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Post by mannmade on May 25, 2018 13:22:14 GMT -5
With interest rates starting to climb perhaps we will see more of this ?
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Post by mannmade on May 23, 2018 20:50:46 GMT -5
www.salon.com/2018/05/22/some-startups-say-they-can-reverse-diabetes-not-all-scientists-agree/Some startups say they can reverse diabetes. Not all scientists agree Scientists disagree over whether diabetes can truly be reversed. The answer is way more complicated NICOLE KARLIS MAY 22, 2018 11:00PM (UTC) Diabetes is one of the most common diseases in the United States: nearly 1.5 million cases of diabetes are diagnosed each year in America. Moreover, according to the American Diabetes Association, diabetes ranked seventh among leading causes of death in the U.S. in 2015. Yet in the past few years, there is growing debate over whether or not the chronic disease — specifically, type 2 — can be “reversed.” You might have seen the headlines: both the Guardian and The New York Times published stories that claimed type 2 could be "reversed"; meanwhile, the Joslin Diabetes Center at Harvard Medical School has an article stating definitively the opposite. The truth is more complicated and speaks to the complexities of research and the tendency of the news media to sensationalize small (yet still sound) scientific studies. First, some background for those who are fortunate enough to not be affected by diabetes: Type 1 diabetes occurs when the pancreas produces little to no insulin. Type 2 diabetes is when one’s body either resists or does not produce enough insulin. (Insulin is a hormone that manages the glucose level in the body.) Type 1 cannot be reversed; there is not much debate around that, although there is a startup purportedly trying to cure it. Yet there are conflicting theories over whether type 2 can be reversed — though it is pretty well-established that it can be managed through diet and exercise. Considering one in three adults are at risk for the disease, according to the Centers for Disease Control and Prevention (CDC), it should come as no surprise that Silicon Valley sees a chance to capitalize on diabetes treatment. Recently, multiple ventures have popped up in the biotech world, some of which make provocative claims. Case in point: Virta Health, a San Francisco-based startup that raised $45 million in their last round of financing and aims to reverse diabetes through a mix of a nutritional intervention, nutritional ketosis and machine-learning. (Nutritional ketosis is the process in which fats and ketone fuel your body, instead of carbohydrates; it is similar to the ketogenic diet known as “keto.”) According to a study the tech company funded, which was published in the SpringerLink journal and peer-reviewed, a “novel metabolic and continuous remote care model can support adults with [Type 2 diabetes] to safely improve HbA1c, weight, and other biomarkers while reducing diabetes medication use.” In other words, there was some success in using this method to “reverse diabetes” — which, by Virta's standards, means lowering HbA1c level, the marker to measure glucose concentration, to below 6.5. “I think what a lot of conventional diabetes care focuses on is the management of the disease, to continue to take your medications and hope to slow the consequences,” James McCarter, MD PhD, Head of Research at Virta Health, told Salon. “We don’t believe that is correct, we believe you can achieve reversal.” But there is a caveat. “We don’t mean that it is a cure and you can do whatever you want and be fine,” he added. “We recommend that people stay in nutritional ketosis, maintain dietary changes long-term and make permanent lifestyle changes.” Virta Health is not the only startup trying to reverse the disease. Semma Therapeutics, a startup that aims to cure type 1 diabetes, has raised over $100 million for stem cell therapy research. Michael German, a professor at the Diabetes Center at the University of California, San Francisco, said achieving true "reversal" of type 2 diabetes is unlikely. “You can improve your blood sugar, with diet and exercise, but the underlying propensity for type 2 diabetes does not go away,” he said. “As soon as you stop [lifestyle changes], it will come right back.” Dr. German also warned that a lot of the success in managing diabetes depends on the patient's genetic propensity. He explained that it is easier for someone with an early onset of diabetes to manage the disease without medication than it is for someone who has had it for years. In both cases, he says a change in diet and adding exercise to one’s lifestyle can always help someone who has the disease. This is not meant to be a he-said, she-said account. Indeed, German and McCarter are saying basically the same thing about how patients can manage their diabetes, even if they disagree about what "reversal" means and if it is possible. In an interview with Healio in 2014, researcher Yann Klimentidis, PhD, assistant professor of epidemiology at the University of Arizona’s Zuckerman College of Public Health, wrote: “The bottom line is that, although this area of research is still in its infancy, prevention and treatment measures for type 2 diabetes could eventually be more precisely tailored to an individual’s genetic profile.” And perhaps that is what researchers and doctors should be aiming for: the "third way" of individual treatment plans, rather than hype over a diabetes "cure" or "reversal" that doesn't really mean that the disease is gone forever.
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Post by mannmade on May 21, 2018 20:19:22 GMT -5
I think Al Mann had it right for the T1s. A simple patch pump for the basal plus afrezza for the bolus. Maybe Dr. Kendall can tell these people to save their money as old school pumps with old school RAA's with a new paint job have been obsoleted. Totally agree. Although I am not diabetic, I would much rather have a cgm and one shot a day of Tresiba than be hooked up to a pump all the time even if it is an artificial pancreas. Much more complicated to maintain, bulkier and can still malfunction... just my opinion... |
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Post by mannmade on May 21, 2018 20:09:20 GMT -5
Sayhey, With all due respect and I mean respect... I do not think Dr. K getting here any earlier would have made that much of a difference. I think his appearing now is very timley and also in the nick of time....
My reasoning is based on a post I just wrote under I think I can... Dr. Kendall is the perfect person for the moment with the advent of the FDA ruling on CGM's being accepted for insulin dosing and the ADA now changing the way they review the SOC. Both of these events only occured within the last six months or so...
Without them, the conversation is much harder to have as to why Afrezza is better even though we know it is. I am speaking about overcoming the entrencehed interests of big pharma and the insular insurance/medical community.
Now there is a reason for Afrezza to exist that most doctors, and yes, insurance companies should come to understand... It's called TIR and Afrezza is the best product on the market and will be so for the next 7 to 10 years to manage TIR. "Real time for the first time" in the care of diabetes management and with it less long term effects from living with diabetes.
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Post by mannmade on May 21, 2018 19:53:07 GMT -5
While in the past we might have said I think we can, I think we can...,(to paraphase the title of this thread) today I am confident enough to say I know we can, I know we can... It occurred to me while attending the ASM, that It is really only within the last six months imho, with the advent of certain specific events having taken place, that I finally feel after all these years, comfortable saying with a high degree of confidence as never before, that we will see Afrezza successfully be adoptied as the standard of care. With the benefit of hindsight, I would have to say the battle may have been too tough given the entrenced interests that seem to pervade the diabetes care market. However, now "the train is definately leaving the station" and will not be looking back for much longer imho... 1. FDA rules that CGM's can now be used for dosing guidance of insulin This makes TIR a more prominent story as real time dosing and management are now at the forefront of the diabetes care discussion, with the records to prove it as Peppy so likes to point out.  And this means that Mnkd has new and valuable allies in this discussion who can do lots of the heavy lifting to promote this change in discussion from Hba1c to TIR in Dexcom, Abbott, etc... 2. ADA announces that it will now consider review of the Standard of Care as an on-going year round dialouge instead of once a year updates Instead of a once a year update the ADA will now look at the SOC year round enabling more robust conversations and a constant dialouge that should support the findings that come out of the records from #1 above. 3. Hiring of Dr. K by mnkd. And who better to interpret items 1 and 2 abive and introduce Afrezza into the conversation as the best option to facilate TIR, both because of it's best in class effectivieness (PK/PD profile) and ease of use. Dr. K without items 1 & 2 does not work so well and items 1 & 2 without Dr. K do not work so well either imho, but together they provide both the fuel and the conductor that can get this done... While I agree with others on this board that the stat study results to be revealed at the coming ADA meeting are not likely to have an immediate effect on Afrezza sales, the results when announced will begin to lay an important part of the train track that enables Afrezza to move forward on it's journey and take us all along for the ride while helping pwd lead a longer and heaalthier life... GLTAPWD and GLTAL's... |
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Post by mannmade on May 21, 2018 19:29:15 GMT -5
markets.businessinsider.com/news/stocks/beta-bionics-receives-ide-approval-from-the-fda-to-begin-a-home-use-clinical-trial-testing-the-new-ilet-bionic-pancreas-system-1025064716Beta Bionics Receives IDE Approval from the FDA to Begin a Home-Use Clinical Trial Testing the New iLet™ Bionic Pancreas System PRESS RELEASE GlobeNewswire May. 21, 2018, 08:00 AM First trial to test Fiasp® – Novo Nordisk’s latest formulation of fast-acting insulin aspart – using autonomous insulin delivery The bionic pancreas will also be tested with the conventionalformulations of insulin aspart and insulin lispro in both adults and children with type 1 diabetes who use either an insulin pump or multiple daily injection therapy for their usual care Trial to use Dexcom’s Continuous Glucose Monitoring System BOSTON, May 21, 2018 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. – a medical technology company leveraging machine learning artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D). Adults 18 years and older with T1D will be recruited through Massachusetts General Hospital and Stanford University, and children 6-17 years old with T1D will be recruited through Nemours Children’s Health System, the Barbara Davis Center for Diabetes at the University of Colorado, and Stanford University. The US-based multicenter, multi-arm, cross-over, clinical trial is the first of its kind, testing Novo Nordisk’s recently approved, fast-acting insulin called Fiasp® with the iLet bionic pancreas system in adults with T1D, and insulin lispro and conventional insulin aspart using the iLet in adults and children with T1D. This trial is also the first to use the new Beta Bionics-manufactured iLet device, which is capable of dosing only insulin, only glucagon, or both hormones as needed. The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. With unprecedented simplicity of use, the iLet requires only body weight for initialization. Once initialized, the iLet engages its machine-learning, artificial intelligence to autonomously control the individual’s blood-glucose levels, and to continuously adapt to the individual’s ever-changing insulin needs. The iLet to be used in this trial integrates glucose data from the Dexcom G5 Continuous Glucose Monitoring (CGM) System. “The design of this ambitious insulin-only bionic pancreas study builds on the foundation of previous studies we have conducted with our clinical collaborators testing our bionic pancreas algorithms with previous investigational platforms,” said Ed Damiano, Founder and CEO of Beta Bionics, and Principal Investigator of the trial. Dr. Damiano is also a Professor of Biomedical Engineering at Boston University. “This trial is exciting not only because it represents the first time we will be able to test our bionic pancreas algorithms with our own proprietary iLet platform, and not only because it will include both children and adults with T1D, and not only because it will draw upon those who use MDI therapy in equal number to those who use insulin pumps for their usual care, but also because we will be breaking new ground by being the first group to test autonomous insulin delivery using Fiasp®.” “The iLet Bionic Pancreas System trial is a concrete example of patient-centered innovation, and it is ultimately through innovation and research that we’ll defeat diabetes,” said Stephen Gough, Global Chief Medical Officer of Novo Nordisk. “We are proud that Fiasp®, our ultra-fast acting insulin, has been chosen for this trial, among other rapid-acting insulins and look forward to see the results. The intent is to show meaningful benefits for people living with diabetes in need of this technology.” Novo Nordisk, an investor in Beta Bionics, has partnered with Beta Bionics to carry out several co-development activities. Eli Lilly and Zealand Pharma are also investors and development partners. Dexcom is a development partner with Beta Bionics as well and recently received FDA approval of its G6 Dexcom under the new interoperable CGM designation (iCGM). “We have worked with Beta Bionics and Ed Damiano’s team for many years to provide our highly accurate and reliable CGM technologies to drive the bionic pancreas,” said Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom. “We support the efforts of Beta Bionics to bring their iLet bionic pancreas system to market and look forward to seeing our G6 system incorporated into their future iLet platform and validated in future clinical trials.” Beta Bionics plans to enter pivotal trials with its final iLet design in 2019 and expects to launch its first product in 2020. About the IDE and PMA process Investigational use of the iLet was approved by the FDA under an investigational device exemption (IDE). An IDE allows testing of an investigational device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application to the FDA. An IDE application is approved only after extensive review by the FDA of the device and clinical trial design. About the iLet The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The machine-learning mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, reductions in hypoglycemia, and reductions in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80). The iLet is initialized by entering body weight only and does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas. The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations. About Fiasp® (insulin aspart injection) 100 U/mL Fiasp® is a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Fiasp® is the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp® should be administered at the beginning of a meal or within 20 minutes after starting a meal due to its appearance in the blood in approximately 2.5 minutes.* *Reference: Fiasp® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017. About Beta Bionics Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate machine-learning artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, which will be followed by its dual-hormone system that will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.
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Post by mannmade on May 20, 2018 10:51:29 GMT -5
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Post by mannmade on May 17, 2018 10:09:43 GMT -5
Also both Mike and Dr. Kendall stated they did not see or know of another product that can do as well what AFREZZA can do coming along in next 10 year’s.
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Post by mannmade on May 17, 2018 9:59:06 GMT -5
One quick clarification Mike C stated almost all patents good until 2031/32 and there are over 800 of them. He has never seen a drug so well protected. It is very expensive to do.
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Post by mannmade on May 14, 2018 15:25:43 GMT -5
Depends on whether or not you think AFREZZA is the best prandial insulin
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Post by mannmade on May 14, 2018 13:02:49 GMT -5
Thanks Peppy. Exactly why I chose them as my example for the above thought on partnership...
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Post by mannmade on May 14, 2018 12:23:26 GMT -5
On it Baba! |
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Post by mannmade on May 14, 2018 12:10:36 GMT -5
I am not sure if they will sell AFREZZA or not as anything is possible and very hard to speculate at this point with what we actually know.
Having said that we know mnkd needs money and cannot continue to limp along like this w/o funds to more actively promote AFREZZA and buy time to do so such that scripts incease significantly whether domestically and/or internationally eg: next 2 year’s or so.
Imho I think the best way forward would be a deal like Sanofi did with Regeneron. (I am not suggesting Sanofi as a partner, only using as an example). Even w such a low stock price if say Lilly bought $50m worth of shares at 1.90 (or whatever price seems reasonable to mnkd) they would receive let’s say between 20m and 30m shares (just estimate as based on price range of pps at time of transaction using today’s pps as target)
So this would give Lilly about about 20% ownership of mnkd given 30 m shares takes outstanding share count to 150m.
Pps share should rise significantly with such a deal. Then mnkd can go raise another 100m or so with what could be one last dilution.
Mnkd then has a great partner who knows this space and could help market and gain access to Ins by bundling AFREZZA w Lilly products.
Mnkd has a war chest of $150m to ramp up promotion of AFREZZA.
And best of all mnkd stock stays with shareholders who get to realize the value of AFREZZA and TS (whatever that may be)
Also Lily’s investment is almost a neutral transaction financially if the mnkd pps rises enough (as it should) that they recover investment and profit moving forward.
$50 m is nothing for Lilly or some other pharma in the playbook.
Also this way the overseas deals do not hamper a deal getting done.
All just my opinion. But that is what I would try and structure if that was Mike C.
GLTAL’s!!!
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Post by mannmade on May 12, 2018 17:24:17 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers. The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service. Did you say Lilly? Hmmm.... |
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Post by mannmade on May 4, 2018 11:45:13 GMT -5
Either way this is great news!!! Thx MN!
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And this means that Mnkd has new and valuable allies in this discussion who can do lots of the heavy lifting to promote this change in discussion from Hba1c to TIR in Dexcom, Abbott, etc...