Thanks Pfeifer. Just to reiteratre, I actually said "I think an accelerated approval on a phase II trial with a possible phase III confirmatory trial as a condition, a very real possibility." Never a certainity. A possibility.
YOu have shown yourself, many DFU's amputation are perhaps unnecessary with quick intervention and the possibilities for novel therapies to step in where prevention too late and the only alternative amputation, will not go dismissed by the FDA. There were 71 new medicine approvals in 2023:
5 novel gene therapies, including the very first CRISPR–Cas9-edited cell therapy — Vertex Pharmaceuticals and CRISPR Therapeutic.
On too many threads on Hot Copper the FDA is painted as this monolith stuck in the past. Its anything but:
https://www.raps.org/news-and-articles/news-articles/2024/1/fda-eyes-collaborative-review-pilot-for-gene-thera
https://pink.citeline.com/PS149861/Accelerated-Approval-Now-Starting-Point-For-Gene-Therapy-Development-US-FDAs-Marks-Says
The FDA is trying to let this stuff to market through less onerous routes, whilst maintaining the integrity of its processes, rather than the old lengthy processes, understanding the expense and difficult economics. Marks says it openly, in gene therapies particularly, AA are the starting point in many of these urgently needed treatments, not the exception. Its equally not failing to act when confirmatory phase III trials fail too reinforce phase II efficacy insights to maintain the integrity of its processes.
https://pink.citeline.com/PS149842/Accelerated-Approval-US-FDAs-Hammer-Falls-On-Oncopeptides-Pepaxto
The landscape is changing. Like most MSB shareholders, I am convinced MSB is finally on the cusp. And the landscape changes again if it gets approved. And CYP's prospects with it.
This was the watershed speech from Marks and the flood gates, on gene therapies particularly, have since opened:
https://www.fiercebiotech.com/biotech/peter-marks-says-fda-now-has-better-sense-rare-disease-biomarkers-will-more-accelerated
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