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Post by goyocafe on Feb 26, 2021 17:06:05 GMT -5
Afrezza Pediatric Phase 3 clinical trial commencing this year, folks. Where is the excitement?!? I'll believe it when I see it. |
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Post by mango on Feb 26, 2021 18:16:54 GMT -5
Afrezza Pediatric Phase 3 clinical trial commencing this year, folks. Where is the excitement?!? I'll believe it when I see it. Oh, it’s happening.  |
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Post by celo on Feb 26, 2021 19:39:22 GMT -5
So what's a good timeline. Pediatric trial starting in November then how long to complete? Approval a year after completion?
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Post by Clement on Feb 26, 2021 19:49:26 GMT -5
So what's a good timeline. Pediatric trial starting in November then how long to complete? Approval a year after completion? Didn't Mike say then 3 years to launch? |
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Post by radgray68 on Feb 26, 2021 21:10:05 GMT -5
About 6 months to a year to enroll. One year trial duration. Launch in 2024 is what i heard. So many other good things can happen before then that it has been reduced in importance for me.
Hopefully, the doctors will follow the aggressive titration protocols. If they do, we can still come out okay. This trial is 26 weeks instead of the short 12 week ones we've done. Also 250 enrolled should have over 200-220 patients finish. That should be long enough to allow us to get their A1c levels down to what I'll coin as "Afrezza levels."
I was encouraged a little today by Mike's comment in the SVB Leerink conference about insisting on the tighter titration with the FDA so as not to get another 'Half-assed" trial.
I just want a fair chance to show superiority. You know, the way Al Mann envisioned Afrezza to be. (before the FDA and Sanofi crapped all over his baby)
Can you guys imagine that any children, after inhaling their insulin for a year, would want to go back to needles?
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Post by mango on Feb 26, 2021 22:46:44 GMT -5
About 6 months to a year to enroll. One year trial duration. Launch in 2024 is what i heard. So many other good things can happen before then that it has been reduced in importance for me. Hopefully, the doctors will follow the aggressive titration protocols. If they do, we can still come out okay. This trial is 26 weeks instead of the short 12 week ones we've done. Also 250 enrolled should have over 200-220 patients finish. That should be long enough to allow us to get their A1c levels down to what I'll coin as "Afrezza levels." I was encouraged a little today by Mike's comment in the SVB Leerink conference about insisting on the tighter titration with the FDA so as not to get another 'Half-assed" trial. I just want a fair chance to show superiority. You know, the way Al Mann envisioned Afrezza to be. (before the FDA and Sanofi crapped all over his baby) Can you guys imagine that any children, after inhaling their insulin for a year, would want to go back to needles? Kids absolutely hate needles as do many adults, including myself. They’ll never use another injectable prandial again. Furthermore, parents will be able to rest easy knowing the safety profile is significantly better with Afrezza compared to all subcutaneous prandial insulins. Not to mention, no localized insulin-derived amyloidosis to worry about and all the other potential horrific adverse events. Peds approval will be a landmark for MannKind. |
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Post by sayhey24 on Feb 27, 2021 9:10:18 GMT -5
Mango - I sure hope you are right. I am really hoping the Mom's realize the safety profile and understand proper prandial and follow-up dosing with pump use.
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Post by cretin11 on Feb 27, 2021 10:50:47 GMT -5
Mango - I sure hope you are right. I am really hoping the Mom's realize the safety profile and understand proper prandial and follow-up dosing with pump use. This is a crucial point. And another reason we need VDEX at the forefront, as they are better suited to proper instruction for patients than what MannKind has been trying. |
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Post by prcgorman2 on Feb 27, 2021 12:25:46 GMT -5
To this day I’ve never seen a post that explained in credible detail what impact VDEX is having. I do give them credit for having made Afrezza a key focal point (still?) of their expertise in diabetes care. I am completely confident they’re helping our bottom-line, but neither they nor Mannkind are having any major impact in improving prescription rates. I don’t think it is any fault of their approach to diabetes care. I’ve become convinced it is what Matt, aged, and too many others have said; lack of good insurance coverage, lack of conviction amongst prescribers, and cost to the patients. I assume all of those can be addressed and Rx rates will materially improve. All it takes is time and money. I’m hopeful MNKD squeezes a few shekels out of the buoyant share price to put against those important headwinds on Afrezza sales. And, I hope VDEX someday has 100s of clinics and that they are spectacularly successful. Best of luck to those hard working persevering VDEX employees and management.
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Post by prcgorman2 on Feb 27, 2021 12:28:41 GMT -5
Just realized hoping VDEX has 100s of clinics is not a good thing with respect to a lasting diabetes pandemic. I hope they are successful and able to branch out into other areas for the exciting day when diabetes is cured. Same for Mannkind.
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Post by agedhippie on Mar 2, 2021 17:21:33 GMT -5
Mango - I sure hope you are right. I am really hoping the Mom's realize the safety profile and understand proper prandial and follow-up dosing with pump use. I think new diabetics, kids or adults, are the best area for growth for Afrezza. Once people have established a regime getting them to change is hard. But, if I had been offered inhaled insulin at diagnosis I would have jumped at it. |
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Post by prcgorman2 on Mar 2, 2021 22:36:35 GMT -5
Welcome back Aged. I hope I can encourage you to post about the convertible bonds in one of the threads. I don’t even care if it is a negative spin. You’re good at reading, analyzing, and offering insights, and I appreciate it. I hope you and yours are well and stay that way. BR.
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Post by longliner on Mar 2, 2021 22:50:01 GMT -5
Welcome back Aged. I hope I can encourage you to post about the convertible bonds in one of the threads. I don’t even care if it is a negative spin. You’re good at reading, analyzing, and offering insights, and I appreciate it. I hope you and yours are well and stay that way. BR. And I was ready to trade him in for a GS upgrade....shame upon my house.  |
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