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Post by brotherm1 on Mar 22, 2018 9:53:35 GMT -5
What I don't see is where these 65 studies are since only 47 are listed in the Clinical Trials site for all Mannkind trials including the non-Afrezza ones and abandoned trials. Things like the hypo results from the Type 1 trials matter and I never understood why they were not used. What we need is a new superiority trial. That's what will move sales. Our recent label change granted by the FDA last fall - non-inferior PK/PD profile - was it granted based upon a particular clinical study that MNKD did specifically for the purpose of that label change? Does anyone recall? |
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Post by peppy on Mar 22, 2018 9:56:53 GMT -5
What I don't see is where these 65 studies are since only 47 are listed in the Clinical Trials site for all Mannkind trials including the non-Afrezza ones and abandoned trials. Things like the hypo results from the Type 1 trials matter and I never understood why they were not used. What we need is a new superiority trial. That's what will move sales. Our recent label change granted by the FDA last fall - non-inferior PK/PD profile - was it granted based upon a particular clinical study that MNKD did specifically for the purpose of that label change? Does anyone recall? I recall. here is the basis for the data change. www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdfLiane allows me to stash this stuff in resources. Thank you liane. |
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Post by brotherm1 on Mar 22, 2018 11:38:22 GMT -5
Thanks Pep. It was the 4 month clamp study completed Sept 2015. Took two years from then to the label change
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Post by peppy on Mar 22, 2018 11:59:16 GMT -5
Thanks Pep. It was the 4 month clamp study completed Sept 2015. Took two years from then to the label change Sanofi did the study. The only after approval work they did. we did not get the clamp study back from Sanofi until some end date after the drop. we got the label change as fast as we could once MNKD got the study. (just more Sanofi sabotage data) |
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Post by radgray68 on Mar 22, 2018 19:26:01 GMT -5
Well, IMHO...
Al knew what he had and so did all the other thought leaders. The information is there in those 60 studies. I believe Al may have had several buyers lined up before the first CRL. Leading up to the actual approval, our market cap of $4 billion hinted at the market expecting a buyout soon after, again IMO, but that was Al's MO. The kibosh was put on any sale when the FDA put in their crippling restrictions. After that, prospective buyers, knowing that years of costly delay was in Afrezza's future, dropped their offers and ran. It just became easier and cheaper for big pharma to bankrupt us than buy us at that point.
Al had the guts and smarts to avoid selling cheap and take the long road. However, taking the long road required settling for a sub-optimal Sanofi deal. Al, not loving the day-to-day of ordinary business management, would have probably hired a better CEO for that challenge, but his health failed him before he could see it through, most unfortunately. Matt and Al were devoted employees but their education and experience left them just sorely unprepared for the kind of uphill, cage fight that is required to bust into the insulin cartel's business. The rest, as they say, is history.
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Post by agedhippie on Mar 23, 2018 9:49:22 GMT -5
Well, IMHO... Al knew what he had and so did all the other thought leaders. The information is there in those 60 studies. I believe Al may have had several buyers lined up before the first CRL. Leading up to the actual approval, our market cap of $4 billion hinted at the market expecting a buyout soon after, again IMO, but that was Al's MO. The kibosh was put on any sale when the FDA put in their crippling restrictions. After that, prospective buyers, knowing that years of costly delay was in Afrezza's future, dropped their offers and ran. It just became easier and cheaper for big pharma to bankrupt us than buy us at that point. Al had the guts and smarts to avoid selling cheap and take the long road. However, taking the long road required settling for a sub-optimal Sanofi deal. Al, not loving the day-to-day of ordinary business management, would have probably hired a better CEO for that challenge, but his health failed him before he could see it through, most unfortunately. Matt and Al were devoted employees but their education and experience left them just sorely unprepared for the kind of uphill, cage fight that is required to bust into the insulin cartel's business. The rest, as they say, is history. I agree with almost all of that. I don't subscribe to the BP conspiracy theory though which I know puts me in a minority. BP dropped out because success became uncertain with the FDA prevarications. At that point the sensible thing is to withdraw and see how it played out. You don't have to buy a company at it's lowest possible price, it is often better to wait until it is visibly recovering before you launch a bid. That way, for a cost, you dramatically reduce your chances of buying a dud (like Pfizer and Exubera). Small companies need one blockbuster, BP needs a stable of solid performers (although blockbusters are nice as well). |
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Post by peppy on Mar 23, 2018 10:14:27 GMT -5
Well, IMHO... Al knew what he had and so did all the other thought leaders. The information is there in those 60 studies. I believe Al may have had several buyers lined up before the first CRL. Leading up to the actual approval, our market cap of $4 billion hinted at the market expecting a buyout soon after, again IMO, but that was Al's MO. The kibosh was put on any sale when the FDA put in their crippling restrictions. After that, prospective buyers, knowing that years of costly delay was in Afrezza's future, dropped their offers and ran. It just became easier and cheaper for big pharma to bankrupt us than buy us at that point. Al had the guts and smarts to avoid selling cheap and take the long road. However, taking the long road required settling for a sub-optimal Sanofi deal. Al, not loving the day-to-day of ordinary business management, would have probably hired a better CEO for that challenge, but his health failed him before he could see it through, most unfortunately. Matt and Al were devoted employees but their education and experience left them just sorely unprepared for the kind of uphill, cage fight that is required to bust into the insulin cartel's business. The rest, as they say, is history. I agree with almost all of that. I don't subscribe to the BP conspiracy theory though which I know puts me in a minority. BP dropped out because success became uncertain with the FDA prevarications. At that point the sensible thing is to withdraw and see how it played out. You don't have to buy a company at it's lowest possible price, it is often better to wait until it is visibly recovering before you launch a bid. That way, for a cost, you dramatically reduce your chances of buying a dud (like Pfizer and Exubera). Small companies need one blockbuster, BP needs a stable of solid performers (although blockbusters are nice as well). Have you looked at the continuous glucose monitor data? We do not have to be or act blind? we can see. Do we have to act like we do not have eyeballs? Asking for a friend.    |
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Post by agedhippie on Mar 23, 2018 12:28:39 GMT -5
I agree with almost all of that. I don't subscribe to the BP conspiracy theory though which I know puts me in a minority. BP dropped out because success became uncertain with the FDA prevarications. At that point the sensible thing is to withdraw and see how it played out. You don't have to buy a company at it's lowest possible price, it is often better to wait until it is visibly recovering before you launch a bid. That way, for a cost, you dramatically reduce your chances of buying a dud (like Pfizer and Exubera). Small companies need one blockbuster, BP needs a stable of solid performers (although blockbusters are nice as well). Have you looked at the continuous glucose monitor data? We do not have to be or act blind? we can see. Do we have to act like we do not have eyeballs? Asking for a friend. I have seen the CGM data, but it's a small sample of dedicated users. The reason it gets dismissed is because it is seldom scales once you get typical sloppy diabetics like me. This is a pump user's results for a week - near perfect results.  No way I have ever been near that good, but equally I would not expect to be anywhere near as good as the Afrezza graphs I see either. Simply, like most diabetics I snack between meals and don't bolus for everything that passes my lips (like this coffee I have in front of me  ) and endos know that so these graphs do not particularly impress them. If I didn't eat between meals, and bolused properly I could probably get near that graph as well. |
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Post by peppy on Mar 23, 2018 12:35:04 GMT -5
Have you looked at the continuous glucose monitor data? We do not have to be or act blind? we can see. Do we have to act like we do not have eyeballs? Asking for a friend. I have seen the CGM data, but it's a small sample of dedicated users. The reason it gets dismissed is because it is seldom scales once you get typical sloppy diabetics like me. This is a pump user's results for a week - near perfect results. No way I have ever been near that good, but equally I would not expect to be anywhere near as good as the Afrezza graphs I see either. Simply, like most diabetics I snack between meals and don't bolus for everything that passes my lips (like this coffee I have in front of me ) and endos know that so these graphs do not particularly impress them. If I didn't eat between meals, and bolused properly I could probably get near that graph as well. Quote; endos know that so these graphs do not particularly impress them. Reply: aged, what does impress the endo's ? (besides testosterone cream) |
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Post by matt on Mar 23, 2018 13:53:56 GMT -5
Quote; endos know that so these graphs do not particularly impress them. Reply: aged, what does impress the endo's ? (besides testosterone cream) To get results with Afrezza, or any other drug but especially Afrezza, it has to be used as described on the label. Most physicians simply accept that the vast majority of their patients will fail to follow instructions so if a drug is not forgiving on excursions from therapy then graphs like the ones above will simply not be believed. I have written clinical trial protocols requiring diabetics to have an HbA1c at or below 7 and was told by my investigators that enrollment would be extremely slow to non-existent at that hospital (a very large and well-respected university research center). We finally settled on an inclusion criterion of HbA1c <=8, but I still got a lot of push-back. Regardless, physician know that studies based on a small number of patients that are closely monitored under clinical trial conditions are not representative of results to be expected from large populations of patients that are not part of a study. Twenty years of experience as a physician treating patients that don't adhere to their prescribed treatment / exercise / diet regimen is always going to outweigh a salesmen waving the results of a new study. So what does impress endos? Frankly not much. |
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Post by agedhippie on Mar 23, 2018 13:59:06 GMT -5
Quote; endos know that so these graphs do not particularly impress them. Reply: aged, what does impress the endo's ? (besides testosterone cream) Data from large scale well conducted trials (and testosterone cream, separately or together). The ADA evidence weighting is a good guide: The best -
Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including : - Evidence from a well-conducted multicenter trial - Evidence from a meta-analysis that incorporated quality ratings in the analysis Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at the University of Oxford [ This would require a cure of diabetes] Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including : - Evidence from a well-conducted trial at one or more institutions - Evidence from a meta-analysis that incorporated quality ratings in the analysis Important but not necessarily compelling - Supportive evidence from well-conducted cohort studies - Evidence from a well-conducted prospective cohort study or registry - Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study |
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Post by mnholdem on Mar 23, 2018 14:37:40 GMT -5
Saveth managed to impress the head endocrinologist at a hospital and he is one guy with a CGM and Aftezza. Impressed enough that the physician has scheduled a trip to visit MannKind Cororation to learn more.
The challenge is to get many more endos to see the results but it's true that the label plays a big part in doctor's assessing a new treatment.
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Post by sportsrancho on Mar 23, 2018 15:31:53 GMT -5
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Post by sayhey24 on Mar 23, 2018 17:38:19 GMT -5
North Shore University Hospital would be a nice "Afrezza Center of Excellence". I think its the teaching hospital for NYU.
How crazy would it be that the big break afrezza gets is because of heart surgery by one of its users.
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Post by agedhippie on Mar 23, 2018 18:36:58 GMT -5
North Shore University Hospital would be a nice "Afrezza Center of Excellence". I think its the teaching hospital for NYU. How crazy would it be that the big break afrezza gets is because of heart surgery by one of its users. NYU is the teaching hospital for NYU  North Shore University Hospital is part of Northwell. Their Manhattan hospital is Lennox Hill which is a nice hospital whose ER is seldom as badly crowded as most. |
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) and endos know that so these graphs do not particularly impress them. If I didn't eat between meals, and bolused properly I could probably get near that graph as well.
