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Mannkind Corp. (MKND) Q2 2010 Earnings Call August 2, 2010 9:00 AM ET
Alfred Mann - Chairman of the Board, Chief Executive Officer
Hakan Edstrom - President, Chief Operating Officer, Director
Matthew Pfeffer - Chief Financial Officer, Corporate Vice President
Peter Richardson - Corporate Vice President, Chief Scientific Officer
Simos Simeonidis - Rodman & Renshaw Llc
Steve Byrne - Bank of America
Tom Russo - Baird
Michael Tong - Wells Fargo Securities, Llc
John Newman - Oppenheimer
Jon Lecroy - Hapoalim
Doug Dieter - Imperial Capital
Ladies and gentlemen, thank you for standing by. Welcome to the Mannkind Corporation's second quarter 2010 conference call. At this time all participants are in a listen-only mode. Later instructions will be given for the question-and-answer session. (Operator Instructions)
Joining us today from Mannkind are Chairman and CEO, Alfred Mann; President and COO, Hakan Edstrom; Chief Financial Officer, Matthew Pfeffer; and Chief Scientific Officer, Dr. Peter Richardson.
I would now like to turn the call over to Matthew Pfeffer, Chief Financial Officer of Mannkind Corporation. Please go ahead.
Matthew Pfeffer
Good morning and thank you for participating in today's call. I will summarize our financial results for the second quarter of 2010 as reported earlier today. Next, Hakan and Peter will provide an update on key events and finally Al will comment on the current situation and our outlook going forward. We'll then open up the call to your questions.
Before we proceed further, please note that comments made during this call will include forward-looking statements within the meaning of federal securities laws. It is possible that the actual results could differ from these stated expectations. For factors which could cause actual results to differ from expectations, please refer to the reports filed by the company with the Securities and Exchange Commission, under the Securities and Exchange Act of 1934.
This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 2, 2010. Mannkind's management undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.
Let us start with the financials. For the second quarter of 2010, total operating expenses were $37.4 million compared to $53.4 million for the second quarter of 2009, and $40.6 million for the first quarter of 2010. R&D expenses were at $26.2 million for the second quarter of 2010, compared with $39.8 million for the second quarter of 2009 and $30.5 million for the first quarter of 2010.
The decrease in R&D expenses for the second quarter of 2010 compared to the same quarter in 2009 was primarily due to decreased costs associated with the clinical development of AFREZZA, as we filed our NDA in March of 2009. The decrease in R&D expenses this quarter from last quarter was primarily due to timing of insulin purchases.
General and administrative expenses were $11.2 million for the second quarter of 2010, compared to $13.5 million for the second quarter of 2009, and $10.1 million for the first quarter of 2010. The net loss applicable to common stockholders for the second quarter of 2010 was $42.3 million or $0.37 per share, compared with a net loss applicable to common stockholders of $55.6 million or $0.54 per share for the second quarter of 2009.
Our cash, cash equivalents and marketable securities at the end of the quarter totaled $30.8 million. Our cash in hand and remaining credit facility from Al amounted to $138.8 million as of June 30, 2010. Our cash burn in the quarter, again slightly decreased with $37.8 million spent in Q2 compared to $41 million in Q1. With our cash-on-hand and the amount still available under the credit facility from Al, we believe we'll be able to fund our operations through the first quarter of 2011.
We continue to asses our operational plan for the balance of 2010, in order to find ways of extending our cash runway further into 2011.
With that I would now like to turn the call over to Hakan Edstrom. Hakan?
Hakan Edstrom
Thank you Matt. Good morning. Well, as you can imagine, the time between the receipt of the complete response letter in March and the end of the second quarter's been a very busy time for our organization. Not only did we digest the information provided in CRL, but we prepared for and had the meeting with the FDA on June '09, and then addressed the issues put forward by the FDA in our response. That was submitted to the FDA on June 29, and as you know our submission was accepted by the FDA and given a December 29, 2010 PDUFA date.
Our clinical, regulatory, CMC and manufacturing staff have done an outstanding job on analyzing the issue, addressing the outstanding questions and putting together our responses into an amended NDA.
The June 9th meeting with the FDA was an important milestone for us. It provided us the opportunity to better understand the issues that was raised, seek clarification and provide further insights into our NDA. Leaving the meeting with the FDA, our team was so pleased and motivated and encouraged that we were able to respond to the FDA in a timely manner and fortunate, from our extensive database we had most of the answers either already available or almost complete.
The fact that the amended NDA was classified as a Class 2 resubmission with a six-month review time put us right where we had hoped, that would be at this point, potentially gaining approval of AFREZZA, including the next generation inhaler at the end of 2010.
We actually may not have reached this point using our initial pathway of approval, first with the MedTone based version, followed by supplemental NDA to seek approval over the next generation device. With the new pathway, we may have achieved this result with more certainty. We will certainly be working closely with the FDA going forward, diligently responding to questions or providing supplemental information as necessary, in order to complete this final stage of review.
While I obviously will be cautious regarding comments on our partnership discussion, I can say that the discussions have already commenced, following the acceptance of the amended NDA and that several new entrants, including both global and regional players have also emerged. While we still favor a global agreement, a number of regional players are demonstrating significant interest.
I believe that the CRL and the acceptance of the amended NDA were helpful in promoting resumption of partnership discussions, since the issues are now well defined. Whether it will be enough to consummate the deal prior to approval with acceptable economics [ph] remains to be seen; however, the interest is certainly there. It's clear that AFREZZA will be filing a full unmet need in diabetes care by offering comparable HbA1c control to existing insulin therapy, but with significant benefits regarding postprandial glucose excursion, fasting glucose control, hyperglycemia and weight gains.
Well, with that quick overview, I'm going to ask Peter to give you an even greater insight into the June 9 meeting with FDA and the activity in preparation for that meeting. Peter, please.
Peter Richardson
Thank you Hakan and good morning. As Hakan has indicated, the past quarter has indeed bee a very busy time to the scientific and regulatory team at Mannkind, as we successfully filed our response to the questions raised by the FDA in the complete response letter.
To remind you, there were three substantive areas for which the agency raised questions; clinical utility, or where does the project and the product fit into the therapeutic armamentarium with patients with diabetes; the assay methodology used in our study to demonstrate bio equivalency of the inhaler used in our pivotal clinical studies and that to me marketed; and finally, technical aspects of the requirements of the device, such as how often is it changed and how we mark the amount of drug and identify [ph] each cartridge.
As we indicated to you in our previous updates, we are confident that we will be able to address these on the basis of data we already had available, or in the process of generating as part of our previously agreed development of our next generation device, formerly known internally as Dreamboat.
We were able to have a very helpful and productive discussion in the meeting with the agency on June 9, during which we were able to establish that the data would be sufficient for them to resume the review, based upon the additional clinical data from Study 117. We also discussed our study comparing the original inhaler to our new next generation inhaler, demonstrating bioequivalence, using both an ElectroChemiLuminescence assay and Radioimmunoassay.
We're able to show the agency that since this is a systemic peptide [ph], we can make absolute measurements in venous blood and compare them directly in subjects with a range of doses. This is done my maintaining the delivery of the same amount of powder in the range that it is absorbed, whilst reducing the amount that's not absorbed, thus reducing the total amount of powder required in each cartage by 33%. This of course is reassuring in terms of safety and tolerability.
Indeed, the data from our studies looking in detail at the airway reactions with powder, show further reduction in the small pulmonary function changes we've earlier described with the original inhaler. Studies of the performance of the new inhaler in the clinic showed that it can be safely used by patients with no formal training, and that by supplying replacement inhalers every two weeks, there is no need for washing. In addition, we were able to justify [ph] to the FDA that we color code each cartridge pen and mark it with the name AFREZZA and the dose.
Because we had all of these data in hand, apart from the further assay of the samples collected on bioequivalence study, we were able to expedite the preparations for resubmission following the meeting, and filed a fully electronic submission on June 29. Subsequently the agency confirmed and accepted the resubmission, considering this a complete response, this category II, with a PDUFA date of December 29 this year.
I'm delighted with my team's performance in responding so rapidly to the questions and feel that we have a strong set of answers. Furthermore, I'm pleased that we are now on course for the next generation device, which offers such significant benefits.
The new device in the studies are able to address the technical aspects with the complete response, it's clear that this evolution is the optimal approach of bringing our therapy to market in the most effective way and the shortest possible timeframe. In order to do this, we've in essence simplified the old device to its very basics and have not changed in any way the powder formulation or the amount of fine particles absorbed.
Because there has been considerable interest in bioequivalence, I will go over in some detail the results of these studies, showing that we have met the FDA established definitions, using two well validated assays as agreed with the agency. Study 142 has demonstrated the inhalation system used in Phase III trials and generation two inhalation systems to be bio-equivalent.
Bioequivalence is key to linking the pivotal clinical data from the MedTone inhalation system to the to be marketed generation two inhalation system. The study followed the same vision principles that were used to the previous bioequivalent study between the clinical Phase III MedTone inhaler Model C and the previously to be marketed MedTone inhaler Model D, as submitted in the original NDA.
The gen 2 inhalation system delivers the same fine particle doses in the MedTone C inhalation system but with a lower cartridge fill, due to better degeneration [ph] of the powder and better cartridge emptying. The bioequivalence study, MKC TI 142, used the ElectroChemiLuminescence assay and a fully validated radioimmunoassay , thereby meeting all of the requirements of the bioanalytical assays used in bioequivalent studies.
AFREZZA comprises regular human insulin, absorbed on to carrier particles composed of fumaryl diketopiperazine, FDKP. By equivalence, the two inhalation systems measuring insulin levels ensures that the efficacy will be the same, while equivalent exposure measuring the excipient FDKP, ensures that the fine particle exposure to the lung is the same, therefore showing the same systemic exposure in insulin to the two inhalation systems is key to linking the efficacy data. And furthermore, demonstrating bioequivalence in insulin and the equivalent to FDKP exposure combined, is key to linking permanent safety data from the extensive MedTone C Phase III program to data collected from the studies using the two marketed generation two inhalation systems.
In summary, as this inhalation system is designed for the delivery of the systematically active drug, our development approach for the generation two inhalation system has been to match all performance characteristic that could affect the systemic exposure. As we can likely asses the systemically active levels of insulin and the excipient FDKP in the circulation, we've been able to develop a product that is bioequivalent to the one used in all of our Phase III clinical studies.
The primary objective of this trial is to show that the calculated confidence interval for the ratio of the average log transformed insulin area under the curve zero to 120 and Cmax for the 20 unit cartridge using the generation 2C [ph] inhaler, and the 30 unit cartridge using the MedTone inhaler, fell between the FDA standard limits of 0.8 and 1.25. Insulin exposure was evaluated throughout the study by comparing AUC 0-120 and Cmax determined from the C-peptide corrected insulin concentration.
The secondary object of this study, was to show that the calculated confidence for the ratio of the average log transformed insulin AUC 0-120 and Cmax for the 20 unit cartridge using the generation 2C inhaler and two 10 unit cartridges using the gen 2 inhaler, fell between the 0.8 and 1.25 range. In addition, confirmatory pharmacokinetic and bioequivalent analysis were conducted using uncorrected or lower insulin levels, and baseline corrected insulin concentrates to all comparisons.
The 90% confidence intervals for the standard bioequivalent parameters, maximum observed serum concentration Cmax, and the area under the serum concentration time curve from 0-120 minutes post those or AUC 0-120 ratios, fell entirely within the required 80 –to 125% interval.
The ratio of the area under the curve is actually 1.06, with confidence limits of 0.981 to1.145, and for Cmax was 1.082 with confidence margins of 0.992 to 1.180. Similar results were also seen with the required variability and with the RIA and in each of the secondary analysis. Further details of these studies will be available on our website shortly following this call.
It's very gratifying that the data clearly indicates that in our in vitro studies and our initial design confirmation studies are conformed in this very carefully conducted bioequivalent study.
In addition to these important data, we've been able to present the results from our recently completed Study 117, which was conducted in patients with Type 1 diabetes, where we aim to show non-inferiority in HbA1c, whilst reducing hyperglycemia using the dosing regimen.
We announced these results a couple of months ago. Although not a long [ph] study, this is a definitive study which was carefully conducted in several expert centers in the United States. The power is appropriate for the question we asked, it's over 90%, and the duration is sufficient to meaningfully [ph] add changes in HbA1c.
We met the primary end point and non-inferiority HbA1c is demonstrated. High precaution patients reached A1c levels of less than 6.5%, and significantly lower levels of fasting glucose were reached in the AFREZZA treatment patients, even the doses of background insulin was similar in both groups.
Postprandial hyperglycemia excursions were significantly reduced at one hour, two hour and was measured overall in the meal challenges, and importantly significantly lower rates of hyperglycemia were recorded in AFREZZA treated patients, independent of their trial A1c level at end point.
Although a matter for review by the agency, we believe this data will be helpful in further establishing the utility of AFREZZA, as an option for physicians looking to better manage their patients with diabetes and can provide important benefits, not only in terms of glycolic targets, but doing so more safely in insulin regimens used widely today.
Now, let me turn the call over to Al Mann, who will provide better color on some of these filings. Al.
Alfred Mann
Thank you Peter and good morning ladies and gentlemen. This past quarter was momentous for Mannkind. We just received a complete response letter in March raising several questions to be resolved before approval.
The CRL invited us to request a meeting with the agency, that was ultimately scheduled for June 9. Our objective in that meeting was to gain clarity on the path to approval of AFREZZA. The meeting with the FDA was very positive and we believe we have addressed all the questions raised in the CRL and that we're now on a path to approval of AFREZZA.
We told you we would file our amended NDA before the end of July. We actually completed preparation and submitted our response early on June 29. This document incorporated additional data from Studies 117 and 159, the data package from the studies related to the protocol for our next generation inhaler and responses to the several other questions raised in the CRL.
More importantly, the FDA accepted that filing as a Class II complete response submission and set a PDUFA date of December 29. The agency has not required any further studies. There are just a few subjects to review in the file of only about 19,000 pages, compared to 521,000 in the original NDA. We believe that our resubmission addresses the CRL in its entirety and we look forward to working with the FDA for timely approval.
That said, we cannot predict what action the agency will take or whether the action will come before or after the PDUFA date. Given the enormity of issues before the FDA, we are very encouraged that the agency has moved forward so expeditiously and constructively with the AFREZZA resubmission.
The PDUFA schedule is more or less inline with our earlier expected approval for the commercial product using the next generation inhaler, one that we have been proceeding along path and involved approval of AFREZZA using the MedTone device, followed by a supplemental NDA just seeking approval of the next generation device. Thus we have seen no direct impact on our overall regulatory timeline or commercial launch.
We appreciate our relationship and the collaboration with the FDA, and now we are looking forward to launching AFREZZA, what today is a fully met need in diabetes therapy. Our extensive clinical program has demonstrated that AFREZZA significantly improves postprandial excursion, lower type of ischemic incidents, lower fasting glucose, lower weight gain -- probably it's weight neutral and mimics normal curtailment of gluconeogenesis.
Moreover, we have carefully evaluated all adverse events and have presented to the agency an extensive safety package updating the safety experience, and showing no pulmonary damage or clinically significant pulmonary effect, no cardiovascular impact and no indication of any cancer risk. The only adverse effect likely associated with AFREZZA, is mild to moderate coughing in early use with some patients, because people are not accustomed to the feel of inhaling any powder, not just AFREZZA. This effect moderates with use and less than 3% of patients find it objectionable enough to discontinue.
Our study 117, clearly demonstrated the benefits of AFREZZA. Actually, the data is very persuasive and emphasizes the need and the opportunity for better prandial insulin. The FDA has accepted study 117 for a detailed review, and it appears that this study resolves any concern raised by the statistical analysis of study 009.
We have shown at present the non-inferior in reducing HbA1C, compared to the very best prandial insulins available today, and also that it provides many other very important advantages over all current insulins.
We believe these other advantages, even with only comparable effects on HbA1c, will likely propel AFREZZA to become a major antiglycemic drug, but AFREZZA is really much more than non-inferior in HbA1c and we see a great opportunity to get back some trials corrected to demonstrate even greater benefits that are possible with AFREZZA. We will therefore be turning our attention to clinical studies that will show the unique and important advantage of this therapy.
We want to conduct several new trials to confirm in additional patient populations, that without complex dose titration, AFREZZA can provide potentially excellent HbA1Cs as well as superior postprandial glucose control, and lowering fats and glucose levels with weight neutrality, and almost no risk of hypoglycemia from this drug. I believe we'll be able to demonstrate that with AFREZZA, a much larger percentage of patients can reach HbA1c below6.5%. Of course, that is just my projection and new trials that we've directed to support these predictions.
I am confident we will be able to provide a vision into the future, in which therapy for Type 1 diabetes will be simpler and more convenient using AFREZZA, than with rapid analyze and will enable most patients to safely achieve much lower HbA1cs. I also look forward to trials of AFREZZA along with a basal pump or with better basal insulins are expected to become available in three to four years, so that we can further demonstrate the superior advocacy and effectiveness of AFREZZA.
For Type 2 patients, the path is even simpler. What we saw on study 119 and other supporting studies, that there is really no need for titration for meals with carbohydrate content from zero all the way to 150 grams. For more grandiose meal or for meals that digest very slowly, a second dose of AFREZZA maybe taken at the end of the meal and that's probably all that's needed to yield post-prandial excursion within the ADA's target range and also it will enable better HbA1C.
The important question for Type 2 is at what point in disease progressions should AFREZZA be started. This query is all the more relevant given the recent concerns about Avandia and possibly entire class of TZDs, as well as side effects and safety concerns with the other antiglycemic drug. After all, insulin is nature's primary antiglycemic drug, but which class of influence should be the first influence.
Loss of prandial control begins many years before the loss of basal control. Lantus has become so successful as the first insulin used in Type 2 diabetes is really because of the problems with the today's prandial insulin, and this advantage has been effectively marketed by sanofi-aventis, but AFREZZA does not have the deficiency of excessive persistence and hyper insulin anemia seen with today's prandial insulin; then there are other advantages as well. I predict that with little of any titration in early Type 2, AFREZZA will prove to be very effective producing low HbA1Cs, as well as better postprandial level and with a very low risk of hypo.
We must not construct studies that I believe should go far in demonstrating these benefits and distinguishing AFREZZA as a major tool in glycemic therapy, but those studies are for the future and now we need to concentrate on what we have established, and our priority must be to gain approval with the data now available.
We will continue working closely with the FDA to bring AFREZZA to the market, using an enormous body of data that's already been compiled. Based on this data, I believe AFREZZA will fill, what today is the poorly met need and the later trial would be directed towards expanding the label with new data.
Now that we have much more clarity regarding the regulatory path, we are moving forward in signing the commercial launch. Toward this end, a partnership is surely the paramount concern for most of you on this call. All I can say now is that we have just begun to resume launch discussion, with a number of leading partner contenders to commercialize AFREZZA.
In addition, as Hakan said, some new contenders have vested interest in exploring the AFREZZA opportunity. We are considering creating a formal process in order to manage the discussion with multiple parties. We cannot say more about partnership talks at this time, but we will certainly announce any significant development when appropriate.
I am enthused that the data I am seeing and the positive progress with the FDA and at the interest from our potential partners. I must say that I personally am more confident than ever of the success of AFREZZA. I look forward to the excitement of the launch and seeing how AFREZZA will improve diabetes therapy.
Thank you all for joining us today. We now like to open up the call for your questions. Operator?
Question-and-Answer Session
Thank you. (Operator Instructions) Our first question is from Simos Simeonidis from Rodman & Renshaw. Go-ahead, your line is open.
Simos Simeonidis - Rodman & Renshaw Llc
Could you tell us if you received the minutes from your meeting with the FDA, and if so if you've been able to share them with your potential partners?
Alfred Mann
We have not received the minutes yet from the FDA.
Simos Simeonidis - Rodman & Renshaw Llc
Okay. In terms of your discussions on the REMS program with the agency, what is the latest update or status of these discussions?
Peter Richard
Yes, Simos, I think that we are going to get it before in terms of the REMS discussion. We've had some feedback and discussion in the original review and complete the small slider [ph]; there were no significant changes to that. We submitted again our proposal for the REMS program, which has not significantly changed from that which we had previously and we anticipate that there will be further discussion towards the end of this cycle, all of that is (inaudible).
Simos Simeonidis - Rodman & Renshaw Llc
Okay, final question for Matt. It seems like you have, you spent another close to $40 million this quarter and it seems that you have about three more quarters to go and obviously a lot of people are concerned about dilution. Obviously if you have a partnership before that that can possibly alleviate those worries, but is there a possibility where Al could extend his line of credit, instead of having to raise capital in the market?
Matt Pfeffer
Well I'm not sure if that's a question for me, but it's certainly always a possibility. We've been pretty open that our first choice would always be a partnership, but the timing of that is obviously uncertain and we don't want to leave ourselves in a position where we might be viewed as over barrel so to speak with the partner. So we are evaluating a lot of different options and that's certainly the one of the ones we are evaluating.
Simos Simeonidis - Rodman & Renshaw Llc
Okay, thank you very much.
And our next question is from Steve Byrne with Bank of America. Go ahead your line is open.
Steve Byrne - Bank of America
Hi. I was wondering if in your meeting with the FDA whether there was any discussion about an outcome [ph]. Do you think that it's any more or less likely than your views previously?
Alfred Mann
There was no specific discussion about an outcome in the meeting at all. As I'd indicated to you previously, the agency had been cleared in the previous review cycle and quite early on, but in line with the requirements in the answer committee, and we've seen nothing to indicate that has changed, but at this point the agency will of course reevaluate and look at that. From our point of view, we're going to be well prepared should there be (inaudible) committee and actually see this as a very positive opportunity for advancing the data, but at this point there is no reason to believe that there will be one.
Steve Byrne - Bank of America
And Peter, the bioequivalence data that you discussed earlier, will those be available in any form to us?
Peter Richardson
As I said, we will probably today have (inaudible) verbally update, I realize it's always difficult for you to transcribe those numbers. The message around the bioequivalence looks like a very robust package and I think when you see the curves, you will see the remarkable overlay between the MedTone device and the single and the two cartridges of the new device. That's the best set of data that we can bring up.
Steve Byrne - Bank of America
And just one last one from me, is the manufacturer of the Dreamboat device required to be inspected and has that been scheduled?
Peter Richardson
We've certainly not heard any indication of that and I wouldn't expect at this point to have an indication on a requirement inspection on – any supplier. The agency does not inspect any supplier.
Steve Byrne - Bank of America
Thank you.
Our next question is from Tom Russo with Baird. Go ahead, your line is open.
Tom Russo – Baird
Good morning. Thanks for taking the question. Could you comment, maybe provide a little bit of additional detail on how firmly and definitively FDA on its side indicated concurrence with switching the device and seemingly the dose now and not after approval of their device that was used in pivotal trials, and then maybe what divisions the FDA did or did not concur with that approach?
Peter Richardson
I think if the agency hadn't concurred, we wouldn't have sent in the submission. Clearly, what we are trying to talk about here is that we have an unusual situation of an inhaled drug (inaudible) and that was the discussion at the agency in terms of the ability to clearly demonstrate the speculation of the active drug and also the carrier.
The clear bioequivalence that we are able to show, I think also in terms of that is one of the things that's a very important part of doing that. This will be subject to full review by the agency and normally inhale products are more of a challenge initially to get any success or favorability [ph] at all, it's one of the things you try to avoid or it is minimal. And it's also novel as you are looking at what the action of the drug is in the lung, the site of action of the systemic prevail of the peptide which is very good. So we had a very productive discussion with the agency around that.
I think the major thing from their point of view, is that we have not changed the formulation in any way. It's exactly the same powder, and what we've done, as I stated was, just make the device more efficient in reducing the amount of new powder that doesn't contribute to the efficacy, and not which is not inhaled, but is actually left in the cartridge or deposited in the mouth. That actually is the reason that we can take this approach and we made absolutely no change to the formulation.
Tom Russo – Baird
Okay, and then regarding the comments about considering regional partnership or that there is interest from regional players, should we assume that that would be U.S. only or is there in some way -- is the current status with FDA in some way relevant to regional players outside the US?
Alfred Mann
Actually, we have been approached by both regional players from within the U.S and from certainly, a number of other parts of the world, so it's not restricted just to the US. The US approval usually is a critical component of those partnership discussions as well, but the interest is coming in from several parts of the world.
Tom Russo – Baird
Okay. And then lastly, you made a comment in the press release about initiating installation and validation of equipment for the new device. Can you give some additional color on that and what work is left to be done and what regulatory steps are left to be done with regard to the equipment for the new device?
Alfred Mann
Well, when we moved to the so called Dreamboat inhaler, the filling systems for that is of course quite different, and of course all of the packaging is different, so that we have spent this past year designing, working with our supplier, developing the system and the first machine is to be delivered, it was supposed to be delivered about a week or two ago, but it's now scheduled I think for either this week or next week to be delivered and installed.
Our team is over – it's being built in Germany, they are over in Germany now doing testing on it and that will be installed momentarily. And when it's installed, then it has to be validated. It's not clear whether the agency will feel that they need to do another inspection, but that's always a possibility.
Tom Russo – Baird
And aside from the inspection of the physical site, can you comment on what type of a regulatory change it is; just simply as a process change?
Alfred Mann
The process change is part of the CMC package.
Peter Richardson
And I hope it's not a process change, this is purely selling and packaging. Actually the filling principal and the machine design is not exactly the same. It's not much [ph] reduced in the eight clinical matches and the productions that we used for the Dreamboat device, and that's important in terms of the processing of the actual insulin formulation remains exactly the same. This is dose [ph] technology.
Tom Russo – Baird
Okay. Thanks.
Alfred Mann
The powder itself is unchanged. It's just how you fill it.
Our next question is from Michael Tong with Wells Fargo. Go ahead, your line is open.
Michael Tong - Wells Fargo Securities, Llc
Hi. Just a quick follow up on the installation of the new equipment. Is there any validation data that you need to supply to the FDA and how quickly can you do that, given the timing of the scheduled PDUFA date.
Peter Richardson
In terms of specifics there, it's really that equipment as we scale up and produce the commercial batches of that, and that would be a requirement and the timing at which we do that with the agency is subject to discussion. You know that we can get performance in terms of the cartridges and the device that's there, and that's really scale up type, all the activity in terms of bringing that equipment in, rather than putting in a new process when we change it.
Michael Tong - Wells Fargo Securities, Llc
Great. Thank you.
Your next question is from John Newman with Oppenheimer. Go ahead, your line is open.
John Newman – Oppenheimer
Hi guys. Just had a couple of questions. The first one is, it seems like a month or so ago, you had raised the point that there was some sort of a Hemoglobin A1c issue that was raised by the FDA regarding the 009 trial. Just wonder if you could expand upon that and give us a little color there.
Also for the 117 study, it also seemed like the enrollment target that you originally had was reduced, and I am also just wondering, given the fact that the efficacy from the control arm, they are seeing maybe a little different than what we would expect. I am just wondering how you're positioning the results with the FDA? Thanks.
Alfred Mann
Okay. John, to take the 009, I think this is one that we discussed at length. You know that the margin of the upper bound of the confidence interval is actually a (inaudible) which is right at the edge on non-inferiority and I think that the discussion that we had around 009 has been although the meaningful analysis and there's (inaudible) non-inferiority with that.
We wanted in terms of 117 to look and we could (inaudible). If you look at the results of 117, that's true. The numbers in that study alone which we had originally projected, that was done with the original device and we stopped that study, when we stopped producing the new device and decided to make that change over on to the new device.
We looked at the power of that study in order to being able to address these questions and looked at that in light of whether we have sufficient power, and as I said we had 90% power to address that, which is really what our best physicians say and more than adequate in terms of questions that we had.
Your question around the control arm, I actually would find it difficult because it's actually in keeping with what we see and a lot of other registration types that is. (inaudible) HbA1cs that we recently well controlled patients that were going into the study. So we wouldn't expect to see a really marked improvements in the HbA1cs in either group. They both follow the same pattern in the end and we are clearly showing non-inferiority there. So I think it's entirely consistent with what you would expect in this study, increasing the time [ph].
John Newman – Oppenheimer
Alfred Mann
I think the important things are we are seeing first hand [ph] and I think it's very, very important that we are getting more patients down to last 6.5 [ph], and we are doing that without new improvements in hyperglycemia. That's an important piece, I think I'm really sure what we've been talking about in terms of what you can do with an improved prandial insulin.
John Newman – Oppenheimer
Correct. And then just a quick question for Matt. I know you've already had one question on financing, but just curious if you can give us any sort of guidance or sense as to how we might want to think about just the way that Mannkind would address cash needs this year? Would you maybe think about a raise or are you happy with the cash that you currently have on the balance sheet? I know you had a question already about possibly extending the line of credit. Just kind of curious as to how we should think about it?
Matthew Pfeffer
Yeah, I think it's a little pre-mature to answer that question in any definitive way, John, so I don't mean to be evasive. I am happy not just with the cash on the balance sheet, but of course that's backed up by a line of credit that we access on a regular basis and tend to keep our cash on the balance sheet typically around $30 million at the end of every quarter. So it's been a fairly consistent, plus or minus a million here or there.
We have a lot of financing options. I think we are unique in having as many as we do. Al was one of them before, I think that's certainly unique and we are looking at all of them and it's premature to commit one way or the other. We obviously want to feel for how some of these things are going to play out before we come to a conclusion. So we have not made a determination at this point and when we do, we'll tell you about it.
John Newman – Oppenheimer
Okay, thanks.
Our next question is from Jon Lecroy with Hapoalim. Go ahead, your line is open.
Jon Lecroy – Hapoalim
Yeah, thanks for taking my call. I first want to talk on the 117 trial. It was an open label trial and it looks like the patients in the injected insulin arm had much lower fasting level of glucoses implying -- or I'm sorry the other way around, that Technosphere had lower fasting glucose implying they are on more basal insulin. I am wondering what the open label nature of that had maybe to do with that data point.
Peter Richardson
I am sorry, you are just incorrect. They are actually …
Alfred Mann
We seem to be losing Peter. Hello, Peter? Peter, we lost you there for a while. So you may want to repeat what you said.
Peter Richardson
Hi, sorry. (inaudible) exactly the same levels of (inaudible) which is the long acting insulin used in both arms. So the difference that we see are due to differences in the prandial insulin. We've talked about the rationale for that, and the reasons for that which are not entirely clear, but we think there's probably differences in insulin resistance. That's been a very consistent finding that we've seen across all our studies. The open label nature is standard in insulin studies as you know and I think has no impact whatsoever.
Jon Lecroy – Hapoalim
Okay thanks. And then as far as Europe goes, what are your plans on more trials to do European filing and kind of timing on European filing?
Peter Richardson
At the present stage we are looking in terms – are having -- I think that would be a discussion, but we'll absolutely have a potential partner onboard and that would be very helpful to us in terms of that filing. There are no specific requirements of any additional studies required in order for us to do a filing in Europe.
Jon Lecroy – Hapoalim
Okay, thanks.
(Operator Instructions) Our next question is from Doug Dieter with Imperial Capital. Go ahead, your line is open.
Doug Dieter - Imperial Capital
Good morning. Just wanted focus on the discussion with partners and I guess my first question is, what is the primary hiccup right now to get something done with the primary push backs from the best partners?
Alfred Mann
There is really no push backs, Doug. It's just that we were waiting to finalize or to really start serious talks until we got the minutes from the meeting of June 9, which are obviously late from the agency, but we understand that. But given that it's been delayed, we have started the discussions, but we won't get into any real negotiation till after we see the minutes.
Doug Dieter - Imperial Capital
And in terms of your confidence level, I know you're not giving guidance here, but obviously your intent is to get an approval by December. You want to have a partner probably by September-October timeframe. What's your confidence around being able to do so and is it clear from the potential partner side that that's the timeline?
Alfred Mann
No. You know early last year we were told by our partners that they wanted to close the deal in July. So I made a prediction that I'm not going to do that again.
Hakan Edstrom
No. I would also say Doug that as I mentioned in my part of the presentation, that we've had new both global and regional contenders coming into the game, and certainly we want to manage all the discussions in a way to hopefully optimize the financial results of the discussion. So from that point of view, I would not kind of hold ourselves to a specific timeline September-October, but looking for what is the best possible deal that we can accomplish, trying to also bring the newcomer is kind of somewhat in line with people that have been with us for a longer period of time.
Doug Dieter - Imperial Capital
And then finally, just from the liquidity perspective as a follow-up to a prior question, Matt is it safe to assume that the reason why you're not going to comment on additional liquidity is because you're waiting on what the partnership potentially brings to the table?
Alfred Mann
Certainly, one factor.
Matthew Pfeffer
You've taken the words right out of my mouth Al. It's certainly one of the factors but it's not the only one and so we want to make sure we do a thorough evaluation of what our options are before we come to a conclusion.
Doug Dieter - Imperial Capital
Fantastic. Thanks.
Alfred Mann
All right. I'd like to thank all of you for joining us today. We look forward to updating you in our next quarterly call or perhaps sooner. Good day folks.
That does conclude today's conference. Thank you for participating. You may disconnect at this time.
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text:
Hi! I want something like this:
I want to allow guests to post/comment in a specific category and allow them to upload images files. (just like the link). So when they send it, it will post to my admin in the pending (revision) posts, with the title, content, cateogory and images uploaded...
Help! Please!!!!

subset: commoncrawl


text:
Now Foods, Thyroid Energy, Thyroid Support, 90 Veggie Caps
Volume Discount
Buy 2+Save 5%
- You earn loyalty credit for every order you place at iHerb!
- Loyalty credit is equal to 10% of the value of your order, excluding shipping charges.
- Your loyalty credit will be applied towards your next order as soon as your current order has shipped.
- Your loyalty credits are valid for up to 60 days from the date of your last purchase.
This product is already in your Wish List.
View Wish List
This product is now in your Wish List.
Sorry, this product is no longer in stock.
Expiration Date:?Mar 2018Expiration Date
The length of time for the expiration date or "best used before" date depends on the type of product, as well as the brand.
Perishable items (such as flax oils or certain probiotics) generally have shorter expiration dates. Although our warehouse is fully air-conditioned, these more fragile items are put in cold storage (freezer or refrigeration unit) for maximum freshness.
Our receiving department does its best to verify and then enter the correct expiration dates for all incoming products. However, discrepancies do occur from time to time. This being said, the exceptionally high turnover at iHerb ensures that our inventory is among the freshest in the industry.
Shipping Weight:?0.35 lbs (0.16 kg)Shipping WeightThe Shipping Weight includes the product, protective packaging material and the actual shipping box. In addition, the Shipping Weight may be adjusted for the Dimensional Weight (e.g. length, width & height) of a package. It is important to note that certain types of products (e.g. glass containers, liquids, fragile, refrigerated or ice packed) will often require protective packaging material. As such, these products will reflect a higher Shipping Weight compared to the unprotected product.
- Product Code: NOW-03368
- UPC Code: 733739033680
- Package Quantity: 90 Veggie Caps
- Dimensions: 4.375 x 2.375 x 2.375 in, 0.3 lbs (0.14 kg)
|Combo Discount:
|- $1.89
Sorry, this product is no longer in stock.
- Supports Healthy Thyroid Function
- Supports Healthy Metabolism
- GMP Quality Assured
- A Dietary Supplement
NOW Thyroid Energy is a complete nutritional supplement for the support of a healthy thyroid gland. NOW has combined Iodine and Tyrosine, the two integral constituents necessary for the synthesis of thyroid secretions. The minerals Selenium, Zinc and Copper have been added as cofactors needed for normal thyroid function. In addition, NOW Thyroid Energy contains the Ayurvedic herbal extracts from Guggul (Commiphora mukul) and Ashwagandha (Withania somnifera) to complement its nutritional support components.
Suggested Use
As a dietary supplement, take 2 capsules daily, preferably in divided doses.
Other Ingredients
Cellulose (capsule), cellulose powder, magnesium stearate (vegetable source) and silica.
Not manufactured with wheat, gluten, soy, milk, egg, fish, shellfish or tree nut ingredients. Produced in a GMP facility that processes other ingredients containing these allergens.
Caution: For adults only. Consult physician if pregnant/nursing, taking medication, or have a medical condition. Persons with thyroid disorders or those taking warfarin, thyroid medications, L-dopa, SNRIs, MAO inhibitors, or other mood altering medications should seek the advice of a physician before consuming this product. Keep out of reach of children.
Do not eat freshness packet. Keep in bottle.
Store in a cool, dry place after opening. Please recycle.
|Supplement Facts
|Serving Size: 2 Veg Capsules
|Servings Per Container: 45
|Amount Per Serving
|% Daily Value
|Vitamin B-6 (from Pyridoxine HCl)
|2 mg
|Folate (as Folic Acid)
|400 mcg
|Vitamin B-12 (as Methylcobalamin)
|60 mcg
|Iodine (from Potassium Iodide)
|200 mcg
|Zinc (from L-OptiZinc - Zinc L-Methionine Complex)
|25 mg
|Selenium (from L-Selenomethionine)
|50 mcg
|Copper (from Copper Amino Acid Chelate)
|0.8 mg
|L-Tyrosine (Free-Form)
|1 g (1,000 mg)
|Guggul (Commiphora mukul) (Resinous Sap) Standardized Extract (min. 2.5% Guggulsterones)
|75 mg
|Ashwagandha (Withania somnifera) (Root) Standardized Extract (min 2.5% Withanolides)
|50 mg
|† Daily Value not established.
I can't say enough about Thyroid Energy. This is my second bottle and I LOVE IT! I have had hypothyroidism since I was about 25 (I am 30 now) and taking prescription Levothyroxine is a joke. It makes my levels look good on paper, which pleases the doctor, but my symptoms are still pretty bad. This product helps me feel a lot better. I take 2 caps in the morning with Acai supplements and then 1 in the afternoon. If I don't take the Thyroid Energy, I have that "must lay down and take a nap right now" feeling, which I hate! This really helps, I am a firm believer in it! I had to do something when the Levothyroxine wasn't enough! This is a God-send for me! I highly recommend!
It took a little over a week of taking the Thyroid Energy supplements twice a day (the recommended dose) before I noticed any change. It's been over three weeks and I feel like my old self again. Totally rejuvenated! Even my family has noticed the changed. It feels great to be more active instead of being worn-out all the time! A friend had recommended this product to me, even though neither one of us has a thyroid problem, to boost our energy levels. Now I'm the one recommending it to family and friends, it really does seem to work!
So glad i found this!
Posted by 5102815006791168256 on Aug 24, 2016
I am currently taking only 1 cap as I found 2 capsules to be a little too strong. I do feel more energetic! Its a great product with good value.
Posted by EskoVihtori on Aug 22, 2016
It feels good. always I'll take this pill in the morning on an empty stomach, I'll eat later, after 4 hours, this pill to feel good, or at least does not have any bad feelings. It seems that I can get one pill adequately and suitably energy. If I take 2 get more energy. One day is better than the dosage. I have used this for several years. 69 years of age.
Can't keep these down~ :(
Posted by 5141190051018159758 on Aug 17, 2016
Did not feel much a difference....but was honestly unable to keep them down for very long. Feeling of sour stomach and dizziness occurred for me. May try again once every-other day....
new for me
Posted by 4844806052765778434 on Jun 28, 2016
i have tried it for the first time, my energy is better
great for metabolism
Posted by 5245027485894609438 on Jun 17, 2016
I really feel a difference if I take them every day or not. It definitely helps balance my metabolism. It is 100% vegetable which is a great plus for me. Recommended!!


text:
Cooper is out injured with a knee problem and Beale will step into the playmaker role in his 30th Test. Cooper has also been contacted by the Australia Rugby Union after a series of negative Tweets about team morale.
"The (jersey) number might be new but his role within the game won't be," Deans said of Beale in a statement.
" Although his season hasn't been without challenge, Kurtley stepped up with his involvements on the Gold Coast, making a difference when he was on the field.
" He's brought that enthusiasm forward with him since we've been in South Africa, has worked hard on the training track, and is excited about the opportunity ahead. He has good memories from some of his experiences over here," Deans said.
Berrick Barnes will start at fullback and assume the kicking duties, Deans said. Lock Nathan Sharpe, in his 110th Test, continues to captain a side hit hard by injuries.
Sharpe will join former openside flanker George Smith as Australia's most capped forward, and a personal milestone awaits front-rower Benn Robinson, who will be playing his 50th test.
Second rower Kane Douglas has retained his place but Sitaleki Timani's return from a hamstring strain will have to wait after medical staff judged he was not fit enough.
Australia beat the Springboks 26-19 earlier this month in Perth but Deans warned against complacency, especially at the Loftus Versfeld Stadium in Pretoria where they have never won.
"They are proud men, and they don't lose at Loftus very often," Deans said of the Springboks.
"While they are coming off a tour which would have disappointed them, they were in both contests and will feel that they could have won on both occasions.
" That will only spur them on, as will the atmosphere which is always electric for test matches in Pretoria."
Deans is also wary of the Springbok goal - kickers such as inside centre Francois Steyn.
"Discipline is always key, but there's no doubt about its importance when you play South Africa as they always have goal-kickers who can routinely kick goals anywhere on our side of halfway, or even from 60 metres at altitude in Francois's case."
Australia team to face South Africa: 15-Berrick Barnes, 14-Dominic Shipperley, 13-Adam Ashley-Cooper, 12-Pat McCabe, 11-Digby Ioane, 10-Kurtley Beale, 9-Nick Phipps, 8-Radike Samo, 7-Michael Hooper, 6-Dave Dennis, 5-Nathan Sharpe (captain), 4-Kane Douglas, 3-Ben Alexander, 2-Tatafu Polota Nau, 1-Benn Robinson.
Replacements: 16. Saia Fainga'a, 17-James Slipper, 18-Rob Simmons, 19-Scott Higginbotham, 20-Liam Gill, 21-Brett Sheehan, 22-Anthony Fainga'a
- South Africa
- Australia


text:
Sighting Basics
|Case Number
|Log Number
|Date Submitted
|Date of the Event
|I saw a cigar shaped object take off and change into a pink cloud
Sighting Location
|United States
Sighting Specifics
|Viewing Distance
|21-100 Feet
|Sighting Duration
|Object Features
|Object Flight Path
|Straight-line path
|Object Shape
|Weather Factors
Sighting Details
I awoke in my bed and began to open my window shades. The 1st one I opened did not reveal the craft. I opened the 2nd shade and saw a glowing cigar shaped object across the street in the power line field. I was scared and got on the floor and peered over my bed. For some reason I was affraid to move even tho my bedroom door was a few feet behind me . I thought I would be zaped or something. It than began to rise with no sound still amiting the firery aura around it. I watched it go up into a SE direction toward Renton and Lake Washington. As it rose higher into the sky I got up off my knees and went to the window and watched it change into a pnk cloud and then blended into the sky. My mother did not believe me (I was almost 8). She finially did and called a local radio station. They directed her to the local air force base. This would be McCoard Air Force Base near Tacoma. Some men in uniform came to my home and asked me a lot of questions and had me color a picture of the object . Then they carried me into the field. They had machines that they ran over the ground something like a meatal detector. The ground was 3ft hight feild grass was smashed in a big circle, about 15 Ft in diamitor. They asked how big it was. I told them it was about 3 or 4 car lenghts long. They used the cars on the highway for a mesurment i could realte to. My Neighbor came over and wanted to know what was going on. My mother told her that I thought I saw something. She said she saw it too. She saw it land about 4am in the morning. The Airforce guys talked to her and told us something was there, they do not know what but was there for a few hours. They left and the sighting never left me. I knew as a little girl we were not alone and instilled a faith in me of a higher enity. I tried to contact MAFB as an adult and they shut me down and said thye do not keep record of things of this type. I know they do and still have my drawing.
Did You See It? Have a Comment or Question? Discuss it Below.
blog comments powered by Disqus
- There have been 152 other sightings in Seattle
- There were no other sightings in Seattle on or around June 26th 1962
- This sighting has never been favorited.


text:
The Support Forums will be in read-only mode for a scheduled maintenance window on 01 September 2016 14:00 UTC - 20:00 UTC. More information.
exactly what I was looking for...
Simple to install and insert to a Post..
If you want, you can have a look to my USA Travel with the Foto Map...
This basically is a no-brainer install. It works right out of the box.
The only improvement that I could use on my site would be an option to edit/add each images geo-location info directly in the media browser. Otherwise this is exactly what I was looking for.
Really simple to use and yet useful. Probably the easiest way to display geotagged photos on a map. I love it :D
Excellent - works out of the box.
Excellent - I have been looking for this sort of plugin for quite a while. Maybe you could add an option to display the route (from gpx or kml file) ?
You must log in to submit a review. You can also log in or register using the form near the top of this page.


text:
Book your room at Holiday Inn Express & Suites Alpharetta - Windward Parkway
Get an overview of this hotelAlpharetta hotel with complimentary buffet breakfast
Amphitheater: 3.9 mi
This hotel is in Alpharetta, Georgia, 3.9 miles from the Verizon Wireless Amphitheater and 4.7 miles from Northpoint Mall.
Buffet breakfast
Hotel Sierra Alpharetta offers complimentary buffet breakfast. A complimentary shuttle takes guests within 5 miles of this property.
Flat-panel TVs
Guestrooms at Hotel Sierra Alpharetta offer clock radios with MP3 players, beds with pillowtop mattresses, and flat-panel TVs with premium cable channels.Would you like to give us feedback? Share it! Opens in a new window
Holiday Inn Express & Suites Alpharetta - Windward Parkway12505 Cingular Way Alpharetta GA 30004
Hotel Amenities
Hotel Amenities
Hotel Sierra Alpharetta provides complimentary buffet breakfast. A complimentary shuttle takes guests within 5 miles(8 kilometers) of this Alpharetta property (limited availability; contact the property for more information). The business center is open 24 hours a day; complimentary wireless Internet access is available throughout the hotel. This Alpharetta hotel offers fitness equipment, laundry facilities, and a seasonal outdoor pool. Dry cleaning is available, and a gift shop is on site at this smoke-free hotel.
- 24-hour front desk
- Coffee/tea in common areas
- Coffee shop or café
- Free newspapers in lobby
- Free breakfast
- Conference space
- Dry cleaning/laundry service
- Elevator/lift
- Express check-out
- Fitness facilities
- Gift shops or newsstand
- Total number of rooms - 124
- Laundry facilities
- Meeting rooms
- Number of floors - 6
- Free self parking
- Number of restaurants - 1
- Smoke-free property
- Outdoor seasonal pool
- Television in common areas
- Free WiFi
- Multilingual staff
- Safe-deposit box at front desk
- Free area shuttle
- 24-hour business center
- Number of buildings/towers - 1
Family Friendly Amenities
- Family Hotel
- Free Wi-Fi
- Area shuttle (complimentary)
- Laundry facilities
- Refrigerator
- Microwave
Available in all rooms: Free WiFi , Free wired high-speed Internet
Available in some public areas: Free WiFi
Free self parking
Room Amenities
- Flat-panel TV
- Bathrobes
- MP3 docking station
- Air conditioning
- Refrigerator
- Satellite TV service
- Pillowtop mattress
- Blackout drapes/curtains
- In-room climate control (air conditioning)
- Coffee/tea maker
- Free newspaper
- Free toiletries
- Cribs/infant beds available
- Desk
- Hair dryer
- Daily housekeeping
- Iron/ironing board
- Free WiFi
- Free wired high-speed Internet
- Microwave
- Premium bedding
- Premium TV channels
- Shower/tub combination
Where to Eat
Hotel Sierra Alpharetta provides complimentary buffet breakfast, with cereal, fruit, and made-to-order omelets.
The hotel also features Evening Bistrio, offering beer, wine, and appetizers served in a living-room style atmosphere. The bistro is subject to availability.
Nearby Things to Do
Hotel Sierra Alpharetta offers fitness equipment, including cardio equipment and free weights. The outdoor pool is open seasonally.
The recreational activities listed below are available either on site or nearby; fees may apply.
To make requests for specific accessibility needs, complete the "Special or Accessibility Requests" section of "Trip Preferences" when you book your hotel.
- Accessible bathroom
- In-room accessibility
Hotel Policies
Check-in time starts at 3 PM
Minimum check-in age is 21
Check-out time is noon
Payment types
- Pets not allowed
You need to know
Extra-person charges may apply and vary depending on hotel policy.
Government-issued photo identification and a credit card 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 rollaway/extra beds available
Hotel Name
- Holiday Inn Express Alpharetta Windward Parkway
- Holiday Inn Express Windward Parkway
- Holiday Inn Express Windward Parkway Hotel
- Holiday Inn Express Windward Parkway Hotel Alpharetta
- Holiday Inn Express Alpharetta Windward Parkway Hotel
We should mention
Children 18 years old and younger stay free when occupying the parent or guardian's room, using existing bedding.


text:
Paula Patton Opens Up About Finding Happiness After Divorce from Robin Thicke
"I want more joy. I want more happiness."
… More »
"I want more joy. I want more happiness."
… More »
Here's all the movies you don't wanna miss!
… More »
Paula Patton is ready to love again!
… More »
For a good part of last year, Robin Thicke's thirst for his ex Paula Patton was too real, and honestly his attempts to try and win her back (aka his Paula Patton Apology Tour of 2014) were very painful to watch.
Thicke admits that while at the time he thought he was… More »
The gorgeous Paula Patton opened up about her split from first love Robin Thicke for the very first time since filing for divorce in October 2014.
… More »
Looks like Robin Thicke is ready to put his 2014 heartbreak behind him and move forward with new love in 2015!
The "Blurred Lines" crooner reportedly rang in the new year with his 20-year-old girlfriend April Love Geary–the model who showed her booty off on Instagram last month.
… More »
Robin Thicke's new 19-year-old girlfriend definitely isn't shy on social media.
April Rose Geary, Thicke's rumored new love, just showed off her butt on Instagram. Check out the photo below! … More »
It's officially over.
Despite Robin Thicke's many, many attempts to win back his wife, Paula Patton has filed for divorce. According to TMZ, the Baggage Claim actress cites "irreconcilable differences" in the documents and is seeking joint custody of their four-year-old son, Julian.
… More »
Robin Thicke isn't holding anything back in a new deposition, revealing his past Vicodin and alcohol routine.
There's been a legal battle going on between Thicke and Marvin Gaye's family, who continue to claim that "Blurred Lines" is a rip-off of Gaye's song, "Got to Give it Up." Now, it's being reported that in… More »
Paula Patton gave photographers quite the eyeful when she stepped out to have dinner at Craig's restaurant in a very sheer dress, accidentally showing off her nipples when the flashbulbs went off.
… More »
After countless speeches on losing her, too many performances sang about her and an entire flopped album dedicated to her, I'd say it's about time Robin Thicke waves the white flag on his marriage.
And thankfully–for the sake of all of our sanity–he finally has.
The "Blurred Lines" crooner admitted to… More »
It looks like all the buzz around Robin Thicke's creepy ode to his estranged wife, Paula, did nothing to bring him and Paula Patton closer together.
While appearing on Hot 97 for a radio interview, the singer revealed that he hasn't spoked to his wife in months and that his latest album is his way of
publicly… More »
It's a new week, which means Robin Thicke has made yet another attempt at winning back his wife Paula Patton through song.
… More »
Sorry, Robin Thicke.
If you were going for sweet and remorseful, you should probably make another music video for "Get Her Back."
What's wrong with the video, you ask?
… More »
As you've probably heard, Robin Thicke's upcoming album is named Paula as an ode to his estranged wife. Well, the "Blurred Lines" singer has recently released its track list and, unfortunately, the titles are just quite disappointing and lackluster if these songs are indeed his last ditch attempt to get his lost love's attention.
… More »
This guy.
Musician Robin Thicke is reportedly naming his upcoming album, Paula, after his estranged wife, actress Paula Patton. … More »
It looks like Robin Thicke isn't about to stop trying to win Paula Patton back anytime soon… In fact, you can look forward to yet another desperate gesture this weekend.
The "Blurred Lines" singer has written a new song for his ex-wife which he will perform at the Billboard Music Awards on Sunday. More »
Well, so much for trying to win her back.
According to Robin Thicke, he's actually quite content with life despite recently splitting with Paula Patton after almost nine years of marriage.
"We're both doing well. We're both very happy right now — much happier," he tells People. "Everything about this moment… More »
Today will be a rough one for Robin Thicke as he'll be ringing in his 37th birthday all alone for the first time in over 20 years following his split from wife Paula Patton–his high school sweetheart.
But it's not his birthday that has the singer's attention. He's still sending messages to Paula… More »
Robin Thicke has been spotted strolling the streets of New York City over the weekend and whether it's his impending birthday or his newly single existence, something has definitely put a pep back in his step.
Despite continuing to profess his love for Paula Patton since their separation was announced on February 24th, the "Blurred… More »


text:
Q Fence Company - Telford, PA - Phone: (215) 721-9747
Fence contractors in Telford are the professionals who install, remove or repair fences on a contract basis. These contractors have years of experience in installing and repairing Industrial, Commercial and Residential applications. Telford has few of the largest companies that install and repair Automatic Gate Operators and Access Systems. Fence contractors in Telford serve commercial and industrial properties, apartment communities, residential subdivisions and private residences.
By: Lee Ann Rush Those ubiquitous, multi-flavored individual coffee servings sold in plastic pods known as Keurig K-Cups might have been a clever and novel idea at first, but they are quickly becoming an environmental disaster. In 2014, billions of plastic K-Cups were sold; enough to circle the earth more than 10 times! As bad as that sounds, it gets..


text:
Prof. Dolan is joint founder and Director of the UNESCO Child and Family Research Centre and an Academic Director of the M.A. in Family Support Studies. He also contributes to the wider undergraduate and postgraduate degree programmes of the School of Political Science and Sociology as well as supervising Ph.D. candidates and Masters Dissertations in Family Support, Social Work and Community Development.
Dr. John Canavan is joint founder and Associate Director of the Child and Family Research Centre. He has extensive experience in researching and evaluating social intervention programmes in the areas of child and family care, educational disadvantage, and community and local development. He received his PhD from Queens University, Belfast in 2006 and holds an MA in Community Development from NUI, Galway.
Aileen Shaw joined the Child and Family Research Centre as the Manager of Strategic Development in 2007. She has extensive experience in fundraising and nonprofit management.
Emily O'Donnell was appointed to the position of Business Manager of the Child and Family Research Centre in 2008. Emily is responsible for the day to day operational and financial management of the centre.
As a graduate of NUI, Galway, Emily holds a BA in French and Italian, Higher Diploma in Business Studies and a Higher Diploma in Marketing Practice.
Prior to joining the Child and Family Research Centre, Emily worked in a number of business and marketing roles in the financial, education and communications sector.
Gillian is currently the administrator for the Child and Family Research Centre. Since joining the CFRC in 2006, Gillian has provided support to the MA in Family Support Studies and works on a range of event management and operational areas at the Centre. Gillian holds a BA in Business Studies from the GMIT, Galway and a Higher Diploma in Education from NUI, Galway.
Prior to commencing employment at the CFRC, Gillian worked in a number of administrative roles in the Health and Technology sectors.
Bernadine Brady is a Lecturer in the School of Political Science & Sociology and has been a Researcher in the Child and Family Research Centre since 2003. She is an experienced mixed-methods researcher, with particular expertise in relation to children's policy and services. In recent years, Bernadine was lead researcher on evaluations of the Foróige youth citizenship programme and the Big Brothers Big Sisters Programme in Ireland and has previously undertaken studies in relation to children's participation, family welfare conferencing and young carers in the CFRC.
Anne Cassidy is a postdoctoral researcher working on the Mainstreaming and Development Programme with particular responsibility for the Meitheal and Child and Family Networks Evaluation. She is also part of the Centre's UNESCO Youth Research Group. Anne also contributes to the BA in Early Childhood Studies and Practice (Final Year Dissertation Tutor) as well as the BA in Youth and Family Studies (Qualitative Research Methods).
Dr. Nuala Connolly is a postdoctoral researcher in the UNESCO Child and Family Research Centre. Nuala is experienced in multi-method and multi-themed child and youth research, including longitudinal evaluation and field-based action research.
Carmel is a Lecturer and Course Director of the Master Degree in Family Support Studies in the UNESCO Child and Family Research Centre at NUI Galway. Carmel is lead researcher on a number of practice based projects for the HSE and has designed and delivered a number of Family Support training initiatives for managers and practitioners. Carmel has also worked for many years in children and family services as both a practitioner and manager. Carmel's recent publications and conference presentations are in the area of Family Support, child welfare and protection, and wellbeing.
Allyn Fives is a Lecturer in Political Science and Sociology and has carried out research at the UNESCO Child and Family Research Centre since January 2009. His research projects include the RCT evaluation of the Barnardos Wizards of Words (WoW) reading programme, the national study of Young Carers in the Irish Population commissioned by the OMCYA, the evaluation of the Triple P parenting programme delivered by LWPP, and evaluations of the Restorative Practice programme in Tallaght West and the Belong project.
Cormac is the Programme Coordinator of the BA in Youth and Family Studies (GY120), a three-year degree offered by NUI Galway in conjunction with St. Angela's College, Sligo. As well as lecturing on this programme, he also provides inputs to the MA in Community Development, the MA in Family Support and to the Structured Ph.D. Programme at the School of Political Science and Sociology.
Sheila is an Academic Coordinator of the BA Honours Degree in Early Childhood Studies & Practice, delivered through the Adult & Continuing Education department of NUI Galway. Sheila lectures on the programme and supports the lecturing team within the programme. As part of her role with the UNESCO CFRC Sheila has contributed to the MA in Family Support Studies, the MA in Community Development, and to the BA Connect in Childhood Studies.
Danielle Kennan is experienced in applied social science and legal research. Danielle has taught, researched, and published in the field of children's rights and child well-being. She has a particular expertise in the area of a child's right to participate in decision making. She is currently a post-doctoral researcher on the Tusla Development and Mainstreaming Programme supporting prevention, partnership and family support.
Fergal joined the Child and Family Research Centre in September 2009 as Researcher – Service Development and Design. Fergal previously worked in practice with the HSE as a Community Development Worker with responsibility for the development of family support services in North Tipperary, as a Child Protection Social Worker in Galway and as a Social Worker with out of home adolescents as part of the Crisis Intervention Service in Dublin.
Berni Smyth is a part time Lecturer with the UNESCO Child and Family Research Centre, NUI Galway. For a number of years, she has lectured on various post and undergraduate courses including the Masters in Family Support, Masters in Social Work, Masters in Community Development and the BA in Youth and Community Studies.
Berni has a Masters in Family Support (NUI Galway) and has undertaken research into intensive family support and the perceived social support networks of adolescent asylum seekers, refugees and migrants.
Brian Fox has recently joined the Centre as an intern. He is involved in different research-related tasks for the Centre and School of Political Science and Sociology under the supervision of research staff. His is based in ILAS on a three-day from May to August 2015.
Brian has recently completed the Mature Access Course in NUI Galway. He is planning to start an Undergraduate Course in Sociology and Political Science in September this year.
Iwona O'Donoghue provides research assistance to Professor Pat Dolan, UNESCO Chair in Children, Youth and Civic Engagement. Since joining the CFRC in 2009, Iwona has been responsible for the administration, coordination and management of activities relating to the UNESCO Chair.
In addition to her work with the UNESCO Chair, Iwona assists in the delivery and coordination of centre projects and events.
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UNESCO Child and Family Research Centre, School of Political Science & Sociology, Institute for Lifecourse and Society, Dangan, Upper Newcastle Road,
National University of Ireland Galway, Ireland. Tel: +353 91 495398 - Fax +353 91 495582


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One local fitness center wants to make sure kids stay active this summer.
The Fieldhouse is offering its summer camp to kids, between ages six and 14. It starts May 24th and goes through the beginning of September.
Director of Operations, Jim Fraunfelter, says he doesn't want kids to just sit on the couch and play video games for three months.
"They have to walk a mile. A mile means not in four minutes. We do it different times of the day. They swim every day. We've play basketball, dodgeball, football, volleyball, and just anything. The biggest thing we can do is we're weather-proof. If it's raining outside, we can come indoors and do the same thing we can do outdoors, " says Fraunfelter.
The summer camp wants to teach kids about the three r's...respect, responsibility, and recreation.
"If we can get those three r's, the hopefully, that young man or young lady can go a long way in life, " says Fraunfelter.
If you're interested in registering your child for the summer camp, contact the Fieldhouse at 740-454-2224.


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17 years of experience
Accepting new patients
Video profile
2821 E President George Bush Hwy
Richardson, TX 75082 Phone number & directions
Patient Reviews
Patient Reviews ? Write a Review
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I highly recommend Dr. Norton. She's knowledgable, spends time with you & friendly, as an added bonus. You sometimes have to wait a little past your appointment time, but only because she's busy and takes her time with her patients. Well worth it.
I trust her so much.. she deliver my baby girl .. the best obgyn I ever know. . Spend so much time listen and speak ..
She is hardly available. Throughout pregnancy I saw her only once. All the appointments were with the nurse. Also she cancels appointments and you have to reschedule your work days.
Love Dr Norton!! Best Gyno I've ever had.
One of the worst physicians I have ever encountered. From the initial interview where she told me I was having a boy and how white boys were sick, inferior creatures while looking at my husband, to the 2 hour wait time for an ultrasound, this woman absolutely sucks! Despite her credentials, she has no reason practicing medicine especially where newborn children are involved. Please do not use her or deliver at Richardson Methodist. Her hospital of choice is even worse, and supports her inability to perform her job at a satisfactory level. Go north, where the good doctors and hospitals are.
Dr.Norton is the WORST. Don't come to her if you care about your health. She is inconsiderate of patients time. I waited for 45 min! She rushed me in and out and was not attentive to my needs nor did she apologize about the long wait. There was another lady that had an appointment before me and she said she waited over an hour. PLEASE PLEASE PLEASE do not waist your time coming to see this poor excuse of a doctor.
The absolute worst OBGYN office I have ever been to. They literally don't care about you! In summary, I was miscarrying, called their office multiple times to come in and be seen, and they never returned my phone calls.... How insensitive is that? WARNING: Don't come to this office unless you are ok with being passed over and pushed aside.
Dr Norton is a very good doctor, and she know what she is doing, and explains very well. But, wait time is way too much. Most of the time I ended up waiting more than an hour. I will definately won't recommend, and will not come back after my post partum visits
After a cancellation two days in advance by Dr. Leaf, then a reschedule and cancel of the N.P. I was not at all optimistic as a new patient. What a headache. The staff finally got me in earlier the same day (after I complained) and get me in with Dr. Norton. Had I known how amazing she is, I would have scheduled with her from the start. She consults you CLOTHED (which made me more comfortable and able to really discuss WHY I was there) and when it came down to the exam she was thorough and it wasn't as dreadful as usual. Amazing professional. I HIGHLY recommend - and I am VERY picky.
I am very pleased with Dr. Norton. She is caring and knowledgeable. Answers all questions and takes her time with you. Her office is however very busy and it sometimes takes a bit of a wait, but it is worth the wait to have a good, trustworthy doctor.
Dr. Norton is the best doctor I ever met. She helped me during my pregnancy. She is very friendly. She delivered my baby. She is very professional and very knowledgeable.she listen all my concerns and helped me a lot.
I went to Dr. Norton after reading nice reviews about her. Since it was my first visit, I was expecting that all my queries and concerns will be answered, but was in disappointment after meeting her . She did not take my problems seriously. Instead of helping me with my concerns , she was rather interested in running some tests that was not necessary at that time . She might be a good doctor for some patients but definitely not for me. I will never go back to her again.
Dr. Norton is a good doctor; however, her office is not well-run. I arrived 10 minutes early for my 8:30 appointment, which was the first appointment of the day. Nonetheless, the 9:00 patient was called before me. I waited for well over an hour before I eventually gave up and left without being seen by Dr. Norton. This was not the first time I received poor service at Dr. Norton's office.As much as I like Dr. Norton, I'm seriously considering changing doctors.
Dr Norton has been my doctor for almost a decade-- she delivered both of my sons via section in 2003 and 2006. Cori and her also helped me through post partum depression. She's a fantastic doctor and I would highly recommend her.
I waited over 1 1/2 hours in the exam room and finally left. No one had the courtesy to come in and tell me how late she was running.
Dr Norton performed my endometrial ablation. It was very quick and only caused a tiny cramping that was short. She informed me of her every move and when it was over, I told her that I had had pms cramps that were worse than the entire ablation procedure. I have had absolutely NO menstrual cycles since and only wish I had had the procedure years ago. I have had no side effects. No more cramping, no more pms, and no more cycles. I wish more women knew about this procedure. Dr. Norton's only fault is that she is so good she stays VERY busy.
I have been seeing Dr. Norton for 11 years now!! She is an AMAZING and very CARING doctor. She delivered both my boys, and everything went well. Her staff is very kind and friendly. I would definitely recommend her!!
I HATE the gyn. I'd rather have a root canal. Unfortunately, I have girl parts. So I'm stuck seeing one. Dr Norton is easily the best I've ever seen. She doesn't just diagnose and treat, she explains to me the problem, what causes the problem, and how I can keep the problem from returning. She is thorough and gentle and her office staff if very pleasant. I can't go so far as to say I enjoy our visits, but I don't dread them. Which is a rare and wonderful thing.
She is a very good doctor, takes time to listen and discuss your concerns. Would recommend her.
We used Dr. Norton to deliver our baby; she was great and the Richardson Hospital was suprisingly great too.


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Beach Time Gumballs (1"/850count)
Beach Time Gumballs 1"/850 Count Bulk Case
Beach Time Gumballs are brightly colored gumballs with splashes of more color on top of the solid color. If that sounds confusing, just know that they make us think of lying on the beach every time that we see or eat one of these bright summer gumballs. The Beach Time Gumballs come in the standard one inch size with 850 gumballs per case and will work in commercial gumball machines.
Flavors: Strawberry, blueberry, fruit, lime & banana
Size: 1 inch / 25mm diameter
Quantity: 850 gumballs per case
Weight: 17 pounds
- Good flavorsReview by Shawn Heffner
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