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Post by kc on Feb 10, 2018 9:55:27 GMT -5
Then, frankly, Dr. Kendall will start by getting together with the ADA and AACE to discuss the ramifications of past trial data. Mike Castagna recently stated that MannKind has volumes of Afresa/Afrezza results data accumulated during more than a decade of testing and trial studies that could be organized and published. Perhaps the archives are where the new CMO will begin mapping the road to medical changes for Afrezza, MannKind and its long-patient shareholders.
Good fortune to all. Ditto - Ditto he is a expert and has strong research background. Street Credibility. Urbanski did not have it. Getting a well respected Diabetes guy was something MannKind should have done years ago. This is a better hire than Mike C. Glad it was made by Mike C.
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Post by kc on Feb 10, 2018 9:43:40 GMT -5
Hired as a subject matter expert in Diabetes which helps building Afrezza which is the goal for the next 24 months. No Afrezza sales no MannKind or future pipeline developments. Afrezza is priority number 1. Domestic, North America and Internationally.
Smart hire by Mike and Board. Past CMO was not a Diabetes expert with Street Credebility to the ADA/ENDO crowd.
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Post by kc on Feb 9, 2018 14:58:22 GMT -5
www.denverpost.com/2018/02/07/insulin-disintegrated-diabetes-study/TRENTON, N.J. — Preliminary research suggesting that some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself. The study author, a pharmacist, bought vials of insulin at a number of pharmacies and found that on average the vials had less than half of what was listed on the label and none met a minimum standard.The study tested just 18 vials of insulin — far too few to be definitive — and questions have been raised about the methods used to test the insulin. Insulin makers, patient advocate groups and diabetes experts say if the findings were accurate, diabetes patients would be getting sick. But given potentially serious implications for millions of diabetics, many of these groups are now trying to reassure patients in the wake of the research. All say that patients should continue to taking their insulin as prescribed. The groups are discussing how to quickly mount a major study that would ease fears by involving multiple research labs, different testing methods and many more samples of various insulin types. “We want to make sure the study, when completed, will be well accepted,” said Dr. William Cefalu, the American Diabetes Association’s chief scientific officer. Roughly 6 million Americans inject synthetic insulin every day. Most patients use a syringe to draw insulin from a vial, like the ones tested in the study, then inject it. An increasing number instead use simpler “pens” containing insulin cartridges, pressing them against skin to inject a dose. The study raised such alarm because without enough insulin, patients can, over time, suffer blindness, limb amputations, and life-threatening damage to the kidneys and heart.“The (insulin) concentration and the amount you give, if just a little bit off, can have huge consequences,” said Aaron Kowalski of JDRF, which funds diabetes research. The original study, published Dec. 21 in the Journal of Diabetes Science and Technology, tested insulin solutions in vials bought at multiple pharmacies, supplied by different wholesalers, in Kansas and Missouri. They included insulin made by Novo Nordisk and Eli Lilly and Co.The concentration, or number of insulin units in the liquid solution, was labeled as 100 units per milliliter. But they averaged less than half of that, and none met the 95-unit minimum standard, said lead researcher Alan Carter, a pharmacist and adjunct instructor at the University of Missouri-Kansas City School of Pharmacy. “It blew us all away,” said Carter, who did the research while working at not-for-profit contract research firm MRIGlobal in Kansas City. The U.S. Food and Drug Administration requires that insulin batches be tested before leaving the factory. The insulin then must be kept cool, in a narrow temperature range, as it is shipped to a warehouse and then to pharmacies. The FDA conducts spot checks during the process. Carter thinks the insulin may have gotten too warm somewhere between the factory and the pharmacy, causing some of the molecules to break apart. Carter wondered whether his results might help explain why insulin users sometimes find a dose doesn’t work as well as normal. Doctors usually attribute that to patient error: not injecting enough insulin before a meal, not following dietary guidelines, or skipping exercise. Carter, who had a limited budget for his study, acknowledges that it was too small and that his results may be flawed. He notified Novo Nordisk and Eli Lilly of his results in hopes someone would do a bigger follow-up study. Insulin makers stand by their products, saying they meet strict government quality regulations. Diabetes experts say there’s little chance that insulin being sold nationwide is so degraded. “If that were true, then you would have the emergency rooms full with uncontrolled diabetic patients,” said Bernd Meibohm, a pharmaceutical sciences professor and research director at the University of Tennessee College of Pharmacy. Experts say there are multiple methods of testing insulin concentrations and that Carter’s group used a sophisticated one, known as LCMS for short. Dr. Richard Ostlund, an endocrinologist and professor who heads a large testing lab at Washington University School of Medicine in St. Louis said that method is typically used for testing insulin levels in blood, not vials. He said that test likely couldn’t detect much of the insulin in the vials because it clusters together there, while in the blood it separates into individual molecules. He and other experts say diabetics should not change their treatment at all. “Patients should not do anything different in response to this,” Ostlund said. He noted his lab has tested insulin for various research projects and always found vials contained close to what’s listed on the label. Interesting study. You have to think that might be a good reason to sell the benefits / stability of Afrezza dosing
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Post by kc on Feb 9, 2018 14:54:46 GMT -5
Horrible.........
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Post by kc on Feb 8, 2018 23:32:40 GMT -5
One more example of his presentation style on the subject of Type 2 Beta Cells.
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Post by kc on Feb 8, 2018 23:02:28 GMT -5
If you do a search on YouTube you’ll find more than 15 different videos that David Kendall has been involved it is either the presenter throughout his career. This is an example of one he did during the 71st ADA convention.
You can see what kind of Presence he has he has presenting. He seems to be the consummate Diabetes expert. MannKind is very fortunate to have landed a person with this guy’s credentials. a world known Diabetes expert.
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Post by kc on Feb 8, 2018 22:46:01 GMT -5
LinkedIn profile has not been updated. but interesting has he must have just left Lilly
David Kendall •
Vice President - Medical Affairs - Lilly Diabetes Eli Lilly and Company • University of Minnesota Medical School
Experience Eli Lilly and Company
Vice President - Global Medical Affairs - Lilly Diabetes
Company Name Eli Lilly and Company
Dates Employed Jun 2014 – Present
Employment Duration •3 yrs 9 mos
Location Indianapolis, Indiana Eli Lilly and Company
Distinguished Medical Fellow - Global Medical Affairs - Lilly Diabetes
Company Name Eli Lilly and Company
Dates Employed Jul 2011 – Jun 2014
Employment Duration •3 yrs
Location indianapolis, indiana area
Yep! Mike delivered big-time for MannKind. 👍 He hired the guy who will get us to the promise land.
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Post by kc on Feb 8, 2018 16:05:28 GMT -5
Watching trading the last 30 mins today and couldn't figure out why the clock stopped for trading of MannKind shares. Look at this time snapshot. 15:25:13 until 15:31:06 just really sitting with minimal trading. Was it a lack of shares available. So I couldn't figure it out why so I didn't follow my MannKind 10 step program and get myself in deeper again. Hopefully I won't be sorry. It took 3 bites to fill my market order.
very strange only 4 trades over 10,000 shares today with one of them being for 250,000 shares.
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Post by kc on Feb 7, 2018 16:47:21 GMT -5
Great hire. I just hope he doesn't pull a McDaniels or get the DeSisto whammy (which now with Mike I'm glad that happened). Interesting comment as one would think there was a not to compete/ non-disclosure agreement that he signed with Lilly. Sound like a very friendly hire by MannKind.
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Post by kc on Feb 7, 2018 10:41:24 GMT -5
www.abstractsonline.com/pp8/#!/4482/presentation/7197 Authors Swashti Agarwal, MD, Meenal Gupta, MD, Sheila Gunn, MD. Baylor College of Medicine, Houston, TX, USA. Disclosures S. Agarwal: None. M. Gupta: None. S. Gunn: None. Abstract Subcutaneous insulin resistance syndrome (SIRS), a rare entity, is characterized by increased resistance to subcutaneous (subQ) insulin, normal sensitivity to intravenous (IV) or intramuscular (IM) insulin with no increase in circulating insulin antibodies. Not much is known about its patho-physiology, but it has been suggested to occur due to rapid subcutaneous degradation of insulin. Multiple treatment modalities have been used in the past including IV or IM insulin, intra-peritoneal implants, human recombinant hyaluronidase and protease inhibitors. We illustrate a similar case here and describe the challenges in management with different modalities, eventually using inhaled insulin, which was recently FDA approved for use in adults with Type 1 diabetes. Our patient was a 17 years old non-obese (BMI: 24.6kg/m2) Caucasian female diagnosed with Type 1 Diabetes Mellitus four years ago and well controlled (HbA1c ~ 7.5%) on Aspart insulin via pump at home. She initially presented with Diabetes Ketoacidosis (DKA) at an outside hospital, which resolved within 24 hours of starting IV insulin drip. They encountered difficulties transitioning her but finally discharged her on regular insulin via pump. She presented with ketosis two days later, failed to respond to multiple correction boluses of subQ insulin leading to DKA. This resolved with IV insulin and fluids. Various subQ insulin formulations were tried and metformin added, however she developed DKA again. She was then transferred to our center for further management. DKA was initially managed with IV insulin. To transition, we tried subQ Novolin-R insulin since patient's mother reported that it was the only insulin formulation that she had responded to. Blood sugars trended up and ketosis developed within 10 hours of starting this regimen despite increasing doses to 5.6 units/kg/day. Insulin antibodies were 4.5U/mL (ref: less than 0.4U/mL) - not significantly elevated. Given suspicion of SIRS, we started IIM (intensive insulin management) regimen using IM insulin (Lantus and Lispro). This improved glycemic control however, necessitated 5 painful IM injections per day leading to patient dissatisfaction. Hyaluronidase injection at the pump site was used to facilitate increased absorption of insulin however patient failed to respond and developed ketosis. While awaiting approval and availability of inhaled insulin , hyperglycemia was managed with IM/IV insulin.With inhaled insulin (Afrezza) and IM lantus use, blood glucose remained in 90-130mg/dL range and she was discharged home on this regimen after total of 3.5 weeks of hospitalization . SIRS is a difficult condition leading to prolonged hospital stay, patient frustration and carries a serious risk of recurrent DKA. We report this case to create awareness about this entity and the use of inhaled insulin, and to provide insight into the challenges faced while managing this condition. Amazing abstract.... Hopefully somebody will pay attention to the presentation.
Think about the cost of 3.5 week hospital stay for patient and the insurance carrier or for the Medicare or Medicaid system.
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Post by kc on Feb 6, 2018 21:49:21 GMT -5
They are a mess and Trulicity may actually be the worst. The lawsuit is not about the fact these drugs cause serious issues. The companies admit to that. The suit is about the fact that since the FDA did not require them to disclose on the label how bad they are its the FDA's fault and they are not responsible. IMO they should all be pulled and tell the PWD to eat higher fat meals or take afrezza. But then it gets worse with Jardiance. How many commercials are telling us its heart healthy? Too bad they are not telling us people are losing toes, feet, fingers and limbs thanks to this heart healthy mess. If they want to get heart healthy lets approach non-diabetic TIR and save a few toes. Maybe that's why Kendall is here. Maybe he too is tired of all these companies pushing these very dangerous concoctions. I sure hope he knows how to sell. Maybe you hit the point Afrezza is not a CONCOCTION... it is INSULIN. I find it strange that he left Lilly so fast that he didn’t correct his linkedin page. I know that Lilly had some layoff’s last year but not sure in what areas the layoff’s occurred. But most people who have left a company update their LinkedIn site in a timely fashion. he was there back in October 2017 Spend some time on the Lilly Diabetes web site. They really are a fine company with a history of leadership in the Diabetes space. It’s a very good history. www.lillydiabetes.com/heritage.aspxI would not be afraid of a Buy In by Lilly for the international rights. Say they purchased 20% of the company with newly minted shares for $20.00 per share. MannKind retains domestic United States rights and Lilly gets the Worldwide distribution rights. MannKind keeps the manufacturing of Afrezza. MannKind shares would rocket up immediately to $20.00 and burn all the shorts. Last year according to the Lilly Investor relations site they did an investment conference at a company event Leerink Partners Global Health Conference. That event was February 16th, 2017. The presenter was Enrique Conterno, Sr VP and President — Lilly Diabetes. Conterno is Now Lilly US President. The 28:57 minute presentation is still on their web page. Moving forward one year they are presenting again at Leerink Partners on February 15, 2018. What are they presenting this year? Nobody knows. I have circled my Calendar for February 12th as it seems like a Monday Pre-Market would be a good time for any important announcement from MannKind if there is something to report. I am not SPECULATING there that would be any news. It’s just a good day for news if there is any to report.
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Post by kc on Feb 6, 2018 18:39:25 GMT -5
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Post by kc on Feb 6, 2018 18:05:12 GMT -5
I think that either Mike did a great job of hiring David Kendall or there is more excitement in the near term future for all of us.
Kendall is a player and he was very important to Lilly. If you go to the Lilly web site and do a search for his name he appears on many of the press releases regarding Lilly diabetes products.
investor.lilly.com/search.cfm?method=and&keyword=David+Kendall
Below are a few excerpts of what I found:
DAVID KENDALL
2017 investor.lilly.com/releasedetail.cfm?ReleaseID=1040017 "Cardiovascular disease remains the leading cause of death in people with type 2 diabetes and contributes significantly to the burden of diabetes care," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "The results presented at EASD add further evidence of the benefit Jardiance can provide to adults with type 2 diabetes with different background blood sugar control."
2016 investor.lilly.com/releasedetail.cfm?releaseid=975348
"MOSA1c provides a broad view of clinical, psychosocial and health system factors available and will serve to create a greater understanding of needs within each system," said David Kendall, vice president, Global Medical Affairs, Lilly Diabetes. "These data can help us better understand why so many patients using insulin are not achieving glycemic goals. We know that this is a complex multi-factorial issue and it is critical to take into account the specific cultural, social and individual barriers people with diabetes face when adjustment of insulin therapy is considered most useful."
2016 investor.lilly.com/releasedetail.cfm?releaseid=1004325
"Lilly and Boehringer Ingelheim are proud to bring another proven effective diabetes treatment choice to people who may need a long-acting insulin to help control their blood sugar," said David Kendall, M.D., vice president, Global Medical Affairs, Lilly Diabetes. "We know that starting insulin can be a challenging experience for some people with type 2 diabetes. As part of our continuing commitment to the diabetes community, we are expanding our educational resources."
2016 investor.lilly.com/releasedetail.cfm?ReleaseID=953190 "We at Lilly Diabetes take great pride in our support of diabetes camps. For more than a decade, many individuals have reported positive experiences and shared how important the camp experience is for children with diabetes as they learn to care for themselves," said David Kendall, MD, vice president of medical affairs, Lilly Diabetes. "These exciting survey results help confirm that campers are having a positive experience. We couldn't be happier that our donations to the Association's Campership program are having such an impact."
2015 investor.lilly.com/releasedetail.cfm?releaseid=916577 "We are honored to continue partnering with IDF on Life for a Child," said David Kendall, M.D., vice president for medical affairs, Lilly Diabetes. "Through this new commitment of insulin, we will build on the substantial impact that Life for a Child has had in communities with very significant needs across the globe. Our commitment to these children will help them manage their diabetes and have much brighter futures."
2015 investor.lilly.com/releasedetail.cfm?releaseid=914967 INDIANAPOLIS, May 27, 2015 /PRNewswire/ -- New clinical data demonstrating the range of treatment options represented in Lilly's (NYSE: LLY) diabetes portfolio will be presented in 79 abstracts on June 5-9, at the 75th American Diabetes Association (ADA)® Scientific Sessions in Boston. These presentations reflect Lilly's efforts to enhance scientific knowledge and improve current approaches to diabetes management. Thirty-five of the abstracts will be presented as part of the Boehringer Ingelheim-Lilly Diabetes alliance. "The Scientific Sessions are an important opportunity for researchers and healthcare and industry professionals to come together and share learnings and advances in diabetes care," said David Kendall, M.D., vice president of Medical Affairs, Lilly Diabetes. "We look forward to communicating significant new data that showcase the full range of our diabetes portfolio."
The relationship with Lilly and Kendall goes back to 2007 when Kendall worked for Amylin Pharmaceutical and their joint venture work on Byetta.
2007 investor.lilly.com/releasedetail.cfm?releaseid=250792 "The sustained improvements in blood glucose control and the secondary benefits of progressive weight loss seen with BYETTA are well documented," said David Kendall, Executive Director, Medical Affairs, Amylin Pharmaceuticals, Inc. "These studies document that BYETTA may have additional and important effects on cardiovascular disease risk factors providing interesting areas for further study, including additional metabolic advantages of weight loss in people with diabetes."
I am probably letting my mind and fantasy of the future getting the best of me but perhaps there is a bridge to the future of MannKind in the comments made by Lilly CEO at JPM 2018.
www.lilly.com/6-thoughts-from-dave-ricks-jpm-talk
Key priorities for Lilly moving forward: 1.Launch with excellence, introducing our newest set of medicines around the world. 2.Reload our pipeline, with promising opportunities in our labs and outside to take the place of an exciting graduating class of new medicines.
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Post by kc on Feb 6, 2018 16:48:00 GMT -5
He has been Living in Indy since 2011
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Post by kc on Feb 6, 2018 15:18:10 GMT -5
LinkedIn profile has not been updated. but interesting has he must have just left Lilly
David Kendall •
Vice President - Medical Affairs - Lilly Diabetes Eli Lilly and Company • University of Minnesota Medical School
Experience Eli Lilly and Company
Vice President - Global Medical Affairs - Lilly Diabetes
Company Name Eli Lilly and Company
Dates Employed Jun 2014 – Present
Employment Duration •3 yrs 9 mos
Location Indianapolis, Indiana Eli Lilly and Company
Distinguished Medical Fellow - Global Medical Affairs - Lilly Diabetes
Company Name Eli Lilly and Company
Dates Employed Jul 2011 – Jun 2014
Employment Duration •3 yrs
Location indianapolis, indiana area
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