizer
By Ann B.
I am a skin care junkie and have tried them all. This is my all time favorite. I am fifty-something and have oily skin, not blemish prone, a few wrinkles. This does not ever make me oily. Love it for all year round. The best! I wish it was cheaper for the amount you get. I feel like it is slightly overpriced. I can get on Ebay and purchase Olay Regenerist Products for half the price, so often find myself not using this as often as I would like to.
(5 of 5 customers found this review helpful)
(1 of 1 customers found this review helpful)
Light weight moisturizer
By Lauren
This is a great, non-irritating moisturizer for almost all skin types. I get severely dry skin in the winter so I have to switch during that time. It works well for the other 3 seasons. My favorite part is that I'm not allergic to it, as I am most skin care products.
This innovative formula supplies skin with a powerful combination of antioxidants and skin-replenishing ingredients. EARTH SOURCED formulas are based on a specialized, proprietary technology that truly captures the best of nature fused with science.
Paula's Choice Skincare At-A-Glance
Paula's Choice Skincare was established in 1995 when best-selling beauty author and consumer advocate Paula Begoun (known as The Cosmetics Cop) decided to develop her own products.
As a natural evolution of Paula's personal mission to help consumers find the best products for their skin, the line has grown into an extensive range of skincare and makeup products that are formulated to meet the needs of almost every skin type and skin concern imaginable.
The formulas contain only ingredients that have substantiated, published research showing they are beneficial and effective. Stable packaging is another feature of the brand, using innovative, opaque, and air-tight or air-restrictive components that keep antioxidants and other light- and air-sensitive ingredients from breaking down. The line is also 100% fragrance-free.
Disclosure: Paula Begoun is the creator of Beautypedia and founder of Paula's Choice Skincare products. Reviewing thousands of skincare and makeup products over the past 30 years, both on this site and in her best-selling books, Paula's mission has always been to help consumers find the best products possible for their skin. The Beautypedia Team proudly and unequivocally maintains this commitment. In addition, The Beautypedia Team reviews all products using the same rating standards and criteria, whether it is a Paula's Choice product or another brand.
Why are all Paula's Choice Skincare products rated highly? The Paula's Choice Skincare Team would not launch a product unless it was worthy of a high rating from The Beautypedia Team. Paula and The Beautypedia Team were researching and reviewing products long before Paula's Choice Skincare ever existed and consumers were constantly requesting a skincare brand that met all of Beautypedia's criteria. As a result, The Paula's Choice Skincare Team was created and uses the same research and criteria to formulate Paula's Choice products as The Beautypedia Team uses to review products.
For more information about Paula's Choice, call (800) 831-4088 or visit www.paulaschoice.com.
The Beautypedia and Paula's Choice Research teams have one mission: To help you find the best products for your skin, whether they're from Paula's Choice or another brand. By combining efforts, we're able to share scientific research and remain committed to the highest standards based on our decades of experience objectively reviewing thousands upon thousands of skincare and makeup formularies in all price ranges.
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text:
Neurocrine Biosciences Inc. (NASDAQ:NBIX)
Q3 2010 Earnings Call
October 29, 2010 8:30 AM ET
Kevin Gorman – President and CEO
Tim Coughlin – CFO
Chris O'Brien – Chief Medical Officer
Jane Sorensen – Investor Relations
Ian Somaiya – Piper Jaffray
Larry Smith – DLS Research
Stephen Willey – Stifel Nicolaus
Jason Napodano – Zacks Investment Research
Good day, everyone and welcome to today's program. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session. (Operator Instructions)
It is now my pleasure to turn the conference over to President and CEO, Kevin Gorman. Please go ahead, sir.
Kevin Gorman
Thank you very much and good morning everyone. It's our pleasure to be here this morning to talk with you about our third quarter earnings results and also the progress that the company's been making to date. I'm joined this morning by Tim Coughlin our CFO and Chris O'Brien, our Chief Medical Officer and Jane Sorensen, who will now and before we get started read our Safe Harbor statement, Jane.
Jane Sorensen
Good morning. I want to remind you of Neurocrine's Safe Harbor precautions. Certain statements made in the course of this conference call that state the company's or management's intentions, hopes, beliefs, expectations or predictions of the future are forward-looking statements which are subject to risks and uncertainties.
Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the company's SEC filings including but not limited to the company's annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of these filings may be obtained by visiting the Investor Relations page on the company's website at neurocrine.com.
Any forward-looking statements are made as of today's date and we undertake no obligation to update these forward looking statements to reflect subsequent events or circumstances, Kevin.
Kevin Gorman
Thank you, Jane. So the company looks remarkably different than the last time we spoke from a financial standpoint and also from a scientific standpoint, as we continue to progress our programs forward which Chris will be talking to you about. But first let's get into the financials and Tim will take it from this point.
Tim Coughlin
Okay. Thank you, Kevin and good morning to all. Thank you all for joining us. After the market closed yesterday we released our third quarter earnings. It was another very good quarter for Neurocrine. In short the full impact of our recent collaboration agreements with Abbott and Boehringer Ingelheim is now evidenced in our financial results and because of these two deals our financial position has dramatically improved.
Our net income for third quarter was $3.3 million or $0.6 per share on both the basic and fully diluted earnings per share. This compares to a net loss of $8.2 million or $0.21 per share for the third quarter of last year. Our year-to-date loss is $10.5 million or $0.20 per share compared with 2009 year-to-date loss of $43.1 million or $1.11 per share. The reduction of our net loss is primarily due to the revenue recognized under the two new collaboration agreements, the personal restructuring program that we implemented in the second quarter of last year. And cost control measures across all functions within our company.
Revenue recognized under our collaboration agreement totaled $14.4 million for the third quarter of 2010. $9.2 million of this revenue is realized under the amortization of the up-front licensing fees, the remaining $5.2 million of revenue resulted from reimbursement of internal and external research and development costs.
Research and development expenses as well as G&A expenses were in line with our expectations for the quarter and year today. These expenses are significantly lower than last year's run rate primarily due to the lower personnel related costs and across-the-board reductions in non-clinical related expenses.
In light of our improved financial position, we continue to focus on our cash burn from ongoing operations. If one were to exclude the impact of our two recent partnerships, we again met our targeted burn from operations for the third quarter that was established at the beginning of this year. We reaffirm our year-end guidance of ending the year with over $130 million in cash and investments and receivables from collaborating partners.
We expect to have an aggregate net loss in the range of $8 to $9 million. We expect expenses to be within our guidance, given the beginning of the year $43 to $46 million in total expenses. For those looking for more details around the financial results, we plan to file our 10-Q with the SEC later today. We'd be glad to entertain any financial questions during the Q&A portion of the call, before right now turn I'll turn it back over to Kevin for the balance of the presentation.
Kevin Gorman
Thanks, Tim. As you can see that was very concise but very nice, a good financial situation to be in. As was written in there and as we've spoken with many of you about -- we are now aggressively pursuing our programs with our partners and then VMAT2 and Urocortin by our selves. And we are going to keep moving those programs forward, because we now have the financial wherewithal.
Having said that, we are going to keep a very disciplined approach to our spends and to the size of this company. We don't plan on having any remarkable headcount growth in the foreseeable future. I'm not going to speak to you right now about the progress that we are making with them. But I'm going to leave that to Chris O'Brien. He heads of our Joint Development Committee on the Neurocrine side of the Senior Executive Team on both Abbott and our site to find the strategy of the collaboration. So Chris is going to take you through that and also we had a news just last week where we announced that we are going to be taking VMAT2 into a Phase II clinical trial at the end of this year and Chris will speak a little bit more about that. So Chris?
Chris O'Brien
Thank you, Kevin and good morning. Thanks for joining us on the call. So let's start with -- before we get into elagolix and VMAT2, just a reminder that there is the ongoing activity with our Discovery Research Team continuing to work on a variety of internal targets, with the goal of generating compounds for us to bring into clinic and some very interesting stuff as things emerge we'll keep you apprised.
The elagolix partnership is one that is giving us a lot of satisfaction and stimulation. Our collaboration with Abbott is going very nicely. There's a joint project teams that involves the functional groups from both companies and they are hard at work at the moment, finishing out the design and planning aspects for the Phase II uterine fibroids, a trial which will be carried out, the collaboration between the two companies for an initial Phase II study and this disease state. And the Phase III planning for endometriosis, both of these initiatives planned for starting in the first half of 2011.
The ability to start Phase III obviously depends on reaching consensus with the division, the reproductive in neurologic products at the FDA. And as we've mentioned in the press release for the quarterly earnings, the end of Phase II meeting request was filed in September by Neurocrine and the FDA, Abbott and Neurocrine all work together to find dates that would work with the various schedules and the upcoming holidays. And so now we -- the FDA has offered a date in January to have the end of Phase II meeting. So that will be the basis of our discussions for the Phase III trial designs and the balance of the elagolix development program.
Now that program is now safely in the hands of Abbott. Transfer of the IND was carried out earlier this month and now they are the holders of the IND at the FDA. So that has -- things have really proceeded in a quite orderly fashion since the signing of the agreement with Abbott this past summer. And we have an excellent collaboration relationship with the partnership.
The rest of the supportive activities for elagolix are going to as planned with the carcinogenicity study, the manufacturing activities and the ancillary studies that will be carried out so that the NDA has the full complement of data necessary for filing. So for example, some of the residual drug-to-drug interaction studies and other type Phase I type activities are slated to be completed over the next two years.
The interesting piece of data that will be coming out shortly, as you know we finish the Daisy Petal or 901 study, this was the six-month trial with the placebo-controlled results announced earlier this spring. And the women in the trial finished the full six months of treatment and the additional six weeks of safety follow-up post treatment and the database has been mocked and we are finishing the QC of the data. And we will be announcing the results of that shortly and we look forward to sharing that with everyone. So that's the elagolix program. Nice progress for the team, very hard work by all team members and a very satisfying to see this moving forward.
The VMAT2 program obviously is something that we were excited about and Kevin mentioned that in the press release from a few weeks ago, we had completed the multi-dose, repeated dose Phase I trial in healthy male volunteers. And we were very satisfied to see the consistent safety profile, the drug very well tolerated at the doses we are interested in. And most importantly for us, we saw the key PK profile that we were interested namely the limited variability that the good exposure and the nice long half-life with once a day to support once a day dosing. And the concentration time profile that we think is critical to take into patient population with the hyperkinetic movement disorders.
And so to confirm that we have assembled and filed a clinical trial application with Health Canada for our initial Phase IIa exploratory study in patients with Tardive Dyskinesia. And Health Canada obviously is reviewing that file as we speak. And assuming a favorable review and permission to proceed, we will begin the Phase II study at the end of this year. We have a small trial designed as mentioned it's an exploratory Phase IIa case study, designed to help us understand the dose response that we would see in this population, patients with moderate to severe involuntary movement due to exposure to antipsychotic medication. As many of you know Tardive Dyskinesia prefers to a syndrome like Tardive syndrome or tardy meaning late, effects of exposure to dopamine antagonist, whether that's an antipsychotic medication or even some of the antiemetic medication such as metocolpramide.
We are initially going after the TD population patients with schizophrenia or schizoaffective disorder that have been treated with either typical or atypical antipsychotics. These patients after typically a few months to a few years of exposure develop increasingly disabling involuntary movements often of the mouth, the tongue, the jaw, the Face Musculature but also can involve severe hyperkinetic movement of the trunk, of the limbs. And unfortunately for many of these patients, even if they stop the medication that had started the problem, for many of these individuals their movements may not remit over time even after stopping the offending agent.
Now, for some of these patients particularly those with schizophrenia that remain effective that cannot actually get off their antipsychotic medication and to date there is no approved medication for the treatment of Tardive Dyskinesia. It affects anywhere from 200 to 500,000 patients in the U.S. alone. And so this is an important unmet medical need if you will allow me to use that phrase. So we are very excited about this, we will be looking at three doses of our study drug 98854 in this patient population, in a dose titration fashion. And once we get an indication about the low end of the effective dose range on these doses over a 12 day treatment period, we will then plan on filing the IND with the FDA in the U.S. early next in the first half of next year. And then be able to go into a additional Phase II development activities at that time.
So the clear go-no go decision should be available in the spring after Phase II exploratory study is available, [data readout] and we will proceed accordingly. So that's the VMAT2 program. The other activities as you know we have the Urocortin 2 in clinical development activities outside of the U.S. at the moment. The so-called UNICORN trial being conducted by cardiologists in Christchurch, New Zealand is moving along nicely. The trial, its target is to enroll 50 patients with acute decompensated heart failure and currently approximately 34 subjects have been randomized. And the subpopulation -- there is a sub study within that -- it was like 10 subjects will undergo right heart catheterization. And those 10 subjects have actually been enrolled and studied.
The Data Safety Monitoring Group is happy with how things are going. And we expect to have data midyear next year for the full complement of subjects. We also have the University of Edinburgh in Scotland, conducting a series of small Phase I and Phase II trials that are focused on trying to further flesh out the attributes of the Urocortin 2 from a mechanistic point of view. Looking at ways to better characterize and further characterize the potential applications of Urocortin 2 and the appropriate cardiovascular population.
So for example, some very specialized four hour infusion studies, looking at biomarkers of vascular function and dysfunction following Urocortin 2 infusions are currently being conducted. Dosing is underway in those trials and we should have data from our colleagues in Scotland somewhat time next year as well. So Urocortin 2 moving along well and the Boehringer Ingelheim partnership with our diabetes and development program is also moving along nicely. Again that's the discovery phase research targeting GPR119 and that collaboration is a preclinical on discovery collaboration at the moment.
So I think that we have touched on elagolix, VMAT2, Urocortin 2, GPR119. I should mention also that the 679 development program for the CRF1 antagonist continues as you may recall, we continue to add scientific support to some trials in post-traumatic stress disorder and related phenomenon that our clinical research of Phase II initiatives receiving some support from GSK and Neurocrine and the NIH and research institutes such as Emory University. But those are very long-term collaborations over a period of years. But they continue to be ongoing. So I think, Kevin, I have touched on all the areas and I will turn it back to you.
Kevin Gorman
Thank you. So in the coming few months, what we are going to have actually in the very near future as Chris said we are going to have the data -- the six-month data from the 901 study. That's important data for two reasons. One, it will give us at least an additional hundred patients for safety out of six months. And that should bring our database of women treated over a 1000 I believe so.
Chris O'Brien
Subjects treated over…
Kevin Gorman
To a 1000 -- and as far as women that have been treated for six months it takes them to…
Chris O'Brien
So the total number of patients with endometriosis treated for at least 3 to 6 months is up in the over 650 -- I think it's over 700 now.
Kevin Gorman
So when meeting with the agency in January, we are taking to them a very robust Phase II and Phase I program in studying this drug. The second aspect that's important that we want to see from the Daisy Study is the durability of the response as measured by the endpoints that we have tested in here and development with the FDA and patients. And so that obviously is a very important question that needs to be answered at the six-month time point.
So from what you've heard here from Chris and Tim I think it's very important to point out that with elagolix timelines continuing on track and that drug continuing to perform in the future with the current pipeline that we have now and investing heavily in it and moving it aggressively forward, we have the finances already in place to be able to take this current pipeline all the way through ourselves without raising any money on current timelines to the point where elagolix actually hits the market.
So it's a very comfortable place – actually, I should say not comfortable but it's a much better place to be and then we have for the last several years. But again make no mistake we are going to continue to enhance our pipeline and both internally and externally all the way through and we will be looking for other partnership opportunities at some of these drugs mature. And then as Chris said early next year we are going to have the results from this clinical study with the VMAT2 and that will be very important to us also.
So with that why don't we open it up for questions now?
Question-and-Answer Session
(Operator Instructions) And we'll take our first question from Ian Somaiya with Piper Jaffray. Your line is open.
Ian Somaiya – Piper Jaffray
Thank you. I just had a couple of questions. Just first on the Phase III trials -- have you had any preliminary discussions with the FDA regarding the endpoints? Do we anticipate any changes to the daily questionnaire as you move into the Phase III program?
Kevin Gorman
Thanks. Yeah. We have had -- obviously discussions with the agency and ultimately the final agreement occurs at the end of Phase II meeting. I think there will be no surprises. We will continue to see a division that wants us to do co-primary endpoints with dysmenorrhea and non-menstrual pelvic pain using the daily rating scale. And based on the success of Daisy Petal, I don't think there will be anything any radical changes to that program.
Ian Somaiya – Piper Jaffray
Okay. And as you -- if I guess beyond the regulatory trials that's already planned. Can you talk about trials that will help develop the market and where are some of the obvious challenges of treating second line endometriosis? Is the challenge that you can address through clinical trials or what other efforts are going to be required?
Chris O'Brien
Those are terrific questions. Obviously the amount of information that I can share is a little limited because this is Abbott's program. And obviously fleshing out the data package of elagolix for endometriosis, this includes efforts to meet a broader set of market needs beyond simply regulatory requirements for an NDA. But clearly understanding long-term treatment initiatives that is treatment beyond six months, understanding some populations that might have unique needs, looking at how to address functional outcomes and impact on quality of life, productivity in the workplace, the Pharmacoeconomic arguments -- the data package that needed those are all efforts that are under discussion and planning. But the bottom line is as we've said all along with elagolix, the goal is to get this drug to market as quickly as possible. The initial label is for six months of treatment and nothing has changed from that initiative.
Ian Somaiya – Piper Jaffray
Okay. Just one last question and I'll get back into queue. Just on the financial side -- can you remind us of the cost -- Phase II program that's for elagolix and what your base are to spend there? Just trying to get an idea of how we should model spending moving into 2011.
Kevin Gorman
Okay. So, Ian, I wouldn't use the base Phase II program for elagolix just because of the changes we had in the endpoints. So the way I'll answer your question is, if you to look at the revenue section we have two lines. The first is sponsored research and development. That is related to reimbursement or receive for Abbott from Abbott or other collaborators, rate to expenses we have incurred. It also includes our FT reimbursement.
So the people that spent time in the program that we are able to charge up to collaborators. The second line license fees and milestones I think we've hit a static point on that now and we have a full quarter of both the Abbott and the BI agreements in there as well as the DSP agreement, so I don't see that line migrating much going into the future until we start bleeding through those upfronts. That's essentially the deferred revenue coming through the non-cash line.
The G&A line in Q1 and Q2 we were in the low 3 millions. We pushed up a little bit this quarter, but I expect this to be in the low 3 millions going forward. And then R&D is really going to be dependent upon how much Abbott gives us to work on, but our static numbers I think we've talked to before our base burn this year was at $43 to $46 million in expenses. And I think that if you -- since we've essentially unloaded the cost of the elagolix program that's going to be replaced essentially with VMAT2 to a lesser extent for 2011. So that's why I would kind of look at things going forward.
We'll take our next question from Larry Smith with DLS Research. Your line is open.
Larry Smith – DLS Research
Yea. Kevin, I really agree with you what a difference a year makes.
Kevin Gorman
Thanks, Larry.
Larry Smith – DLS Research
I had two quick questions. One was -- Chris, with the modified numbers or public pinpoint, do you think -- what are the advantages of asking the FDA for an SPA just to make sure that they really are on board with that endpoint? And what are the disadvantages?
Chris O'Brien
That was a good question, Larry. My feeling about FDA is it -- it depends on really two things. One, who is the division that you are working with, which division and how do they view SPA? And the second is how much uncertainty is there about whatever the issue that leads you to want an SPA. In this case we have a very good working relationship with this division. We have excellent communication with them and they been very clear about what they want. And the only issue was back when we went to the modification to the wording -- was could we remove the floor of that that we have seen with the initial scale that the FDA asked us to use.
And we have done that they seem happy and we want to lock that down at the end of Phase II. I can't speak fully for Abbott but the assumption is an SPA, in this day and age only gives you a certain measure of comfort. They are not a guarantee and they add a measure of -- an element of time or delay of getting an SPA process and approved. So if you can achieve that at year end of your Phase II meeting and all parties are satisfied that there is consensus that there are no outstanding contentious issues then SPA really doesn't add much value. Particularly, as I say it's not chiseled and still moving SPA. So while we were initially perhaps interested in SPA to try to accelerate the process of getting to start of Phase III. At this point I'm not sure if it really adds much value. But again that will be up to Abbott and it will depend on how the end of Phase II discussions go.
Kevin Gorman
And the only thing that I would add to that Larry, also is that if you were developing new endpoints somewhat in the vacuum you would probably want SPA but this has been something were to a great extent, we followed the direction of the agency and what they wanted from us in these endpoints. So in that sense I think it has been a very collaborative process with this division.
Larry Smith – DLS Research
Okay. Great. And if I could ask one other question, in looking at [Vidorian, Lancastrian] and Conexa, all of them on very different products from elagolix, but the common trend is that the FDA is really putting more boxes on their list to check. So what do you and many of us certainly I was kind of surprised at the aggressiveness that the FDA took in regards to issues with each of those drugs. Are there any issues like that with elagolix that you feel you have to fully defined in the Phase III trial or are they no hidden issues like carcinogenicity or carcinogenicity in animal models?
Kevin Gorman
I don't know what I don't know. But today we have been very forthcoming about all of the issues. As you know early in the development program the question was could you get pain reduction without bone loss? And we knew that was a hot button for the FDA so we invested very early on in the big Petal Study looking at DEXA scan. We put a lot of money and time in getting that answer.
We also knew that theoretically a small molecule non-peptide GnRH Antagonist might cause problems like the GnRH peptide agonist and that you could get Ovarian hyperstimulation syndrome. And very early on we showed that that didn't occur. And so now we are at the stage with a fairly well characterized Phase II molecule with around 1000 subjects exposed.
We think we have a pretty good hand on the profile of the drug particularly with regards to safety. We've completed virtually all of the preclinical work that will go into the NDA and the hot button that are kind of applied to all programs such as carcinogenicity and the QTC assessments, at the moment are non-issues for elagolix. We don't have a QTC binding effect of this drug and we have not seen any ECT signal. But a proper Thorough QT Study obviously will get done during the -- in parallel with the Phase III studies to simply check that box and round up the data set.
As you know we are well into the middle of the two year carcinogenicity study. I think where month -- 14 or 15 at this point and that study has gone well, but obviously it has to be completed and the histology readout done. But to date no items of concern other than the need to complete the study. So I don't have any secret surprises in my back pocket that I'm concerned about. But this is drug development. This is Phase II. Lots of surprises can happen when you scale up from 1000 subjects to 3000 subjects and complete the (inaudible) study, so we will see how that goes.
Chris O'Brien
And also, Larry, you do bring up -- the agency is putting higher hurdles in front of every drug that they seek regardless of drug class and the way that we handle that and especially with our history, it's just very important to have as much transparency with the agency as humanly possible both ways and have good communication. We think we have that with this division.
But clearly there are cross divisional activities that take place in the FDA and those are coming to the floor starting in the end of phase II meeting. So we will be starting to meet some of those players within the FDA and hopefully, we can keep a good communication with them going also.
Larry Smith – DLS Research
Sounds like you thought about this. Thank you.
Kevin Gorman
Just a little bit
All right. We'll take our next question from Stephen Willey with Stifel Nicolaus. Your line is open
Stephen Willey – Stifel Nicolaus
Hi. Good morning. Thanks for taking the question. Real quickly on VMAT2, just wondering, maybe what some of the historical efficacy endpoints have looked like here? Presumably, there is some kind of scoring or subjective assessment and I'm wondering how validated these assessments are and maybe talk about the length of the running you are going to have prior to moving patients onto drug?
Chris O'Brien
Sure. Steve, thanks. There are established skills that have been around for sometime. The main one that most people are familiar with is something called the abnormal involuntary movements scale or AIMS. And the AIMS scale is a rating scale for the intensity of the hyperkinetic movements by body region. So mouth, face, trunk, limbs and the scoring is done by a trained observer done during a structured neurologic examination. And there are many, many publications on the AIMS out there.
It's been around for a while. It's used across hyperkinetic syndrome. So it's not limited to just Tardive Dyskinesia. It has been used in other involuntary movements but primarily that's where you will see its application. You use the word validated. You know that is validated in the old -- in the traditional sense of has it been used a lot of times and accepted by regulatory authorities as an appropriate endpoint.
And to that extent, you have to say yeah. Then that is validated in a more modern terminology which is has it been constructed as an instrument from the ground up, using modern psychometric scale development techniques? No. The AIMS has been around a long time. It's been used and widely used and is well-established in the literature and as I said, used by regulatory authorities and considered a validated instrument.
But clearly that's part of my program at four VMAT2 as we bring the development program forward. That's part of the discussions that we will have with the FDA at the IND stage and clearly to Kevin's point earlier, having transparency and good communication with the appropriate division at the FDA and with the authorities at the EMA is really critical. There are initiatives to develop other scales for hyperkinetic movements and we are well aware of those.
You may recall, I mean, movement disorder neurologist by training and have actually helped develop the Parkinson's rating instruments, the Huntington's rating instruments in my former life. And so we'll obviously be plugged into this and we'll impose some measures of robust scale activities even with the AIMS.
So for example, we videotaped the structured neurologic exam and then we use the videotapes and have them rated by a blinded central review separately from the investigator, all those kinds of things will be done to make sure that there are no surprises.
Stephen Willey – Stifel Nicolaus
Helpful. Thank you.
We'll take our next question from Jason Napodano with Zacks Investment Research. Your line is open.
Jason Napodano – Zacks Investment Research
Hi guys. Thanks for taking the question. Just a quick question on milestones, what's the next realizable milestone on elagolix with Abbott? Is there -- I'm talking payment. Is there anything for completing end of Phase II or initiation of Phase III?
Chris O'Brien
We can't really discuss those. They'll become evident, very evident as we hit them. Suffice it to say that while we haven't yet given guidance on next year formally, we don't believe -- we believe that are ending cash balance this year will be the same as our ending cash balance next year and that's based on milestone achievements.
Jason Napodano – Zacks Investment Research
Okay. Fair enough. Thank you.
Chris O'Brien
You're welcome.
And we have no further questions at this time.
Kevin Gorman
Well, I want to thank everyone this morning for participating and also thanking everyone that's been on the call for their support of the company over the last several years. We're feeling that we are starting to turn the corner here. We haven't turned it, we are starting to turn the corner here. And we're going to be working diligently towards that. Just to end here, I'm going to be -- we're going to be presenting at the Oppenheimer conference next Tuesday. I believe our talk is at 11 a.m. and at that forum, we'll be webcasting the Q&A section of that more of a fireside chat. So I look forward to having meeting more of you there and having the opportunity to continue this dialogue. Thank you very much.
This is today's teleconference. You may now disconnect and enjoy the rest of your day.
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subset: commoncrawl


text:
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There's always an army of white people to defend their fellow racists.
"A white woman standing on a stage and insinuating that Mexicans or other men of color are rapists, given our history, given that historically when white women made claims, most of the times they were false about black men raping them, somebody ended up hanging from a tree. " — Dr. Stacey Patton, author of The Washington Post, Op-Ed.
The Washington Post, one of our nation's most venerable guardians of free speech took a step in a surprising direction earlier this week, publishing an article by Dr. Stacey Patton and David Leonard that called out comedian Amy Schumer as a racist.
The article likened Schumer's comedy to Donald Trump's politics and accused Schumer of using "dehumanizing language that gives life to an ecosystem of racial fear and violence." The article also accuses Schumer of suggesting "that Mexicans, or other men of color, are natural-born rapists," and says that "while black families are burying their dead, churches are burning, black women church pastors are receiving death threats and the KKK is planning rallies in South Carolina, Schumer is 'playing' with race…and only white people are laughing."
There are some powerful accusations in play here, and the masthead of The Washington Post carries considerable weight. With so many worthy targets creating genuine oppression to choose from, we couldn't help but wonder why the Post would aim its rather sizeable artillery at this particular target, at this particular time? Why comedy and why Schumer?
It was only a few short months ago when the world, and The Washington Post clamored to support the victims at French satire newspaper Charlie Hebdo after their offices were attacked leaving 12 dead. The Washington Post stood up for free expression, publishing a highly controversial and polarizing cover. An editorial by Charles Lane, published by the Post in January said, "it is vitally important that the United States and all other Western democracies rally to their unequivocal defense. If freedom means anything, it means freedom of expression — to include expression that some might find irresponsible, offensive or even blasphemous. In the realm of art and ideas, pretty much nothing is, or should be, sacred, lest we head down the slippery slope to censorship, or self-censorship."
But Amy Schumer's comedic, and even satirical expression isn't being considered important in Patton and Leonard's piece. And the thrust of their article is that there are indeed topics that are sacred and even unacceptable in comedy.
I spoke with The Washington Post's Outlook Deputy Editor Mike Madden about the seeming contradiction. "This is not the opinion of The Washington Post," Madden told me, "this is the opinion of a couple of contributors to The Washington Post." Of course both articles are editorials and newspapers print conflicting editorials all the time. But even op-ed pieces are edited and selected and subject to internal guidelines and even op-ed pieces enjoy the weight of The Washington Post banner– one which has a history of protecting journalistic expression feverishly.
I asked Madden if he knew why the article's author, Dr. Stacey Patton had chosen Amy Schumer as the topic for her article. "I think she pitched this piece because Schumer was in the news, at least in some circles in the news. Probably because of that Guardian piece," he said, and suggested that I talk directly with Dr. Patton. I did.
Dr. Patton said a few things that surprised me. For starters, she said she's not a specialist on comedy or humor. While she does enjoy comedy (she likes George Carlin, Richard Pryor, Martin Lawrence, the Queens of Comedy, and Bill Maher among others), she told me that watching comedy isn't something she gets to do often. In fact, before the 'Schumer issue' came up, she had never seen Amy Schumer perform stand up, and she had never seen Schumer's Comedy Central television show. Even more surprising, she said she didn't watch any of Amy's performances or shows while writing the article, not even as background for the piece. Her judgement was based on what she read, presumably in The Guardian, which had just published an article accusing Schumer of "having a blind spot for race."
The Interrobang; Have you ever watched Amy's television show… in preparation for the article?
Stacey Patton: Nope. Not at all.
The Interrobang: Her stand up set[s]? have you ever watched any of them?
Stacey Patton: Nope. None of them.
Despite seeing the quotes out of context, and without the benefit of knowing anything about Amy's comedy, she was comfortable making judgements about whether Schumer's comedy was or wasn't racist. She also was comfortable deciding whether Schumer's audience was or wasn't racially diverse (she characterizes Amy's following as predominately white), and she was comfortable to conclude that Schumer's comedy breeds racism in others.
I was also surprised to learn that Dr. Patton hadn't "pitched" the article to The Washington Post. She said it wasn't her idea at all, and in fact she initially turned down the story, because, she thought there wasn't much there. Patton said:
"The Outlook editor actually wrote to me last week and asked if I'd be willing to write about this. And I hadn't actually heard about the incident. And you know, I'm not a fan or foe of Amy Schumer. Hadn't really paid attention to her. She's not a comedian whose work I follow so I was not really that familiar with her. And I was still quite frankly reeling from Charleston. Because I was in Charleston three days before the shooting and I was staying two blocks away from the church so, yeah, I was still dealing with a lot of the backlash from my Washington Post piece on that. And so when I kind of looked at some of the coverage on Schumer, I initially thought meh. This woman is joking. You know, myself and a lot of people are still grieving the lives of those people in Charleston.
"But then I thought about Donald Trump's remarks and then the fact that a few days later Dylann Roof stands up in a church and before shooting nine people says, "taking over my country you're raping our women" despite the fact that most of his victims were black women. And then it was Schumer's comments about Mexican men and rapists. And I thought, see, that's when I had to say something."
Patton explained to me that one of her primary concerns here is context. She explained.
"A white woman standing on a stage and insinuating that Mexicans or any other men of color are rapists, is racist. Given our history, given that historically when white women made claims, most of the times they were false about black men raping them, somebody ended up hanging from a tree. We are living in a climate where there is still that very potent fear about interracial sex. So I think context is really important."
Context was a theme that she'd return to again and again throughout our conversation.
I don't doubt that Dr. Patton means well. She's a well respected journalist, and from what I gathered in our conversation, very intelligent. She is concerned about very serious problems faced by people of color in America and the world today, and those problems are real and in need of redress. And without the important context of understanding performed comedy, Schumer's act, and her persona, it might be hard to distinguish Schumer's point of view from a completely different kind of joke– one that is harmful, and derogatory, and holds no benefit to the community at large. Patton described to me concerns about the type of people who "back during the Jim Crow period, while nearly 4,000 black people were lynched in this country, [were] making jokes; they were singing minstrel songs, putting on black face, telling chicken and watermelon and pickaninny jokes." Those types of harmful, racially motivated jokes of course still exist today, and are just as rooted in hate as they ever were. And perhaps Patton is correct that the people who laugh at those types of jokes add to what she calls "this ecosystem of nasty rhetoric."
But that argument ignores that performed comedy that integrates and confronts, and yes even "plays with" race and bias, is not the same as a "chicken and watermelon and pickaninny joke." There is nuance and skill that a performer uses to communicate that they are not advocating racism and intolerance– on the contrary, they believe in inclusion and tolerance. Laughing at our own shortcomings, biases and history of intolerance can advance harmony in a way that lecturing, and even legislating cannot. When we, as an audience can laugh at stereotypes… we don't reinforce them, we expose them. And it's all to the benefit of society.
Patton has made presumptions regarding the racial composition of Schumer's audience, and she has also made presumptions about the effect Schumer's comedy has on her audience. Those presumptions are made without any real information, and seem to be based on nothing more than speculation and her own social media following.
"Based on the images that I've seen, photos of her– again, I have not watched any of her videos but if I look and I see a predominantly white audience that tells me something right there. And based on what I'm seeing on social media– and I have a huge social media audience myself, most of the black people that are commenting– actually all of them that I'm seeing– have been reacting very negatively to her. So that tells me that she's not very popular among people of color. The vast majority of people of color who watch comedy don't watch her. They watch the Queens of Comedy or the Kings of Comedy. The reality is that the comedy world is segregated. Period. Yes you have a few comics who might cross over a little bit, but it's largely segregated. Most black people that I know who watch comedy don't watch Amy Schumer. Go up and down my time line and time lines of other friends. They're like, never heard of her."
But all you would need to do is attend any of Schumer's performances in New York City to see otherwise, or browse social media while her show is airing on Comedy Central. You will find a multitude of cultures, colors, languages, genders and countries represented. And by and large, they "get the joke" and they know the difference between harmful jokes and comedy.
I asked Dr. Patton how she would feel to find out that people of color laugh at these jokes. She told me that there have always been all kinds of black people, including those who are self hating, or disagree with affirmative action, or were overseers on the plantations. She added, "people of color are not monolithic folks. We have people who are raised in different kinds of families and communities and have different political persuasions and tastes when it comes to humor. So of course you're going to find people of color who think that's funny. And generally the vast majority of black folks, when we come across people like that we call em out, and say 'okay you know, whats wrong with you? ' So we know that there are those among us who don't have the same kind of sensitivity when it comes to issues of race." Perhaps Dr. Patton doesn't trust that there are audiences who understand subtlety and satire, and can differentiate between hateful speech and comedy. But to do that she would first need to listen to more than just a quote, or a clip. Schumer's comedy is full of instances where she's pushing social boundaries in the best possible directions. You can read dozens of articles talking about the gender biases she exposes through her comedy, and taking on issues of body image, rape culture, sexual identity, and other societal issues that matter.
So why Amy, why now? It's certainly not because Schumer has gone too far over the line as compared to other performers. She's not known for racial sets. It seems that Schumer was targeted because she's getting a lot of press with the release of her upcoming movie Trainwreck, and people are interested in her, so generating controversy is profitable. Perhaps she just seemed like an easy target, as a woman. Or maybe there are those who are uncomfortable with the gender boundaries she addresses and the abundance of press and praise she has received in the last two months.
But The Washington Post name carries weight, certainly far more weight than Amy Schumer, who is just beginning to see her career grow. To suggest that Schumer needs to be more responsible with her comedy with one hand, while casually branding a young artist with powerful words like Racism with the other, seems to have its own irresponsibility not only toward Schumer, but toward other young artists trying to decide what they can and cannot talk about. And to tie an artist– particularly an artist who is herself breaking down long standing barriers– in with murder, the Klan and the burning of black churches is something that should not be done lightly. There are serious consequences to such statements.
The Post article cautions against using the "its just a joke" mentality, as do we, because it's not "just a joke." Comedy is a socially and culturally important art form. Comedy is an important form of communication that at its highest level is as critical to our social progression as journalism, and while it may be understandable that Dr. Patton and her writing partner might not appreciate that, it's startling to see that The Washington Post would be as cavalier. Dr. Patton states in her article that "motivation is not the issue. what matters is the cost/consequence of these jokes." But what is the cost and consequence of accusing someone of racism without context, background, or any real information?
There's always an army of white people to defend their fellow racists.
@DmitriKhitrovo Hai and Welcome!
She's not funny. Very few women are.
Patton is a retarded cunt. Fact is, she's the fucking racist. She doesn't think "people of color" can understand what comedy is. This dumb cunt is useless.
The best part was when Patton suggests that people of color who laugh at "racist" jokes must be self-hating, and that has something to do with how some blacks were overseers on plantations....LMAO.
Meh. A leftist "intellectuals" are using the same simple-minded attacks that have become the worst of cliches. The only new, interesting aspect is that theynarendirecting gheir nonsense at a fellow leftist.
" I'm a specialist on racist language". WTF does that mean? Is there a degree in that now?
"It seems that Schumer was targeted because she's getting a lot of press with the release of her upcoming movie Trainwreck, and people are interested in her, so generating controversy is profitable"
you could have just this, it is pretty damn spot on and all anyone needs to know about all this bs.
Next time please avoid the jab at women. Women aren't "easy targets" you flaming sexist.
@YannG Come on dude everyone knows only homosexuals can be described as flaming
So it was a pre-determined hit piece that the author allowed herself to get talked into writing, although she had no concept of what the story was. Now she's trying to excuse herself by saying it was right after Charleston, and she really felt like hitting someone.
@section77 Pretty much. I'd say something about egg on some faces, but that'd probably be misconstrued as racist somehow.
Moving past the specifics of this particular hit job, @DrStaceyPatton is right that context matters. Comedy is art, and art is more than what the artist intends people to think of it. Since Amy Schumer became known to the masses this past month I've been thinking back to Dave Chapelle's self-imposed exile from the limelight. It'd be hard not to. His TV Show was hilarious, biting, and an increasing hit, but he shut it down not because *he* was racist, but because he sensed an increasing fraction of his audience was. They were laughing for the wrong reasons, and his comedy (or his demography) gave them cover to do so.
Like a lot of folks, I've seen Amy's show, but not much of her stand-up routines. But I like the stand-up format, and I could imagine her doing a stupid-white-girl act really well. I'd laugh. I'd be in on the joke. Is it okay that some of her audience might not? Maybe. Probably. I don't see her race-baiting her away into national attention, so maybe the joke's on the guys in the club that think she actually hates Mexicans. Or maybe the joke's on me because I might be more offended if she'd said something crass about black men instead. Or maybe the joke's still on The Washington Post for showing off how lame journalism's become.
Maybe it's all of those things. The funny thing about art is that it's rarely just one thing or another.
Falsely claiming racism where there is none, is the equivalent of crying wolf.
@MikeLemmon Don't forget, a flag is responsible for shooting people in SC.
@MikeLemmon The left has cried "racism" so much that the word doesn't mean anything anymore.
This "Doctor" (of what, Bullshittology?) seems rather proud of her ignorance. If it wasn't for nit, she wouldn't have any wit at all.
Check out photon belts and sew where earth is at....come on now evolve and be free. Don't let it get to you. Race comments are just moot. Outdated!!!!!
Hmm...maybe before such a date monsters didn't care about race culture class or creed. They just ate and did all kinds of things to us to them selves and wreaked all kinds of havoc and just really were true man eaters. But um its looking like earth is going home bent broke and busted and we're just going home. Fabulous clean and getting happy.
Wow, the navel gazing while the house is burning of the American public is really sad. As if some universal epiphany is either possible or the least bit beneficial.
The problem of "race" is an artificially manufactured one solely intended to distract people from the real crime of stealing your liberty. The current government irrespective of party affiliation is only interested in constant expansion of reach and authority over you. Rather than being a useful tool pulled out occasionally for limited use in limited contexts it actually impacts every waking moment of your life. And you folks want to accept race as an issue to absolve yourself from confronting what you know in your heart is the problem: the politicians and special interests. The laugh is on you.
@Gatortrapper Let me be as clear as I can. I love government! Big government is the greatest thing that ever happened to this nation. The government, at it biggest, following world war 2, built for us, the greatest national infrastructure the world has ever seen. Your version of liberty is complete bullshit and simply doesn't align with 21st century progress. Your version of liberty is available to you, just pack up and move your ridiculous self to Somalia, Ethiopia or Yemen, where there very kind of liberty that you desire is awaiting you, as is starvation, piracy, rape, genocide and disease. Send us a post card will ya? P.S. ... You are incapable of reasoned thought, you might want to take advantage of the education system that Big Government has made available to you.
@Driverdude Hi and Welcome!
Ad hominem personal attacks on me for opining that the issue of race is a deliberate distraction from more fundamental threats speaks to YOUR lack of capacity not mine. Obviously I hit a raw nerve with my observation for it to generate such a personal attack.
What's funny is that you struggle to understand the very basic concept that the vast resource created by my preferred size of government is what sustained yours. But now having plundered the national fisc to the tune of $18 trillion in real debt and upwards of $100 trillion of unfunded commitments your model has bankrupted the nation. Typical of those lacking self awareness or a keen understanding of the long game you take umbrage at anyone who suggests the fault lies with your big government model.
Let's toss some numbers on the table duffus and see if you can keep up: historic rate of interest on national debt 5-6% versus zero bound Fed policy since 2009 leading to 2% rate on national debt at present or 1/3 of historic average. Can you keep up? FY2014 we borrowed $483 billion while paying $430 billion in interest at that low 2% rate. Any dots connecting for you yet? Didn't think so...
There are 2 principal issues with that... first the fact that you're effectively taking cash advances on Visa to pay the interest ONLY on the MasterCard and adding to the principal debt accumulation, not retiring it. Second, the rate of interest will return to normal from 2% to 4-6% range at which time, as the short term instruments mature and paid they will be replaced with those with the higher rates. Can you keep up with this?... I doubt it but for others I'll finish... The result will be an escalation in the debt service component that easily doubles or triples which would push that $430 billion to $860 or $1,290 billion. And having ravaged the taxpayer you'll be having to cut your precious programs to pay the debt service or default like Greece or Argentina. What disgusts me is idiots like you who think you know so much and arrogantly demand we bend to you deluded thinking. You waste precious oxygen in the world with your every breath.
@Gatortrapper He was right to criticize you. I didn't take much for you to launch into name calling and saying "can you keep up?", etc. Your last sentence is particularly illuminating. Your point would have been better made by not responding at all.
@Gatortrapper Also, race and racism predate 17th Amendment by at least a few thousand years.
@Driverdude Somalia: the country so libertarian, they banned Christmas.
You're an idiot.
@kabulykos Dude the 17th Amendment provided for popular election of Senators. And the historical fact of race being an issue of divisiveness for some does not mean that it was or is an issue in the United States today. It is a manufactured issue in that whatever minimal life support that it was on has been removed and instead it's been brought to life as a Frankenstein monster to be used to distract from the real existential issues that the political elite don't want people inquiring about. That you folks can't get that merely is proof that their sleight of hand effort has been successful.
@DennisHastings1 <=needs help understanding definition of "sarcasm" as he equates it with a personal attack on character. Can someone in Dennis' hometown get him a dictionary?
I don't suffer fools lightly. You seem to be interviewing for one of the positions in the duffus academy too. You want to complain about the quality of the syntax and tone of a message conveying a serious message about the unfolding financial ruin of the nation proffered as a rebuttal to someone embracing an ever increasing government? Boy this country is totally screwed if you're representative of your circles o influence.
If the shoe fits where it. Apparently it's your size too.
Your point being that racial tension has been an issue from dawn of time no doubt.
@Gatortrapper @kabulykos If you don't think racism is an issue in America today, then you must be blind, deaf and dumb. If you know any people of color, ask them in private if that's the case. If you don't know any people of color or are afraid to ask, then that will tell you if you are sheltered and out of touch. If you prefer to assume you know already, then you can't handle a test to your belief and prefer to live in blissful ignorance, which is fine, but understand, that's what it is.
What about following the first rule of writing? Write what you know. Research, it's not just a good idea.
@Siccerson Careful, WaPo might ask you to write an Op Ed.
@DrStaceyPatton Would you say that the only solution to such damaging humor is to forbid all comedians from performing racial humor? Or should only white comedians stop because, after all, only white people can be racists.
@YotaruVegeta @DrStaceyPatton Well said, I simply don't believe she is being as altruistic as many are saying and she is trying to claim in not so many words hence never having even been to her show to witness the audience or even watch the tv show to inform herself.
This is why liberalism/progressiveness is out of control, they were sorely needed and maybe in some cases still are but some of the demonizing going on now is what happened to many of these people/groups in the past.
@YotaruVegeta @DrStaceyPatton That's a very complex, realistic question Yotaru. "Doctor" Patton isn't able to handle those.
@GaryMccollom @YotaruVegeta @DrStaceyPatton It's all out of control. I wont let any party or political philosophy get a pass. I see the news of all sorts behaving badly.
Let's actually watch Amy Schumer do race jokes, shall we?
If you take that as not being satire, you need your head examined.
Then you'll love sharing this one that I heard today from a good friend who probably qualifies as a red neck: "Why is so hard to solve "red neck" crimes? Because their DNA is indistinguishable and dental records are useless."
I'm a progressive, liberal, leftist, and I personally find her 'racist' humor funny. I still like to think that most liberals find this type of racial humor funny and it's a vocal minority. But then again, I've been called out as racist several times by liberals for using this type of humor. But I have to say, if I hear someone who's racist say these things, it's not quite so funny.
@Gatortrapper really
Oh, but we're all supposed to laugh when Jamie Foxx says it was awesome that he got to "kill a bunch of white people" during his SNL monologue? Comedians push boundries. Obviously if you've got a stick up your ass, comedy is not for you. I've heard worse on Family Guy. Quit getting offended over everything, America. Stop generalizing white people as a bunch of slave-owning rapists, too. Every race in history has ugliness in their past. EVERY race. You want to cry about slavery? Look up Irish Slavery. My ancestors were treated like garbage too. Am holding it against people that foamy actually commit the act? Nope. So, sit the **** down.
there are people in the world who are dying and starving and this is what you're angry about? Look at the world around you..
Weren't there TWO writers to the article? Focusing on one of the authors while ignoring the other seems like being guilty of the same thing this writer is harping about. Also, the Washington Post writer is not the only person who has accused Miss Piggy for being a racist.
@gasfarty2 The other one was smart enough to not do an interview
@gasfarty2 Hi and Welcome!!!!!
@gasfarty2 Oh, "Miss Piggy" because she's Jewish. Haha. I get it.
i've never seen Amy perform, does this make me black
@White Guy Only if you claim she's a racist.
The writer calling Amy a Racist seems like a good speaker, If u want to book him to do a speech you can contact him via email: email@example.com
@MichaelBrian1 Hi and Welcome!!!!!


text:
Brouillet v. Holder et al
Petitioner: Eybar Brouillet
Respondent: Jeh C. Johnson, Eric H. Holder, Jr. and United States Immigration and Customs Enforcement
Case Number: 3:2014cv00004
Filed: January 7, 2014
Court: Alaska District Court
Office: Anchorage Office
County: Anchorage
Presiding Judge: Timothy M. Burgess
Nature of Suit: Other
Cause of Action: 28:1361
Jury Demanded By: None
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text:
Signs point to solid 2012 duck season
MARSHALL – As the Department of Natural Resources continues its recruitment work to boost hunter numbers, it spread a bit of good news recently with what it is preliminarily calling a strong 2012 waterfowl season.
The DNR said an earlier season opener, regulation changes that created more opportunities and near-ideal weather conditions all played a factor in making the 2012 season a successful one.
Although official 2012 duck harvest numbers are not out yet, an increase in harvest is expected going by hunter bag checks on opening day and reports from regional waterfowl managers. Harvest counts in recent years have been around 650,000 ducks, with mallards coming out on top, followed by wood ducks, blue-winged teal, ring-necked ducks and green-winged teal.
"Success was good on opening weekend," said DNR Waterfowl Specialist Steve Cordts. "Generally, in a lot of places we saw three ducks per hunter, per day; in some cases it was over four. Anything over three is good."
2012 was the second consecutive year the opener fell in September. Between 2005-2010, the state opened the season on the Saturday nearest Oct. 1, which at times put the opener in October.
"That early-season success was predominantly blue-winged teal and wood ducks, which is why we opened the season earlier," Cordts said. "Almost half the duck harvest occurs the first two weekends of the season – it really makes or breaks the duck season. If we're good early, then the season is generally pretty good."
An increase in bag limits on wood ducks from two to three also made a positive impact, Cordts said.
The DNR also added a third duck zone in southern Minnesota and used different splits, or closed periods, to provide some later hunting in that part of the state. The DNR is also considering more changes, including allowing Canada geese hunting in August, changing the early goose season bag limit and allowing open water duck hunting on a small number of lakes.
Cordts said the success on opening weekend came despite it being unseasonably cold those days. But warmer days followed and the opening-weekend success continued during the following weeks. And the dry conditions, a bane for farmers in 2012, actually helped duck hunters who were able to access lakes.
"Access was fairly hard to some hunters, but in a lot of places in southern Minnesota, if you found water, there were ducks on it," said Cordts. "A lot of shallow lakes down in your part of the state will benefit if the water stays low."
Cordts said the low water levels, while good in some ways, can limit the breeding population, and might play a factor this fall if dry conditions persist across southern Minnesota.
"We'll see what Mother Nature brings us this spring," he said. "High water is generally not a good thing for shallow lakes, but it attracts breeding ducks."
Duck hunters could be facing some other challenges in the future, too, if loss of habitat such as Conservation Reserve Program lands that have expired and have been converted into farm production land, continues to increase.
"CRP loss is massive as far as how many acres have come out," Cordts said. "I think we peaked at about 1.8 million acres five, six years ago, and we've lost about 400,000 acres. Right now, it's just not financially viable for those producers to keep their land in CRP; they make more by farming it."


text:
|Publication number
|Publication type
|Application number
|Publication date
|Nov 10, 2009
|Filing date
|Dec 6, 2005
|Priority date
|Dec 6, 2005
|Fee status
|Also published as
|Publication number
|Masaaki Higashitani
|Original Assignee
|Sandisk Corporation
|Export Citation
|BiBTeX, EndNote, RefMan
|Patent Citations (43), Non-Patent Citations (10), Referenced by (4), Classifications (13), Legal Events (4)
|External Links: USPTO, USPTO Assignment, Espacenet
This application is related to U.S. patent application Ser. No. 11/296,235, entitled, "Low Resistance Void-Free Contacts," filed on the same day as the present application.
This invention relates to flash memory arrays and in particular to the structures of flash memory arrays and methods of forming them.
There are many commercially successful nonvolatile memory products being used today, particularly in the form of small form factor cards, which use an array of flash EEPROM (Electrically Erasable and Programmable Read Only Memory) cells. Such cards may be interfaced with a host, for example, by removably inserting a card into a card slot in a host. Some of the commercially available cards are CompactFlash™ (CF) cards, MultiMedia cards (MMC), Secure Digital (SD) cards, Smart Media cards, personnel tags (P-Tag) and Memory Stick cards. Hosts include personal computers, notebook computers, personal digital assistants (PDAs), various data communication devices, digital cameras, cellular telephones, portable audio players, automobile sound systems, and similar types of equipment. In an alternative arrangement to the separate card and host described above, in some examples a memory system is permanently connected to a host providing an embedded memory that is dedicated to the host.
Two general memory cell array architectures have found commercial application, NOR and NAND. In a typical NOR array, memory cells are connected between adjacent bit line source and drain diffusions that extend in a column direction with control gates connected to word lines extending along rows of cells. A memory cell includes at least one storage element positioned over at least a portion of the cell channel region between the source and drain. A programmed level of charge on the storage elements thus controls an operating characteristic of the cells, which can then be read by applying appropriate voltages to the addressed memory cells. Examples of such cells, their uses in memory systems and methods of manufacturing them are given in the following U.S. Pat. Nos. 5,070,032; 5,095,344; 5,313,421; 5,315,541; 5,343,063; 5,661,053 and 6,222,762. These patents, along with all other patents, patent applications and other publications referred to in this application are hereby incorporated by reference in their entirety for all purposes.
In a NAND array series strings of more than two memory cells, such as 16 or 32, are connected along with one or more select transistors between individual bit lines and a reference potential to form columns of cells. Word lines extend across cells within a large number of these columns. An individual cell within a column is read and verified during programming by causing the remaining cells in the string to be turned on hard so that the current flowing through a string is dependent upon the level of charge stored in the addressed cell. An example of a NAND architecture array and its operation as part of a memory system is found in the following U.S. Pat. Nos. 5,570,315; 5,774,397; 6,046,935 and 6,522,580. NAND memory devices have been found to be particularly suitable for mass storage applications such as those using removable memory cards.
The charge storage elements of current flash EEPROM arrays, as discussed in the foregoing referenced patents, are most commonly electrically conductive floating gates, typically formed from conductively doped polysilicon material. An alternate type of memory cell useful in flash EEPROM systems utilizes a non-conductive dielectric material in place of the conductive floating gate to store charge in a non-volatile manner. A triple layer dielectric formed of silicon dioxide, silicon nitride and silicon oxide (ONO) is sandwiched between a conductive control gate and a surface of a semi-conductive substrate above the memory cell channel. The cell is programmed by injecting electrons from the cell channel into the nitride, where they are trapped and stored in a limited region, and erased by injecting hot holes into the nitride. Several specific cell structures and arrays employing dielectric storage elements are described in U.S. Pat. No. 6,925,007.
As in most integrated circuit applications, the pressure to shrink the silicon substrate area required to implement some integrated circuit function also exists with flash EEPROM systems. It is continually desired to increase the amount of digital data that can be stored in a given area of a silicon substrate, in order to increase the storage capacity of a given size memory card and other types of packages, or to both increase capacity and decrease size. One way to increase the storage density of data is to store more than one bit of data per memory cell. This is accomplished by dividing a window of a floating gate charge level voltage range into more than two states. The use of four such states allows each cell to store two bits of data, eight states stores three bits of data per cell, and so on. A multiple state flash EEPROM structure and operation is described in U.S. Pat. Nos. 5,043,940 and 5,172,338, which patents are incorporated herein by this reference.
Increased data density can also be achieved by reducing the physical size of the memory cells and/or the overall array. Shrinking the size of integrated circuits is commonly performed for all types of circuits as processing techniques improve over time to permit implementing smaller feature sizes. But there are usually limits of how far a given circuit layout can be shrunk in this manner, since there is often at least one feature that is limited as to how much it can be shrunk. When this happens, designers will turn to a new or different layout or architecture of the circuit being implemented in order to reduce the amount of silicon area required to perform its functions. The shrinking of the above-described flash EEPROM integrated circuit systems can reach such limits.
One way to form small cells is to use a self-aligned Shallow Trench Isolation (STI) technique. This uses STI structures to isolate adjacent strings of floating gate cells such as those of NAND type memory arrays. According to this technique, a gate dielectric (tunnel dielectric) layer and floating gate polysilicon layer are formed first. Next, STI structures are formed by etching the gate dielectric and floating gate polysilicon layers and the underlying substrate to form trenches. These trenches are then filled with a suitable material (such as oxide) to form STI structures. The portions of the gate dielectric and floating gate polysilicon layers between STI structures are defined by the STI structures and are therefore considered to be self-aligned to the STI structures. Typically, the STI structures have a width that is equal to the minimum feature size that can be produced with the processing technology used. STI structures are also generally spaced apart by the minimum feature size. Thus, the portions of the gate dielectric and floating gate polysilicon layers between STI regions may also have a width that is equal to the minimum feature size. The strips of floating gate polysilicon are further formed into individual floating gates in later steps. In some examples, floating gates may have dimensions less than the minimum feature size that can be produced using photolithographic patterning alone. Examples of scheme for forming such floating gates are provided in U.S. Pat. No. 6,888,755.
In NAND and other types of nonvolatile memories, the amount of field coupling between floating gates and the control gates passing over them (the coupling ratio) is carefully controlled. The amount of coupling determines how much of a voltage that is placed on the control gate is coupled to the underlying floating gates. The percentage coupling is determined by a number of factors including the amount of surface area of the floating gate that overlaps a surface of the control gate. It is often desired to maximize the percentage coupling between the floating and control gates by maximizing the amount of overlapping area. One approach to increasing coupling area is described by Yuan et al in U.S. Pat. No. 5,343,063. The approach described in that patent is to make the floating gates thicker than usual to provide large vertical surfaces that may be coupled with the control gates.
Individual portions of a memory array, such as strings of a NAND array, are generally connected together using conductive lines that extend across the memory array. Some conductive lines may be connected to portions of the substrate so that electrical connections are made to those portions. Generally, such connections are made by forming an opening in a dielectric layer that overlies the substrate and forming a conductive plug by filling the opening with a conductive material such as a metal or doped polysilicon. As memories shrink, the lateral dimensions of such plugs generally shrink along with other memory features. However, the vertical dimensions of such plugs may not shrink in proportion. This may be because the thickness of floating gates remains high, or for other reasons.
The aspect ratio of an opening is the ratio of the height of the opening to a lateral dimension.
Increasing aspect ratios present certain problems in forming good quality contacts. Plugs are generally made by depositing a conductive material so that the material fills an opening. However, where openings have high aspect ratios, the deposited material may not fill an opening fully. In some cases, voids are formed in the conductive material deposited in an opening.
Thus, there is a need for a method of forming a conductive plug in a manner that allows void-free plug formation even with high aspect ratio openings. There is also a need for a method of forming such a plug so that it has a low overall resistance. There is also a need for a method of forming such contacts in an efficient manner as part of memory array formation. There is also a need for void-free plugs with low resistance and for memory arrays having such void-free, low resistance plugs.
A composite plug is formed of a first conductive material deposited to partially fill an opening and a second conductive material that fills the remaining portion of the opening. The first material is chosen to have good filling characteristics so that no voids are formed in the first material even in an opening having a high aspect ratio. After the first material is deposited and the opening is partially filled, the remaining portion of the opening has a reduced aspect ratio. This remaining portion is then filled using a second conductive material that has low resistivity so that the plug has a low overall resistance.
The thickness of the first material is chosen so that, after the first material is deposited, the remaining portion of the opening has an aspect ratio that is calculated to be the maximum, or near the maximum that can be filled by the second material without producing voids. Thus, the thickness of the second material is made large where possible, while the thickness of the first material is made small. This provides low resistance because the resistivity of the second material is less than the resistivity of the first material.
In a NAND flash memory array, low resistance, void-free plugs may be formed at either end of a NAND string in openings having high aspect ratios. Plugs at either end may be formed simultaneously. At one end of such NAND strings, plugs are electrically connected together by a common source line. At the other end of such NAND strings, connection is made to bitlines that extend over strings.
Composite plug 334 formed by first conductive portion 328 and second conductive portion 332 has lower resistance than would be provided by a plug of similar dimensions formed by the first conductive material alone. Unlike a plug formed of the second conductive material alone, composite plug 334 does not suffer from voids. Thus, there are significant advantages over plugs formed from a single material.
While opening 324 as shown
One particular application where good, low resistance, void-free plugs are desirable is in contacting substrates used in memory devices. In particular, NAND flash memory devices are rapidly becoming smaller and the aspect ratios of openings used to form plugs are increasing. It is desirable to form such plugs having a low resistance but without voids. Plugs are generally used to connect to either end of a string of memory cells in such memories. A string is formed by a series of floating gate cells connected by doped regions of the substrate.
Tungsten is commonly used to fill openings and form plugs to contact a substrate. Tungsten has low resistivity allowing the formation of low resistance structures and is also capable of withstanding subsequent high temperature processing. However, in some designs, particularly newer designs with smaller features, the aspect ratio of the openings may be too high to form good plugs using Tungsten. Doped polysilicon is another conductive material that may be used to fill openings and form plugs. Polysilicon deposited by LPCVD generally forms good, void-free plugs even where openings have high aspect ratios. However, polysilicon has a higher resistivity than Tungsten, so polysilicon structures have higher resistance than similar Tungsten structures. To overcome these limitations, a composite plug is formed of polysilicon and Tungsten deposited in sequence.
Although the various aspects of the present invention have been described with respect to exemplary embodiments thereof, it will be understood that the present invention is entitled to protection within the full scope of the appended claims.
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|U.S. Classification
|International Classification
|Cooperative Classification
|European Classification
|Mar 8, 2006
Owner name: SANDISK CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HIGASHITANI, MASAAKI;REEL/FRAME:017433/0541
Effective date: 20051201
|Jun 1, 2011
Owner name: SANDISK TECHNOLOGIES INC., TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SANDISK CORPORATION;REEL/FRAME:026369/0278
Effective date: 20110404
|Mar 7, 2013
|Fee payment
Year of fee payment: 4
|May 25, 2016
Owner name: SANDISK TECHNOLOGIES LLC, TEXAS
Free format text: CHANGE OF NAME;ASSIGNOR:SANDISK TECHNOLOGIES INC;REEL/FRAME:038809/0472
Effective date: 20160516


text:
The presidential election, posts on this forum and elsewhere along with letters to the editor have made realize that we are in a culture war.
On one side are those that want to socialize the US, are intolerant of anything or anyone that doesnt share a liberal outlook, dare to disagree with blacks, hispanics and homosexuals. They want to label us homophobs or racists if we do.
They believe in wealth redistribution, a one world government and in the government taking care of everyone.
On the other side there are those that believe in capitalism, self-responsibility, independenc and freedom from the government, the government in a limite-capacity serving the people and America first.
We can and should argue on which side is right, but the issue I've come to realize is that the side that is 180 opposite than me is waging a war and my side is not fully engaged.
We are like McCain who stuck to public funding when B O broke his promise. Part of the reason that B O won is that he had far more funds than McCain, but McCain felt obligated to keep his promise. Well, all is fair in love and war.
We need to wake up and stand up. We need to fight for what we believe in and not be afraid to take a stance even when we are attacked and called racist, homophob, etc.