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Post by cretin11 on May 3, 2024 22:06:20 GMT -5
As aged said, suing the ADA is not an option because it is a non-governmental entity providing advice that everyone can follow or ignore as they choose. The safety aspect of Afrezza is nice but unfortunately does not alter that dynamic.
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Post by prcgorman2 on May 3, 2024 22:17:13 GMT -5
100% disagree, I think. I’m not saying that MannKind should storm into ADA and claim everyone there are liars and sue their industry association. I’m saying do what can be done with what’s been learned, but maybe just to Hell with “superiority”. If MannKind can prove “superiority” of Afrezza prandial insulin over other alternitives, cool, do it. But if that’s really, really hard, then so what? Beat the competition on SAFETY!!! Think about it. What is it doctors are taught about prescribing insulin? Be afraid! Be very very afraid! SAFETY (SAFETY, SAFETY,...) has VALUE. I’m an investor, but I believe MannKind’s Afrezza is head and shoulders above the competition when it comes to SAFETY with respect to hypoglycemia.
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Post by sayhey24 on May 4, 2024 6:27:54 GMT -5
... Ages tells us its a voluntary guide which is kind-of but not really true. More important it dictates insurance coverage. With Inhale-1,2 and 3 we can fix the label. With Inhale-1,2 and 3 I would hope we can make some progress with the SoC. To fix the cost we have to fix the insurance coverage which will only change when the SoC changes. The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) And INHALE-2 was published 10 years ago. If that was going to change the SoC it would have done so by now! Wow 10 years ago? I thought Inhale-2 just completed in India. Mike said he was expecting to see 1.5-2% reduction. I don't know if it was achieved but it would be big news if it was. The 175 did not show a 2% reduction but it was under dosed. How long after CGMs appeared front and center in the SoC did they get insurance coverage? It felt like the next day. As Dave Kendall said once you are SoC, insurance will come.
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Post by agedhippie on May 4, 2024 9:31:20 GMT -5
The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) ... What about lawyers making a case against the insurers? Has MNKD presented enough data to bolster the argument that it deserves the same or equal to the coverage other insulins receive and Insurers are failing to make the comparison and same conclusion? What is their case to defend their decision..."Other options are available that already address that need?" Well, that is the basis for MNKDs argument...it's the same as what is already covered but an inhaled form. Seems the first step is to get the coverage..then, later, say we are better. The insurers will point at their panel and say that the panel has evaluated the evidence. The panel will say that the only meaningful evidence they have at this time is the Phase 3 trial from ten years ago where Afrezza was non-inferior and therefore equivalent. The form of the drug (inhaled, injected, or oral) is irrelevant to the outcome and therefore has a low weight. Seriously, this is on MNKD. The Phase 3 trial is there to see if the drug works at scale and at least matches what is already there. This is why there are post-approval trials to improve the label, but MNKD did not do those. Trial data is everything in this world and INHALE-1 is a step in the right direction. The problem for MNKD is that the only evidence they have for Type 1 that is fit for purpose is the original phase 3 trial. Since then it's just been small scale studies and those will not have any influence with the panel. The INHALE-1 trial is the first trial or study since that phase 3 trial ten years ago that a panel would look at.
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Post by agedhippie on May 4, 2024 10:37:24 GMT -5
100% disagree, I think. I’m not saying that MannKind should storm into ADA and claim everyone there are liars and sue their industry association. I’m saying do what can be done with what’s been learned, but maybe just to Hell with “superiority”. If MannKind can prove “superiority” of Afrezza prandial insulin over other alternitives, cool, do it. But if that’s really, really hard, then so what? Beat the competition on SAFETY!!! Think about it. What is it doctors are taught about prescribing insulin? Be afraid! Be very very afraid! SAFETY (SAFETY, SAFETY,...) has VALUE. I’m an investor, but I believe MannKind’s Afrezza is head and shoulders above the competition when it comes to SAFETY with respect to hypoglycemia. The problem with the safety argument for Type 1 is that the Phase 3 trial found that while the reduction in hypoglycemia was greater in absolute terms it was not statistically significant so it cannot be claimed. MNKD published a correction to their original release for this - investors.mannkindcorp.com/news-releases/news-release-details/correcting-and-replacing-mannkind-reports-positive-data-phase-3. That is not to say that I personally think you won't have few hypos with Afrezza, it's just that you cannot prove it. To explain this; what they are looking at is the number of participants who had hypos, and then the difference between the two compared to the number of participants. Since the number having hypos is small the difference between the two will be even smaller meaning that relative to the total number of participants it falls within the margin of error. Statistical significance matters because it tells you where you should care or if it might just be noise.
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Post by prcgorman2 on May 4, 2024 11:39:13 GMT -5
I wasn’t suggesting MannKind try to claim SAFETY differentiation based on existing trial data. I assumed it would or might require a safety trial. And I’m not overly anxious about this because I’m no longer overly concerned about Afrezza sales. I do think a safety trial would be a good next step to improve the marketability of Afrezza.
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Post by cretin11 on May 4, 2024 12:06:58 GMT -5
Kudos prcgorman for showing in your previous post that you are able to type safety without using all caps 👍🏼😉
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Post by agedhippie on May 4, 2024 13:00:48 GMT -5
I wasn’t suggesting MannKind try to claim SAFETY differentiation based on existing trial data. I assumed it would or might require a safety trial. And I’m not overly anxious about this because I’m no longer overly concerned about Afrezza sales. I do think a safety trial would be a good next step to improve the marketability of Afrezza. In that case yes. An easy way to do this would be to collect existing CGM data from Afrezza users, pool it and compare that with a pool of CGM users using RAA. The pools would need to be big to avoid bias, but in principle you could do it purely off analysis. This would be relatively quick provided (a big if) you could get the CGM data. This is what Medtronic did recently with data from their 780G AID pumps although in their case it was easier because they already had all the data.
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Post by sayhey24 on May 4, 2024 17:33:47 GMT -5
What about lawyers making a case against the insurers? Has MNKD presented enough data to bolster the argument that it deserves the same or equal to the coverage other insulins receive and Insurers are failing to make the comparison and same conclusion? What is their case to defend their decision..."Other options are available that already address that need?" Well, that is the basis for MNKDs argument...it's the same as what is already covered but an inhaled form. Seems the first step is to get the coverage..then, later, say we are better. The insurers will point at their panel and say that the panel has evaluated the evidence. The panel will say that the only meaningful evidence they have at this time is the Phase 3 trial from ten years ago where Afrezza was non-inferior and therefore equivalent. The form of the drug (inhaled, injected, or oral) is irrelevant to the outcome and therefore has a low weight. Seriously, this is on MNKD. The Phase 3 trial is there to see if the drug works at scale and at least matches what is already there. This is why there are post-approval trials to improve the label, but MNKD did not do those. Trial data is everything in this world and INHALE-1 is a step in the right direction. The problem for MNKD is that the only evidence they have for Type 1 that is fit for purpose is the original phase 3 trial. Since then it's just been small scale studies and those will not have any influence with the panel. The INHALE-1 trial is the first trial or study since that phase 3 trial ten years ago that a panel would look at. I think you raise a good point. In light of the Inhale-3 results the panel should revisit the 171. In the 171 we know in most cases it was underdosed but showed non-inferiority. We also know when certain testing centers properly dosed their results were so outstanding the FDA review team accused them of cheating. I would say the Inhale-3 re-enforces the 171 findings and they should be re-looked at in that light. When properly dosed we have superiority and when under dosed its still that good that we have non-inferiority. Now that is damn good.
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Post by letitride on May 4, 2024 19:16:51 GMT -5
The real needle mover is Afrezza and its so huge most cant see it like seeing the forest for the trees but its still moving.
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Post by ktim on May 5, 2024 17:21:23 GMT -5
The real needle mover is Afrezza and its so huge most cant see it like seeing the forest for the trees but its still moving. Glad to see not everyone has given up the hopium. Maybe you need to pass the hopium pipe to MNKD management. Their released guidance for Afrezza revenue is rather lackluster going all the way out to 2030. It's not where they expect the majority of our growth will come. Maybe you're right and they are wrong.
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Post by letitride on May 5, 2024 19:47:27 GMT -5
MC is making all the right moves with Afrezza waiting on the trials to affirm what he needs to move this needle. TDPI is opening the gates for this ship to sail. When you add Clofazimine and Nintedinab its the makings of a monster Bio Tech.
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Post by mymann on May 5, 2024 20:33:02 GMT -5
One step at a time. I just want to see sp stay above $5 rest of the year. I use to have big dreams about Afrezza but realized "hope is a dangerous thing my friend". I have gotten Instutionalized.
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Post by cretin11 on May 5, 2024 21:01:26 GMT -5
MC is making all the right moves with Afrezza Words I never dreamed of seeing, but would love them to be true one day 🤷🏽♂️🙏🏽
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Post by letitride on May 5, 2024 22:54:21 GMT -5
Keep dancing one day you may live the dream you would love to be true.
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