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Post by ktim on Apr 8, 2019 14:13:21 GMT -5
@scotta who said "This fall things get interesting." You mean the past 5 or 6 years haven't been interesting? I don't think my nerves can take things being too much more interesting for MNKD.
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Post by agedhippie on Apr 8, 2019 17:18:52 GMT -5
There will come a day when fee for outcomes is the norm and fee for service is no more. When time in range becomes the measuring stick for fee for outcomes, which Rx products for people with diabetes will garner the greatest reimbursement? This fall, DexCom will have their production lines up and running for their new, very small and inexpensive CGM. Diameter is between a nickel and quarter and around twice as thick as the latter. It will send continuous glucose readings to a smartphone and from there, the possibilities are endless. What % of the patient population has a compliant A1c and what % of patients on a CGM have good time in range? This fall things get interesting. Will some of the big players making oral meds for diabetes want Afrezza so they can go toe to toe with Lilly, Novo and Sanofi? Unfortunately according to Dexcom's CEO it's likely to be late 2020/early 2021 before the Dexcom slimline disposable sensor is available. I wish it would be sooner.
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Post by Thundersnow on Apr 8, 2019 22:33:57 GMT -5
Did anyone catch Mike's comment about creating a SUPER CHARGED Manufacturing Facility for High Potency Drugs?? I was making the association with TreT but UTHR is supposed to be opening their own manufacturing facility.
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Post by ktim on Apr 9, 2019 0:29:53 GMT -5
Did anyone catch Mike's comment about creating a SUPER CHARGED Manufacturing Facility for High Potency Drugs?? I was making the association with TreT but UTHR is supposed to be opening their own manufacturing facility. No I missed that. Did our CEO actually talk about super charged manufacturing for high potency drugs? That's funny. Though not in a good way.
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Post by prcgorman2 on Apr 9, 2019 6:14:31 GMT -5
Why is it funny?
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Post by boca1girl on Apr 9, 2019 6:57:22 GMT -5
I did not hear that in the presentation. The joke is about “high potency”. Think Viagra.
I just listened to the webcast again this morning and I did not hear Mike mention anything about “high potency/capacity molecules” even though Mango posted about it yesterday in new patents.
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Post by Clement on Apr 9, 2019 7:19:43 GMT -5
Re: high potency and high capacity? See Mango's post in another thread: "HIGH CAPACITY DIKETOPIPERAZINE MICROPARTICLES AND METHODS Application Date: 04.10.2018 Publication Date: 14.03.2019 Applicants: MannKind Corporation Inventors: Marshall Grant Paul Menkin Grayson W. Stowell Abstract: (EN) Disclosed herein are diketopiperazine microparticles having high capacity for adsorbing a drug or active agent. In particular, the diketopiperazine microparticle are formed using fumaryl diketopiperazine and can comprise a drug in large doses for the treatment of disease or disorders by pulmonary delivery via oral inhalation." Read more: mnkd.proboards.com/thread/8056/mnkd-patents#ixzz5kbGCKbl9
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Post by mnholdem on Apr 9, 2019 14:21:26 GMT -5
Regarding Cohort 3 of the ped trial, didn’t Mike say that they needed to sign up four more recruits?
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Post by Thundersnow on Apr 9, 2019 17:03:40 GMT -5
Yes but he wasn't clear if that's for Cohort 2 or 3. He might have been vague intentionally but didn't mention "Cohort 3" but did mention Phase 3 later this year.
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Post by Clement on Apr 9, 2019 19:19:57 GMT -5
Slide 26
1H Anticipated Events: One of the listings is Completion of formulation work for unnamed compound for UTHR.
I would love to see this happen and advance to the next stage. This quarter!
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Post by boca1girl on Apr 12, 2019 7:13:49 GMT -5
Did anyone catch Mike's comments that MNKD has tested kids down to 8 years old? Apparently there will not be a COHORT 3 and will go straight into a Phase 3 Trial which also means they can file in the EU and other countries. HUGE Development IMO. I just asked a Pediatric Endo and he said the prime age for kids becoming Type 1 is 3-6 years old and teenage years so I'm wondering why MNKD will not do a cohort 3 unless the FDA is not requiring it? Which could be good news. I listened but heard something a little different. I heard they were just about done with Cohort 2 but did not hear that they were cancelling Cohort 3. I’ll have to listen again. Update: at 20:00 mark he talked about pediatrics. He did not say anything about Cohort 3 but did say we could go into Phase 3 after finishing Cohort 2 and then mentioned that we can file for European approval. If you listen to this webcast posted by kimi this morning, Mike talks about dosing 4-7 year olds (Cohort 3) right now for the pediatric trial. diabeticlifestyle.libsyn.com/episode-32-all-about-afrezza
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Post by mango on Apr 12, 2019 17:31:49 GMT -5
I listened but heard something a little different. I heard they were just about done with Cohort 2 but did not hear that they were cancelling Cohort 3. I’ll have to listen again. Update: at 20:00 mark he talked about pediatrics. He did not say anything about Cohort 3 but did say we could go into Phase 3 after finishing Cohort 2 and then mentioned that we can file for European approval. If you listen to this webcast posted by kimi this morning, Mike talks about dosing 4-7 year olds (Cohort 3) right now for the pediatric trial. diabeticlifestyle.libsyn.com/episode-32-all-about-afrezzaNice interview. I think the woman interviewing them asked some good questions, several of them were actually from people that wrote a question in to be asked. Lots of great information covered in this one.
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Post by sportsrancho on Apr 12, 2019 17:44:09 GMT -5
There sure was! Really enjoyed it
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Post by Chris-C on Apr 13, 2019 17:28:51 GMT -5
There sure was! Really enjoyed it I enjoyed it as well. I couldn't help but conclude, after listening to this, that Michael was correct when he observed at the beginning that sometimes change happens more slowly than might be ideal, for a number of reasons.(A reality long investors on this board feel only too acutely!) I recall that when Afrezza was first approved by the FDA, there was considerable talk on this board about the imposition of a requirement for getting a lung function test to establish a baseline as a hindrance to prescribing. It turns out that the much bigger problem is the prior authorization hassles and the tendency for primary care providers to continue doing what they've been doing, because it's easier all around. I thought he deftly handled the interviewer's question about insulin cost, and did a great job of describing the categories of insured users and the advantages of DTC as a way of reducing costs. Michael did a great job of delivering the messages that (1) it's difficult to compare Afrezza to injected insulin for many reasons (in terms of dosing, efficacy and the kinetic profile of the compound, which works like a pancreas doing its work quickly and getting out of the system quickly) and that the total cost of care (costs associated with syringes, injection site infections, hypoglycemic events, and other complications) is the value outcome providers and insurers should be seeking when considering costs vs benefits. The information on why Afrezza works so quickly was well illustrated by Michael using the tennis court analogy, i.e., the lungs have a huge area for absorbing the powdered insulin which helps speed absorption and release into the bloodstream. He also pointed out that the precise metering of the dosing and predictability of its effect is quickly learned by individuals from their own experience. Hopefully, time in range as an outcome will eventually become a more widely used standard for efficacy. Afrezza blows away the competition here. Having a very credible physician user on the call was quite effective, I thought. I could easily imagine listeners quickly grasping the advantages of using Afrezza and being alerted to the minor challenges associated with switching from injectables. This was the first time I had heard that the cartridge size choices (4,8,12 unit) were dictated by the FDA and not a company decision. GLTAL Chris C (Waiting, waiting, waiting, patiently). I remain confident that the leadership team has a credible plan and the competence to execute it.
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Post by boca1girl on Apr 13, 2019 17:53:52 GMT -5
There sure was! Really enjoyed it I enjoyed it as well. I couldn't help but conclude, after listening to this, that Michael was correct when he observed at the beginning that sometimes change happens more slowly than might be ideal, for a number of reasons.(A reality long investors on this board feel only too acutely!) I recall that when Afrezza was first approved by the FDA, there was considerable talk on this board about the imposition of a requirement for getting a lung function test to establish a baseline as a hindrance to prescribing. It turns out that the much bigger problem is the prior authorization hassles and the tendency for primary care providers to continue doing what they've been doing, because it's easier all around. I thought he deftly handled the interviewer's question about insulin cost, and did a great job of describing the categories of insured users and the advantages of DTC as a way of reducing costs. Michael did a great job of delivering the messages that (1) it's difficult to compare Afrezza to injected insulin for many reasons (in terms of dosing, efficacy and the kinetic profile of the compound, which works like a pancreas doing its work quickly and getting out of the system quickly) and that the total cost of care (costs associated with syringes, injection site infections, hypoglycemic events, and other complications) is the value outcome providers and insurers should be seeking when considering costs vs benefits. The information on why Afrezza works so quickly was well illustrated by Michael using the tennis court analogy, i.e., the lungs have a huge area for absorbing the powdered insulin which helps speed absorption and release into the bloodstream. He also pointed out that the precise metering of the dosing and predictability of its effect is quickly learned by individuals from their own experience. Hopefully, time in range as an outcome will eventually become a more widely used standard for efficacy. Afrezza blows away the competition here. Having a very credible physician user on the call was quite effective, I thought. I could easily imagine listeners quickly grasping the advantages of using Afrezza and being alerted to the minor challenges associated with switching from injectables. This was the first time I had heard that the cartridge size choices (4,8,12 unit) were dictated by the FDA and not a company decision. GLTAL Chris C (Waiting, waiting, waiting, patiently). I remain confident that the leadership team has a credible plan and the competence to execute it. Should is the key word. The problem I see with insurance coverage is that we can switch companies. Why would any one company worry too much about long term complications since many of those may not hit until we reach Medicare and then it’s the government’s responsibility. But government sponsored insurance should be interested in the long term since we’ll all be there some day.
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