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Post by mango on Apr 9, 2021 12:36:01 GMT -5
Picture says it all. Afrezza is the safest insulin on the market and causes no lung damage, no localized insulin-derived amyloidosis, no lipohypertrophy. Just a super safe and effective mealtime insulin, folks.
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Post by sayhey24 on Apr 10, 2021 7:07:34 GMT -5
Mango - the results we always hoped for are becoming reality.
Six years use of afrezza and outstanding results. I no longer see predictions of exploding lungs from the naysayers. Al Mann's prediction of the greatest advance in 100 years for the treatment of diabetes is now reality. However, the problem still remains a marketing one. Maybe one day Mike will figure it out.
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Post by uvula on Apr 10, 2021 7:14:14 GMT -5
Mike knows what the problem is. We all know what the problem is. Anecdotal evidence is almost meaningless. Mnkd needs to pay for clinical trials to update the noninferior label. Maybe the pediatric clinical trials can be used to accomplish this?
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Post by sr71 on Apr 10, 2021 10:33:02 GMT -5
Mike knows what the problem is. We all know what the problem is. Anecdotal evidence is almost meaningless. Mnkd needs to pay for clinical trials to update the noninferior label. Maybe the pediatric clinical trials can be used to accomplish this? 100% agree. And I think that no one at Mannkind knows how to construct such a trial to prove superiority, which would require CGM's, A1c, TIR, and (perhaps most importantly) follow-up dosing. I think we all know who could help design such a trial (Bill at VDEX), but MC apparently won't talk to him.
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Post by longliner on Apr 10, 2021 13:08:49 GMT -5
On the shoulders of a giant. (clout wise) I don't believe VDex has the financial backing to battle BP. We have watched Mannkind fight this slippery slope for years. I believe the knowledge and technology (CGM) now exists between the Afrezza advocates to work with a BP to prove superiority in a trial setting. I think both VDex and Mannkind would welcome that partnership / collaboration if it were offered to them.
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Post by sr71 on Apr 10, 2021 14:11:41 GMT -5
I believe fighting BP is to pick the wrong battle. Afrezza would have a far better chance of realizing its full potential in the marketplace with a well-designed trial by a team that could include not only MNKD and VDEX, but perhaps academic partners and non-profit organizations as well that share a commitment to truly improving quality of life for diabetics.
It's been my sad realization over the past several years that BP has nothing to gain (and plenty to lose with their existing insulins/analogs) by promoting the advancement of Afrezza. Case in point: Sanofi.
The only way to prove Afrezza superiority is without involvement by BP. In this way, only the FDA would need to be satisfied with the trial design. At this point it does not make sense to be reliant on decision-making process in a BP C-Suite that might only be pretending to share the goal for the future of Afrezza.
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