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37 posts tagged with camping and tent.
Displaying 1 through 37 of 37. Subscribe:
Pitch a tent!
I'd like to start camping again and need supplies, starting with a good tent: what specific brands and models do you recommend? [more inside]
How to fix a rip in the seam of a tent next to netting
We have a 6 inch rip in the seam of the roof of our tent. It is nylon attached to netting. Is this a glue fix or a sewing fix? Google is giving me mixed results.
De-stenching a canvas tent for one final voyage.
So, I've ruined my Kodiak canvas tent. What steps can I take to make it usable for one more trip? [more inside]
Best tent, backpack, sleeping bag for moderate weather?
I'm hiking out into the wild with a friend this autumn, and it's been decades since I last bought gear. I need a two-man tent, sleeping bag, backpack and other stuff. This won't be extreme camping, around 35-55°F at night, 3-4 days max. I'm looking for lightweight, durable, comfortable. Suggestions?
Long term camping in hot hot weather. What should I not forget!?
I will be doing about 4-5 weeks of camping in the mountains in West Virginia, Kentucky and Tennessee this Summer. I think I'm pretty well prepared, but I don't want to forget anything, and would love to hear your tips for what to bring, what to remember, etc. Extra bonus points for good recipes and tips on powering devices! [more inside]
I'll take a home in the woods by myself, if I can
I'm a fairly experienced camper, but I've never gone alone, so I booked a solo trip to spend a week in the woods this summer. I have some stuff (lantern, propane stove, mess kit, sleeping bag) but I'm missing most of the basics: a single person tent, mattress pad, food, mosquito gear. What do I need? What will I want? Once I get out there, what will I be shaking my fist at the uncaring sky for if I forget to bring it along? [more inside]
Help me figure out camping... in Africa?
Can you help me figure out whether a tent + mattress or a camping hammock would be best for camping out in Togo for 3 weeks? [more inside]
Motorcycle Camping in North-Western Mexico
I am looking for a quiet place to pitch a tent and do nothing for a few days preferably by the beach. I have gear and am familiar with travelling in Mexico.
Best backpacking guide... book, website, whatever!
I'm looking to start backpacking/rough camping this year, and I've had a hard time picking a guide. Can you recommend a book (preferred) or a website for this sort of thing? I've done some not-so-rough campground camping before, but it was alway drive-in camping. We'd love to start off with over nighters and work our way up from there. We don't know what type of pack/tent/gear to get at all. Bonus: guides for the tri-state (Philadelphia-New Jersey-Delaware) area camping/packing would be nice, too. Thanks!
Help me replace my REI Hobitat 6 tent with a better one
I have an old REI Hobitat 6 tent that has reached the end of its useful life. There were some things I really liked about that tent, and some things I really disliked. I'd like to find a tent that keeps what I liked and fixes what I disliked. [more inside]
Bike camping gear in northern Ontario
Help me prep for a 7-day, 700k bike trip through low-populated terrain! [more inside]
At - Tent - Tion
Any good tent recommendations? [more inside]
Where can I find a quiet, no rules place to camp in Northern MD or southern DE?
Help me think outside the box for tent camping in Northern MD or DE - where can I go besides a campground or sites in a Sate Park? I don't want suburbia in the woods! [more inside]
How to Build a Cavas Winter Tent?
I would like to build a canvas winter camping tent. I'm looking for materials and plans. Any recommendations? [more inside]
Help us live in a tent this summer!
Starting in a month, my girlfriend and I will be living for the summer in a 10x16, two room Kelty tent we bought on craigslist. We will be living/working on a farm outside of Olympia, WA. We'd love any advice/experience you might have on long-term tent living. We're super excited about it but we are aware it will suck sometimes... what sucked about it and how can we prepare for the suck? Lots more details inside on building a makeshift kitchen, hopefully cozy bedroom, etc. [more inside]
Camping between Charlotte and Philly
Camping filter: looking for fairly easy tent camping roughly halfway between Charlotte, NC and Philadelphia, PA. [more inside]
DIY tent upgrade - advice needed please
Our tent is OK but there's a gap between the sides and the groundsheet, which makes it rather chilly. How can I best make it more wind- and rain-proof? I think attaching a strip of some sort of waterproof material around the bottom of the sides, that could be tucked under the groundsheet, is the best option. But what sort of fabric? And how do I stop the water wicking up it from the ground and making the sides of the tent wet? [more inside]
Any advice for long-term tent camping?
Any advice for long-term tent camping? [more inside]
Is the instant tent a camping nightmare?
Do you, or does anyone you know, have a Coleman Instant Tent? What do you, or they, think of it? [more inside]
Tent poll: Two people and a dog?
Great backpacking tent for two people and a large dog? [more inside]
How does YOUR garden glow?
I'm going camping this weekend and want to deck out my tent in style. Where in the greater Los Angeles area can I get battery-powered string lights, ready-to-use EL wire, and other such self-sustaining glowy bits?
tent repair - sewing canvas help
Sewing-filter. I need to replace the fly-screens in a canvas tent. Hints/Tips? [more inside]
Best way to approach working 7 festivals in a row??
Festival Filter:I am working all summer at 7+ festivals around the UK.(details inside) What tent? What sleeping bag? Do's and Donts? General advice? [more inside]
I am just looking for a place to put my stuff...
Camping/OutdoorFurnitureFilter: Tent advice, also I am looking for a very specific type of camping/outdoor table that has eluded me for over a year now, details and picture inside. [more inside]
Am I safe to solo camp without a tent?
Solo tent-less camping - safety tips? [more inside]
To stick down that seam tape or not...
Following up to this question, my tent seam seal failed to stick down some of the taped seams that were coming untaped. Is it supposed to be able to stick them down or is that irrelevant as long as the seam seal goop absorbs into the stitching etc. I just thought that since when I bought the tent some of the taped seams were stuck down properly and some were peeling up, that maybe that was responsible for the leakage. [more inside]
To duct tape or not to duct tape...
I have this tent. The rainfly according to the box is polyester and the plastic window for the solar panel is PVC and the seams where the two materials join are 'taped'. (They are also stitched, whatever.) This seal between the two materials is leaking. Given the type of materials how do I patch this leak? (I have sprayed all interior seams with Silicone tent spray as instructed).
Lake District Recommendations?
UKFilter: Planning a camping trip to the Lake District in October looking for suggestions and recommendations of places to stay and things to do. [more inside]
Tent recommendations
Looking for recommendations for a two person tent that is similar to North Face's Peregrine, which is no longer made. [more inside]
Cool my Tent
How do I cool my tent for a Texas summer festival without electricity? [more inside]
tentfilter: tell me a good festival tent?
What price-range/type of tent should I get for festivals? (uk weather) [more inside]
Recommend an affordable and good 2-3 person tent in the UK
Recommend an affordable and good 2-3 person tent in the UK [more inside]
Starkville, MS to Yellowstone.
I'm planning a road trip to Yellowstone NP from Starkville, MS. Tips, suggestions of roads to take and places to stop, stay, eat, and see (we're tent camping, and we're talking spring break one year from now), we'll be in my 2006 Sentra. [more inside]
Camping (and general budget travel) in the Azores
Have you been to the Azores? (Or do you live there?) I'm seeking info about camping and other very low-budget traveling in the Azores. I would love to hear about any of the islands -- I'm also especially interested in Flores and Corvo if you know anything at all about the camping sites there. [more inside]
Sleeping gear for camping that is both light/ultralight and cheap?
I'm looking to put together sleeping gear for mild-weather camping, where low weight and low cost are equally important. So I'm seeking advice on the best way to balance these factors (since the lightest products seem to be the most expensive). [more inside]
Campgrounds for Dummies
Need advice for two tent camping newbies about to travel the country via Honda Accord. Is KOA generally reputable/nonscuzzy nowadays? Any other hints for this year's summer season? Recommendations on equipment? Do you have to reserve ahead of time (we are trying to not schedule ourselves too much!) or can you usually show up in the evening and get a spot? This question is as broad as can be - all advice welcome. We are happy to do some off-trail places but don't want to backpack necessarily. [more inside]
What's the best 'average tent'?
I'm looking to upgrade my tent to something a little more spacious. I'm on a budget of not more than $150 and want something durable, easy to set up, and big enough to stand up in (I'm 6'3"). We're thinking a 6 person tent would be a comfortable size...for the two of us. Our current tent is a 4-man size. [more inside]
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subset: commoncrawl


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Perfect Frenchtown location, in the heart of the bus. district, near the corner of Harrison and Bridge Street. This 600 square foot retail store has good visibility to pedestrian and car traffic. Great opportunity for a small business, retail shop or a destination shop or office. This 600 sq ft shop can be combined with the store next door at 108, creating a single 1,200 sq.ft store.
Listing Courtesy of COLDWELL BANKER


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Intercept Pharmaceuticals Inc (ICPT): David Shapiro , CMO and EVP – Development of Intercept Pharmaceuticals Inc sold 3,545 shares on Sep 26, 2016. The Insider selling transaction was reported by the company on Sep 28, 2016 to the Securities and Exchange Commission. The shares were sold at $165.40 per share for a total value of $585,199.69 , the company said in a SEC Form 4 Filing.
Other Insider transactions have been reported by the company according to SEC Form 4, on Sep 22, 2016, Mark Pruzanski (CEO & President) sold 35,000 shares at $165.00 per share price.On Aug 2, 2016, Rachel Mcminn (Chief Strategy Officer) sold 125 shares at $176.57 per share price.Also, On Jul 7, 2016, Barbara Gayle Duncan (Chief Accounting Officer) sold 146 shares at $145.11 per share price.On Jul 7, 2016, David Shapiro (CMO and EVP – Development) sold 163 shares at $145.11 per share price.
Intercept Pharmaceuticals Inc: On Tuesday, Sep 27, 2016 heightened volatility was witnessed in Intercept Pharmaceuticals Inc which led to swings in the share price. The shares opened for trading at $165.47 and hit $172.62 on the upside , eventually ending the session at $172.13, with a gain of 3.68% or 6.11 points. The heightened volatility saw the trading volume jump to 3,67,213 shares. The 52-week high of the share price is $217.99 and the company has a market cap of $4,256 M . The 52-week low of the share price is at $89.76.
Company has been under the radar of several Street Analysts.Intercept Pharmaceuticals Inc is Downgraded by Laidlaw to Sell while Lowering the Price Target of the company shares to $ 105 from a previous price target of $345 . Earlier the firm had a rating of Buy on the company shares. The Rating was issued on Aug 5, 2016.Intercept Pharmaceuticals Inc is Initiated by Cantor Fitzgerald to Sell and the brokerage firm has set the Price Target at $58. The Rating was issued on Jul 6, 2016.
Intercept Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry. The Companys product candidate obeticholic acid (OCA) is a bile acid analog a chemical substance that has a structure based on a naturally occurring human bile acid that selectively binds to and activates the farnesoid X receptor (FXR). The Company is also developing other products INT-767 and INT-777 for the treatment of fibrosis and type 2 diabetes. OCA has been tested in five placebo-controlled clinical trials including a completed Phase III clinical trial in patients with primary biliary cirrhosis (PBC) and two Phase II clinical trials in patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). OCA met the primary efficacy endpoint in each of these trials with statistical significance.


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Check in from 14h / Check out prior to 11h
Hotel Apple Inn: Find photos, reviews, information, amenities and compare prices for 2 stars hotels in Amsterdam, Netherlands.
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Receptos, Inc. (RCPT) Q4 2013 Earnings Conference Call March 5, 2014 5:00 AM ET
Faheem Hasnain – President and Chief Executive Officer
Graham Cooper – Chief Financial Officer
Sheila Gujrathi – Chief Medical Officer
Koon C. Ching – Credit Suisse Securities
Marko K. Kozul – Leerink Partners, LLC
Liana Moussatos – Wedbush Securities, Inc.
Good day ladies and gentlemen, and welcome to the Receptos Fourth Quarter 2013 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this conference is being recorded.
I would now like to turn the call over to Faheem Hasnain, President and Chief Executive Officer. Please go ahead sir.
Faheem Hasnain
Good afternoon and thanks everyone for joining us for the Receptos fourth quarter 2013 earnings call. With me today are Graham Cooper, our Chief Financial Officer and Sheila Gujrathi, our Chief Medical Officer. Today's call is also being webcast live on our website and will be available for replay until March 17th.
Before we begin I'll ask Graham to handle the forward-looking statement disclaimer. Graham will walk you through our financial results, followed by an update on our clinical development program that Sheila and I will cover. And after that, we're happy to take any questions you might have. Graham?
Graham Cooper
Thanks Faheem. Please note that except for statements of historical facts, the statements in this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Please see the forward-looking statement disclaimer on the company's earnings press release issued after the close of market today, as well as the risk factors in the company's SEC filings included in our Form 10-K for the year ended December 31, 2013 that will be filed shortly.
Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made and the facts and circumstances underlying these forward-looking statements may change. Except as required by law, Receptos disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
I will turn to the financial results for the fourth quarter. For the three months ended December 31, 2013, Receptos reported a net loss of $15.2 million or $0.86 per share compared to a net loss of $4.5 million or $3.08 a share for the fourth quarter of 2012.
Total revenues for the fourth quarter 2013 were $773,000, compared to $3.8 million for the fourth quarter of 2012. Total operating expenses for the fourth quarter of 2013 were $15.9 million compared to $8.3 million for the fourth quarter of 2012.
R&D expenses were $12.6 million for the fourth quarter of 2013 compared to $7.5 million for the fourth quarter of 2012. The increase in R&D expense is primarily related to increased Phase 2 clinical trial activity, commencement of the Phase 2 trial of RPC1063 in ulcerative colitis and start up costs related to the Phase 2 portion of our Phase 2/3 trial of RPC1063 in multiple sclerosis. .
G&A expenses were $3.2 million for the fourth quarter of 2013 compared to $803,000 for the fourth quarter of 2012. The increase in G&A cost is primarily related to an increase in personnel costs, additional stock comp expense and additional expenditures on outside services, including consulting, legal and accounting fees, market research and insurance.
As of December 31, 2013, Receptos had $69.5 million in cash equivalents and short-term investments and debt with a principal balance of $4.9 million. In early 2014 we completed an follow-on equity offering, the net proceeds of which were $110 million approximately. This substantially strengthened the financial position of the company. The pro forma cash and cash equivalent balance as of December 31, 2013, including the net proceeds of the offering was approximately $179 million.
Following the completion of the January offering, we had a total of 22.2 million shares outstanding or approximately 23.1 million shares on a fully diluted basis at today's share price.
I will now hand the call back to Faheem.
Faheem Hasnain
Thanks Graham. So there are three major topics that I want to cover on the call today. First, with regard to RPC1063 in multiple sclerosis, I want to remind you of where we stand with the program and the important data that we expect to report later this year. I'll also cover the opportunity for RPC1063 in ulcerative colitis which we believe is substantial and probably under appreciated by the market.
And, finally, I'll give you an update on our pipeline programs, including our anti IL-13 antibody for eosiniphilic esophagitis as well as our GLP-1 Receptor Modulator Program. I'll then ask Sheila to provide some further details on our clinical progress across these programs including the new trials that we have in the works.
So as you're aware, we completed enrollment of the Phase 2 portion of RADIANCE and relapsing MS in October and performed an interim analysis of the data in the fourth quarter of 2013. This was an important milestone for our company. As a result of this review and based on the confidence that we took from the preliminary data, we chose to initiate the Phase 3 portion of RADIANCE in relapsing MS. I'll ask Sheila to review with you the interim analysis in a moment.
As you will recall, we have a SPA from the FDA on this trial which is designed to enroll 1,200 patients with relapsing multiple sclerosis to treatment with orally administrated RPC1063 or injectable Avonex.
The primary end point of this first Phase 3 trial is annualized relapse rate after two years of treatment. Initiating this trial before the completion of the Phase 2 trial should allow us to greatly compress the overall development timeline as we are able to hit the ground running with site that have already been actively enrolling in the Phase 2 trial.
Our second Phase 3 trial which has also received this SPA from the FDA is designed with a one year primary end point. And as such we do not expect it to be rate limiting. We expect that if the data continue to payout as hoped, RPC1063 can potentially be the next S1P1 receptor modulator into the market behind Gilenya.
Now speaking of Gilenya, as you know the markets for oral therapies continues to take shape. Oral therapies are solidifying their position in the market. Now exceeding 25% of the total scripts in the U.S. and growing every quarter.
Gilenya produced $1.9 million in sales in 2013 up from $1.2 billion in 2012 and its market share in the U.S. has increased even in the Phase of the Tecfidera launch. It now represents approximately 10% of the total U.S. market share on a scripts basis and the analysts are projecting that it will continue to grow significantly.
Tecfidera has also become an important factor in the market for oral MS therapies that achieved $876 million in sales in 2013 and exited the year with nearly 15% market share. Similar to Gilenya, analysts are projecting blockbuster status for Tecfidera as more and more patients make the switch to oral therapies.
So this shift in market share is coming with the expense of the legacy injectable therapies all of which have seen market share declines in the past 12 months. So clearly, there continues to be a need for next generation oral therapies especially those that improve upon the current standard of care.
While the current oral therapies do offer improved efficacy and convenience, they have a number of safety and tolerability issues which limit their uptick. In the case of Tecfidera, patients often experience tolerability issues including GI flushing and in the case of Gilenya there continues to be a negative perception as to say a good safety profile. Unfortunately, there is no cure for patients infected with MS.
Patients start on a drug and generally continue until they relapse prompting a switch. Now if we're successful getting up this E-1063 approved, we expect that when it arrives in the market, there will be a substantial group of patients in need of a new world therapy with an enhanced profile versus other approved drugs.
Switching gears a bit, we are also enthusiastic about the opportunity represented by RPC1063 in ulcerative colitis and IBD more generally. Current therapies can be used to treat inflammation in the intestine. However a long term use for these types of anti-inflammatory agents which include injectable and infused biologics is associated with limited durable efficacy and significant side effects.
As a result there remains a significant unmet need for effective and well tolerated new therapies, particularly new oral therapies in the maintenance setting. Now this represents a substantial market opportunity. Let me remind you that the ulcerative colitis market in terms of the number of patients is actually substantially larger than the multiple sclerosis market with approximately 1.1 million patients in the U.S. and approximately 700,000 patients in other native markets.
Now it was also precedent for success of lymphocyte trafficking agents for the treatment of inflammatory bile diseases. As you may know Takeda drugs, vedolizumab is an IV infused biologic which effects the trafficking of similar subpopulations of lymphocytes as RPC1063 does. Thus we view the evidence of clinical efficacy and safety demonstrated by vedolizumab is clinically relevant rational and proof of concept for our approach. In December our joint panel of members from the FDAs GI Drug Advisory Committee nodded to recommend approval of vedolizumb for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease
All 21 committee members voted that the benefit there were the risks to support approval for UC and for Crohn's diseases 20 of the 21 panelist voted to support approval for that indication. The PDUFA date for vedolizumb is in May and based on the mechanism of action of RPC1063 the President of other lymphocyte trafficking agents that have shown us seeing this indication of the test and our overall safety and tolerability profile. We believe that we have the potential to be the first in class and our best in class for the treatment of ulcerative colitis.
And as you would anticipate, if we show efficacy in ulcerative colitis, it would be natural for us to think about pursuing the program into Crohn's disease as well. The Crohn's market represents another million or so patients worldwide.
And more broadly as we have advanced the RPC1063 program in both the relapsing MS and ulcerative colitis indication and gained important safety experience with this compound we believe there exist attractive expansion opportunities for this molecule in other areas of neurology and immunology. For example progressive forms of MS maybe addressable with the S1P receptor modulator mechanism.
Novartis is pursuing a Phase III trial Gilenya and primary progressive MS, with data expected in the back half of this year. If that trial is positive, it opens the door for us to pursue that and potentially other neurodegenerative indications with RPC1063. Other study results including positive clinical data in psoriasis with another S1P receptor modulator and preclinical data in a number of animal models including [indiscernible] provide scientific rational, that RPC1063 may work in other immunologic conditions. We are in the planning stages for exploring additional indications that we may purse for RPC1063.
Now finally I'll touch on our pipeline beyond RPC1063. With regard to our anti-IL-13 antibody, we believe that it has the potential to have an impact in eosinophilic esophagitishagitis, an emerging indication with significant unmet need that has only been recently diagnosed in the last 10 years to 15 years.
Now, while it is still an orphan indication, it has been growing in prevalence as awareness increased. Patients with eosinophilic esophagitishagitis or EoE as we call it, can have a range of symptoms including food impaction, difficulty swallowing and a result in weight loss or failure to thrive.
And while there are no approved therapies, the majority of patients are treated with swallowed steroids, which are associated with a number of side effects and a limited duration of efficacy. This program is Phase II ready. And, we expect that our next step would be to initiate a randomized trial in an EoE patient population and Sheila will comment more about that later.
And while our oral small molecule GLP-1 receptor Allosteric Modulator Program is still early, we are excited nonetheless exited about the novel, mechanistic approach and the sizable opportunity that this innovative program represents. Orally administered lead compounds have shown single agent efficacy in a diabetic disease model, as well as, activity that's synergistic with metformin in combination studies. And we intend to conduct IND-enabling studies in this program later this year.
So, that's a thumbnail sketch of our current development programs. I'd like to now ask Sheila to give you an update on some of the specifics in terms of our ongoing and planned clinical trials.
Sheila Gujrathi
Thanks Faheem. I'll be providing an update on our Phase 2/3 S1P1 receptor modular trial and we will optimize [indiscernible] which we refer to as RADIANCE. As well as a Phase 2 trial called TOUCHSTONE. I'll then cover our anti-IL-13 antibody program and eosinophilic esophagitishagitis.
And as Faheem noted the headline today is really the favorable results of our interim analysis of the Phase III MS we saw preformed in the fourth quarter of 2013. We have focused our review on several potential product attributes that we believe may represent important differentiation from the other SMP receptor modulators on the market or in development.
We are pleased to report that overall our differentiation profile continues to appear intact including the overall adverse event profile which appeared relatively balanced between 1063 and the placebo group. The cardiovascular profile including the study on heart rate effects, liver enzyme effects and preliminary evidence of clinical activity as well as reduction on lymphocyte count.
Based on the results of that review we made the decision to initiate the Phase 3 portion of the RADIANCE trial. And we randomized our first patient into Phase 3 in late December and since then we have been able to enroll additional patients around the world and the week in the first three weeks of the share.
This first trial is designed as a head-to-head superiority study with two doses of orally administered RPC1063 versus injectable Avonex. We did the same two doses, 0.5 milligram and 1 milligram that we are starting in the Phase 2 trial. The primary endpoint for this trial will be reduction and illustrate after two years of treatment.
The second Phase 3 trial which is designed as a one year study will start after we obtain the top line results of the current Phase 2 trial. Because this trial will be shorter in duration than the first, we expect that we will be able to complete both trials at about the same time in order to optimize our overall development timeline.
So the result of ongoing Phase 2 trial, we continue to expect the full top line results to be available in mid 2014. We involved human entity patients in this study, substantially greater than the 210 plan, as a result of momentum that's build with investigators in the latter part of the enrolment period.
The primary end point on the placebo control trial is the reduction of a cumulative number of total gadolinium-enhancing lesions determined by MRI from week 12 to week 24 of study treatment.
Now turning to the UC program, we are also conducting a Phase II trial of RPC1063 and patients have modestly daily active also described that. This trial design can enroll about 180 patients, randomized at the same two dose levels of RPC 1063 that is 0.5 milligram and 1 milligram of placebo.
The primary objective of TOUCHSTONE is to compare the efficacy of RPC1063 for the induction of clinical remissions in patients with active ulcerative colitis after 8 weeks of treatment. This trial continues to enroll at pace, and as we have previously stated we expect that we will report the results of this trial in mid-2014 subsequent to the RADIANCE Phase 2 results in relapsing MS.
The FDA has indicated that the results of the study are statistically and clinically persuasive, TOUCHSTONE quick count is one of our Phase III trials in ulcerative colitis, meaning that we would only need then to conduct one additional pivotal induction study and one Phase 2 maintenance study for approval.
So I've covered the update on the trials for RPC1063 and relapsing MS and ulcerative colitis. Let me now turn to RPC4046, which is our anti-IL-13 antibody for the treatment of treatment of eosiniphilic esophagitis. As Faheem mentioned, this is an urban indication where treatment options are limited, there appears to be strong scientific rational from a preclinical and clinical basis to support a directed anti-IL-13 therapy in EoE, including esophagitishigil over expression of our IL-13 cytokine, the ability of IL-13 to induce expression of e attacks in 3 and periostin which are the most highly expressed proteins in EoE as well as the ability of IL-13 to promote both inflammation and fibrosis in esophagus.
I want to also remind you that there appears to be validation of this mechanism in other allergic meted disease areas. Specially IL-13 antagonist have demonstrated efficacy in pre-clinical models of allergy and recently have shown clinical activity in asthma and eosinophilic esophagitishagitis patient.
In terms of our clinical development plan, we intend to conduct the Phase II EoE trial as a randomized double blind placebo control study in patients with active EoE. We plan to enroll approximately 90 patients to access two subcutaneous RPC4046 compared to placebo. The primary objective of the Phase II trial will be to determine whether treatment with our molecule is efficacious by histologic improvements of eosinophilic counts at week 12.
We also plan to explore potential PDUFA diagnostic biomarkers for efficacy in this proof-of-concept study. We did hold a successful pre-IND meeting with the GI division of the FDA in December where we obtained agreement on the general design of the non-clinical program and the clinical Phase II study design. And we do plan to file an IND in the first half of 2014. Because Phase I trials have already been conducted for this molecule [indiscernible], we're trying to treat into the Phase II trial once we've filed the IND.
So, that covers the update on our clinical programs, I will now turn the call back to Faheem.
Faheem Hasnain
Thank you Sheila. So to summarize on RPC1063. We continued to execute on the timeline that we laid out at the time of the IPO. We completed the interim review of the Phase II portion of RADIANCE in relapsing MS in December which appear to confirm our differentiation profile and allowed us to trigger the initiation of the first Phase III trial. We continue to expect top-line Phase II results in the middle part of this year and if those results are positive, we plan to initiate the second Phase III trial shortly thereafter.
Now based on our trajectory, we have the potential to be the next S1P1 receptor modulator into the market. A market that's growing in overall size and where oral therapies appear well positioned to continue to take share from injectable therapies.
We have a large and perhaps even larger opportunity in UC, and IVD generally where our current Phase II trial is also on track to read out in mid-2014 after the relapsing MS data. I do believe that success from this proof-of-concept trial could create an upside for the program that is yet to be fully appreciated given the size of the patient population and the unmet need.
And in addition, we are accessing the attractiveness of other potential indications for RPC1063, neurodegenerative disease, Crohn's disease and other areas of immunology, were all in the target list for us. We'll continue to follow the data from preclinical and clinical studies but they're own and thus conducted by others as they become available.
We will plan to make new investments in follow-on indications for RPC1063 where the data is supportive. And let me remind you that with regard to RPC1063 in all indications, we own 100% of the asset and we have what we believe a strong IP running until 2029 without adding time for data exclusivity.
And with regard to the pipeline beyond RPC1063, we're making progress in building out the portfolio with other product candidates addressing other therapeutic indications including EoE and Type 2 Diabetes, both of which could represent substantial opportunities whether we pursue them alone or in partnership.
And broadly from a corporate standpoint Receptos has never been stronger, having raised over a $100 million in additional capital in January, we are well funded through the Phase II data and beyond which will allow us strength and flexibility in whatever we choose to do whether it be negotiating favorable partnership terms or taking our programs further into the clinic.
And finally, I want to take a moment to thank the members of the Receptos team that have created all of this progress. We have incredibly engaged, experienced and dedicated team of people that come to work everyday excited and ready to drive our programs forward. I'm extremely appreciated of everyone's efforts in our share purpose to create meaningful new therapies for patients.
And with that, we'll be happy to answer your questions.
Question-and-Answer Session
(Operator Instructions) The first question comes from Ravi Mehrotra from Credit Suisse.
Koon C. Ching – Credit Suisse Securities
Hi, thank you for taking the question. This is actually Koon asking a question on behalf of Ravi. I just wanted to know if you can provide us with your latest thinking on the confirmatory Phase III trial design for RPC1063 and MS, specifically what might you use as a comparator in that trial. Thank you.
Faheem Hasnain
Sure and thanks Birchenough. Thanks for the question and just to clarifying, I'm going to actually discuss the pivotal trial design for this third pivotal Phase 3 MS, so that's the Phase 3 portion of RADIANCE. And so the way that study is designed and again it is occurring in more patients, it's basically already studied, and exploring the two dose level with the 1063 that we had in Phase 2. So the 0.5 milligram and 1.0 milligram dose level compared to Avonex and which doesn't know and BMI injection is given once a week and it is standard-of-care for MS patients across the globe.
This is a two-year study design, and so the two-year trial duration, and the primarily end- point again is the priority design of reduction in Annualized Relapse Rate at the end of 24 month of treatment. And so that is the current design, and it's a double-blind, double-dummy design and so patients would be receiving either Avonex or placebo injection and 1063 or placebo 1063.
And for the second pivotal study, our current design is a one year study, that is looking at the two dose over the 1063, again compared to Avonex, and the benefits of this approach are several but one of the primary benefit is that we are going to be able to pull data from both of a pivotal study to increase our products to look at important secondary endpoints of 15 approval from the FDA around this analysis approach doing the process that we had not only for the first pivotal but also the second pivotal study. So we do have a spot again and place for both pivotal studies at this time.
The next question comes from Marko Kozul from Leerink Partners.
Marko K. Kozul – Leerink Partners, LLC
Everybody congrats on new progress.
Graham Cooper
Thanks Marko.
Marko K. Kozul – Leerink Partners, LLC
Thanks. The question I wanted to ask was on the RMS front for 1063, I think you plan on running a Phase 3 review study against Tecfidera as the active comparator. Could you give us a preview of what you are thinking possible in terms of trial design?
Graham Cooper
Yes, Marko so, we haven't defined. So we have that trial design yet but let me kind of come back to the base concept. We fundamentally believe that, we have a profile and this certainly is bearing out in a market research with position that we have a profile that can go to toe-to-toe with Tecfidera. In fact, as we – when we got the results from that market research, it really showed that we could see a potentially equivalent share split between patients going either to Tecfidera or RPC1063. So, fundamentally it's really a marketing question in terms of what level of evidence do we need to bring to the table to kind of further our position and further our story against Tecfidera.
So we wouldn't do it in the context of a registration of study but doing it has a 3b, I think is a real possibility, it's a study that we probably wouldn't need to start around the 2016 timeframe. But we are in the process of really thinking through what our marketing approach would be? What our positioning would be? And thus what further evidence we need to bring beyond the registration of studies. Sheila, if you want to add any comments on that?
Sheila Gujrathi
That really covers our strategic approach, I think in terms of the differentiation assay that we really focused on in terms of demonstrating important data from that study design, we of course didn't look at efficacy measures and we will look at Annualized Relapse Rate, our disability and our potential improvements and reduction in brain atrophy which we do think overall that mechanism cross of SMP1 receptor modulator test, churn better [indiscernible] areas than Tecfidera.
And then of course we will spend some time characterizing the safety and tolerability advantages, but sensitivity they could offer with Tecfidera, and so all of that would be front and center in terms of we can share videos outline those data element in the studies that we would design.
Marko K. Kozul – Leerink Partners, LLC
Terrific, and I hear if you see follow-up, ulcerative colitis with 1063, could you review for us the Phase II UC trial design and then enrollment criteria for the open-label extension, and then what proportion of patients are transitioning into the expansion and what does this mean or how do they compare to your internal expectations. And then just finally, if you could review for us some dollar terms, the UC markets versus MS, thanks.
Sheila Gujrathi
So, the Phase II UC trial design again called TOUCHSTONE, it's a purity study, it's a placebo controlled, doubled-blind randomized global, clinical trial. We are studying at the same two dose levels as 1063 for 0.5 milligram and 1 milligram dose level compared to placebo. During the dose titration period and then eight week treatment period and the primary endpoint of the study is looking at, that's going superior design induction of clinical emission after eight weeks of treatment.
And so, so the design is it is robust with powered at 180 patients, for that 60 patients for treatment of them, and based on [indiscernible] Phase III design in this indication and this is why we did ask the SK, if to be considered a potential pivotal registration side, because the – trial design in Phase III is identified – is based with similar identical to this approach.
So, the studies are going well and then as you mentioned we have our maintenance, part of that trial design, patient through showing clinical improvement. We are continuing to allow to growth maintenance period and also there is an open-label extension period, where our patients from the double-blind portion or from the maintenance period at any time could go into that open-label extension period. And what I can say today is that there is a number of patients who are crossing over into the maintenance period are meeting our expectations, from a clinical improvement perspective and so everything that we are seeing today in terms of looking at anecdotal data from clinical trial itself we are looking at against the portion of patients, we continue to move forward in the maintenance period, exclusively consistent with other effectively two therapies in terms of data looking from their clinical programs. I think the last part of your question, Marko is around, was that commercial opportunity.
Marko K. Kozul – Leerink Partners LLC
Yes, that's correct.
Sheila Gujrathi
And so from our perspective, as you mentioned it's a quite sizeable market and when we've done actually market reaching this area since very compelling, as you probably know there are some all therapies that are used in ulcerative colitis, specifically age or size, 7 to 70 but they really are not robust immuno therapies. And they have a number of safety and tolerability issue, because they are such cut many question, scope, we do really think that.
We have a chance to be a one of the first, effective UC therapy that are – effective overall maintenance therapy, and therefore when we went testing our profile and market research, it does appear to been chosen before biologics. And so it could be again a first-line oral maintenance treatment after a 5 day safe trajectory example.
So, we are also designing our clinical program in well 5 to 8 days failure and to position that potentially against this oral maintenance therapy. So because of that I think we are seeing very good uptick in the markets we have been doing before anti-TMS and before vedolizumab. And actually the other orals that are being tested in development today don't seem – there is simply some safety concerns around them. So again, our profile is resonating very well with clinicians.
Marko K. Kozul – Leerink Partners, LLC
Appreciate you taking the questions and look forward to you to see updates on the data in mid-year. Thanks a lot.
Faheem Hasnain
Thanks, Marko.
(Operator Instructions) The next question comes from Liana Moussatos from Wedbush Securities.
Liana Moussatos – Wedbush Securities, Inc.
Thank you for taking my question. Can you give us any kind of operating expense guidance for 2014 and do you plan to start any of these new indications or primary progressive trials by the end of this year?
Graham Cooper
Liana, it's Graham. So, unfortunately we're really not in a position to provide operating expense guidance for this year. The reason for that is that we have some very important decision points coming up based on the RMS RADIANCE Phase 2 data in mid part of the year and subsequently the UC data. So, for example, if the data from RADIANCE is positive, we may choose to initiate the second Phase 3 trial and incur startup cost related to that trial later in 2014 and likewise for alternative clients the TOUCHSTONE results were positive. We may start to incur cost there. And then as Sheila and Faheem both mentioned, we have other follow-on opportunities in other areas that we could pursue. So, we've chosen not to give specific guidance for 2014 at this point because anything we say is likely to change based on the data and the clinical development plans.
Faheem Hasnain
But to be clear, Liana, the other indications, so if you just think about Crohn's, primary progress of MS, other spots that we take RPC1063, those are success scenarios and what I mean by that is that obviously first and foremost, we will be using a positive MS study, a relapsing MS study, our Phase 2 as a gate for anything further that we do in MS. And certainly positive UC study would be a gate for anything we consider doing in Crohn's disease. So, really any of those other indications that we are contemplating is really in anticipation of success scenario where these Phase 2 read out.
Graham Cooper
I think the most important point relative to the cash and the runway is just we are going to have plenty of cash post the data, but it tends to be RADIANCE as well as the TOUCHSTONE data to be able to make your decision later this year.
Liana Moussatos – Wedbush Securities, Inc.
Do you anticipate that the first half spend this year will be significantly higher than the first half of last year or the second half of last year?
Graham Cooper
Yes, I think it will go up. I don't know about significantly, but it will go up because we're in the first swing on Phase 3 cost with our MS cost.
Liana Moussatos – Wedbush Securities, Inc.
Okay. Thank you very much.
Faheem Hasnain
Thanks, Liana.
At this time, I am showing no further questions. I would now like to turn the call back over to Faheem Hasnain.
Faheem Hasnain
Okay. Well, thanks all for joining us on this call. We appreciate your support and we look forward to continuing to keep you updated as our development programs progress. So thanks, and good afternoon, everybody.
Operator: Ladies and gentlemen, that does conclude the conference for today. Again thank you for your participation. You may all disconnect. Have a good day.
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New Jersey will receive $1.9 million in a multi-state settlement with Toyota Motor Co., resolving allegations that Toyota covered up known safety issues associated with sudden and unintended acceleration in certain Toyota and Lexus models.
In the settlement, the Japan-based company agreed to pay $29 million to 29 states and a U.S. territory for allegedly failing to report the issues in a timely manner, plus make changes to its corporate culture and chain of command, state Attorney General Jeffrey Chiesa announced Thursday.
Since 2009, Toyota has recalled more than 14 million vehicles worldwide for the unintended acceleration problem in various models when gas pedals would stick to floor mats, causing complaints, crashes, injuries and deaths.
In December, Toyota reached a settlement worth more than $1 billion - the largest in U.S. history relating to auto defects - to reimburse U.S. consumers affected by the safety issues. The U.S. Department of Transportation's National Highway Traffic Safety Administration also in December fined Toyota a record $17.4 million related to a 2012 recall of a Lexus model.
The multi-state investigation in which New Jersey was one of the lead states found that poor communication between Toyota's corporate headquarters in Japan and its U.S. operations contributed to the problems.
The settlement also prohibits Toyota from promoting its vehicles' safety without supporting engineering data; reselling a vehicle with alleged safety defects without notifying the buyer and certifying it has been fixed; and misrepresenting the reason for an inspection or repair, if Toyota instructed customers to bring their car to a dealership for that purpose. Toyota also must exclude any vehicle acquired through "lemon law" proceedings or voluntarily repurchased by Toyota from its "Toyota Certified Used Vehicles" or "Lexus Certified Pre-Owned Vehicles" categories.
"This is an important settlement, not only because of the dollars, but because the terms are designed to help make Toyota more accountable, responsive and vigilant regarding vehicle safety issues," Chiesa said in a statement.
Email: email@example.com


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W/S S-10 Implementation Delayed Per 2017 IPPS Final Rule
|On Friday July 29, 2016 HFS posted and issued an email highlighting CMS Transmittal number 1681 to Publication 100-20 that provided guidance for accepting FY 2014 amended cost reports from hospitals requesting to revise Worksheet S-10 in light of CMS's proposal to begin using Worksheet S-10 data to determine uncompensated care payments starting in FY 2018.
On August 2, 2016 CMS published the FY 2017 Final Rule and in this rule they delayed the implementation of using the Worksheet S-10. Below is an excerpt relating to this with the link to the final rule also shown below.
At this time, we are not finalizing a future transition to using Worksheet S-10 data to determine the amounts and distribution of uncompensated care payments. Specifically, we had proposed to use a 3-year transition beginning in FY 2018 where we use a combination of Worksheet S-10 and proxy data until FY 2020 when all data used in computing the uncompensated care payment amounts to be distributed would come from Worksheet S-10. In light of public comments, we believe it would be appropriate to institute certain additional quality control and data improvement measures to the Worksheet S-10 instructions and data prior to moving forward with incorporation of Worksheet S-10 data into the calculation of Factor 3. Consequently, we are not finalizing our proposal to begin to incorporate Worksheet S-10 data into the computation of Factor 3 for FY 2018. In light of the significant concerns expressed by commenters regarding the Worksheet S-10 data, we are postponing the decision regarding when to begin incorporating data from Worksheet S-10 and proceeding with revisions to the cost report instructions for Worksheet S-10. We expect data from the revised Worksheet S-10 to be available to use in the calculation of Factor 3 in the near future, and no later than FY 2021. With regard to how Factor 3 will be computed in FY 2018 and subsequent years, we intend to explore whether there is an appropriate proxy for uncompensated care that could be used to calculate Factor 3 until we determine that data from the revised Worksheet S-10 can be used for this purpose. We will undertake further notice-and-comment rulemaking to address the issue of the appropriate data to use to determine Factor 3 for FY 2018 and subsequent fiscal years.
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Health Financial Systems
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HSS Jobber Drill - Dia: 11/64" x Length: 11/64" Premium Quality Drill for use with Alloy Steel, Cast Iron, Non Ferrous Metals & Plastic High Grade M2 Alloyed HSS Steel to DIN 338
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Part No. 902 0658Categories: Drill Bits & Accessories
|L&S Part No.
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Key Features:
The Kramer 1:1 Computer Graphics Video Line Amplifier is a line driver that compensates for signal losses (signals exceeding UXGA, 1600 x 1200 pixels) in long cable runs. The line amplifier is applicable for dual monitor and presentation systems as well as for remote transmission and cable equalization.
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Sangam Hotel places you within a 10-minute stroll of ISKCON Madurai, Sri Sri Radha Mathurapati Temple and Sri Meenakshi Temple. This 3.5-star hotel has 60 guestrooms and offers an outdoor pool, free in-room WiFi, and free self parking. It's in central Madurai and also close to Meenakshi Amman Temple and Kazimar Big Mosque and Maqbara.
Start your day off right with a free buffet breakfast. This hotel serves as home to a bar, along with a restaurant that specializes in international cuisine. Savor a meal from the comfort of your room with room service.
The 60 rooms are air-conditioned and have an array of amenities, including refrigerators, minibars, and coffee makers. Guests can expect to find free WiFi and LCD TVs with digital channels. Bathrooms offer hair dryers and free toiletries. Free bottled water, safes, and phones are other standard amenities.
Property features
Sangam Hotel features an outdoor pool, free WiFi in public areas, and a business center. You can take advantage of free parking, along with limo/town car service. Helpful staff can provide dry cleaning/laundry services and tour or ticket assistance.
- Free buffet breakfast
- Free WiFi in rooms and public areas
- Free parking
- Onsite dining
Sangam Hotel
Hotel Amenities
Room Amenities
Sangam Hotel offers 60 air-conditioned accommodations with minibars and safes. Refrigerators and coffee/tea makers are provided. Bathrooms include complimentary toiletries and hair dryers.
Guests can surf the web using the complimentary wireless high-speed Internet access. LCD televisions come with digital channels. Housekeeping is provided daily.
- Air conditioning
- Phone
- Refrigerator
- Minibar
- Coffee/tea maker
- Free bottled water
- Daily housekeeping
- Free toiletries
- Hair dryer
- In-room safe
- Rollaway/extra beds available
- Cribs/infant beds available
- Digital TV service
- Free WiFi
- Room service
Hotel Amenities
The hotel offers a restaurant. A bar/lounge is on site where guests can unwind with a drink. A complimentary breakfast is offered. Public areas are equipped with complimentary high-speed wireless Internet access.
Business amenities at this 3.5-star property consist of a business center, limo/town car service, and meeting rooms. This Madurai hotel also offers an outdoor pool, tour/ticket assistance, and dry cleaning/laundry services. Complimentary self parking is available on site.
- Total number of rooms - 60
- Number of floors - 1
- Bar/lounge
- Business center
- Free breakfast
- Dry cleaning/laundry service
- Elevator/lift
- Tours/ticket assistance
- Free WiFi
- Limo or Town Car service available
- Meeting rooms
- Restaurant
- Free self parking
- Shopping on site
- Outdoor pool
Family Friendly Amenities
- Family Hotel
- Outdoor pool
- Free Wi-Fi
- Rollaway/extra beds available
- Refrigerator
Available in all rooms: Free WiFi
Available in some public areas: Free WiFi
Free self parking
Where to Eat
Guests are offered a complimentary buffet breakfast.
Onsite venue - This restaurant specializes in international cuisine and serves breakfast, lunch, and dinner.
The Corner Room - This bar serves light fare only.
Late night fare is available from room service.
If you have requests for specific accessibility needs, please note them at check-out when you book your room.
- Accessible bathroom
- In-room accessibility
Nearby Things to Do
Recreational amenities at the hotel include an outdoor pool.
Hotel Policies
You need to know
Extra-person charges may apply and vary depending on property policy.
Government-issued photo identification and a credit card or cash deposit are required at check-in for incidental charges.
Special requests are subject to availability upon check-in and may incur additional charges. Special requests cannot be guaranteed.
No pets or service animals allowed
Children and extra beds
- Children are welcome.
- Kids stay free! Children 12 years old and younger stay free when using existing bedding.
- Rollaway/extra beds are available.
- Cribs (infant beds) are available.
Minimum check-in age is 18
Payment types
We should mention
Children 12 years old and younger stay free when occupying the parent or guardian's room, using existing bedding. No pets and no service animals are allowed at this property.
Hotel Name
- Hotel Sangam
- Hotel Sangam Madurai
- Sangam Hotel
- Sangam Madurai
- Sangam Hotel Madurai
- No pets or service animals allowed


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Paycheck Fairness Act has no place for merit
Chapman University Dean Tom Campbell's column about the "Paycheck Fairness Act" intrigued me, and I agree with him that the Act is very unfair ["'Paycheck Fairness' Act anything but," Opinion, April 27]. He says Section 8 "would have allowed the federal government to force employers to list their employees by sex, race and national origin and report their wages accordingly. Companies that have contracts with the federal government already have to collect such data."
I worked for one of those companies as a manager. It was difficult to truly reward employees based on merit, even though we had annual merit and salary reviews. Each group of employees (those listed above) whose wages were reported to the federal government had to fit a bell curve, regardless of performance. Over the years, I saw a minority employee get a higher rating and salary increase than deserved by performance, in order to get that minority group on the curve. While it helped that individual get a larger raise, it also took a larger raise away from an employee who deserved it.
How do you think that affected employee morale?
I worked with many very bright people. Many who, after having been at the company a few years, realized how the system worked. They did their jobs and met their schedules because they knew that how they performed only played a small part in how they were compensated or promoted. They knew that as long as they did what they were asked to do, within the time-frame required, they would receive a modest salary increase.
They also knew that if they worked harder and saved the company hundreds of thousands of dollars, their reward might be a certificate and a small bonus, but their salary increase would be similar to that same small one they got the year before. Their incentive gone, they would work a 40-hour work week, completing their tasks on time and within budget.
They could have done so much and saved the company and the government thousands of dollars (our tax dollars), if they were motivated. Campbell is right.
The Paycheck Fairness Act is not fair.
Frank Wissel
Huntington Beach
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Check in from 14h / Check out prior to 11h
Park Inn Doncaster: Find photos, reviews, information, amenities and compare prices for 3 stars hotels in Doncaster, United Kingdom.
Contemporary in its design, Park Inn Doncaster is situated in a well-known area of Doncaster. It also provides meeting rooms, an express check-in and check-out feature and 24-hour room service.
Hotel description
The hotel offers a dry cleaning service, a 24-hour reception and luggage storage. A laundry service, a wake-up service and laundry facilities are also provided.
Rooms at Park Inn Doncaster are contemporary and feature cable/satellite channels and tea and coffee making facilities.
The hotel provides breakfast every morning, and has a bar where guests can relax with a drink. There is also the added advantage of an in-house restaurant.
For guests who enjoy making the most of local dining options, there is a good selection right on the door step. It is also an easy drive from Sheffield and Rotherham.
Hotel features
Room Service, Restaurant, Pet Friendly, Bar / Lounge, Air Conditioned, Non-Smoking Rooms, Cable / Satellite TV, Coffee / Tea Maker, Hair Dryer, TV, Shower
Elevator / Lift, 24 Hour Reception, Dry Cleaning, Wake-up Service, Meeting Rooms, Laundry service, Photocopier, Luggage Storage, Express Check-In/Check-Out, Self Laundry
Internet Connection (wireless)
Availability and Prices
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Room Type
Per room
Per night
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Bernard Keninger
Funeral services for Mr. Bernard Keninger, 88, of Spencer, will be held at 11 a.m. Monday, June 20, 2011, at Sacred Heart Catholic Church in Spencer. Rev. William Schreiber will officiate the 11 a.m. service. A flag presentation conducted by the American Legion Glen Pedersen Post No. 1 of Spencer will follow the funeral service.
Visitation will begin after 3 p.m. Sunday, with the family present from 5-7 p.m. Sunday evening at Sacred Heart Catholic Church in Spencer.
There will be a vigil service at 4:30 p.m. Sunday at Sacred Heart Catholic Church.
Interment will take place at a later date at St. Mary's Catholic Cemetery in Ackley.
Mr. Keninger passed away Thursday, June 16, 2011, at St. Luke Lutheran Home in Spencer.
Warner Funeral Home in Spencer is in charge of arrangements.