I don't think the GVHD trial will commercliale on a P2 alone. Where did I ever suggest that? Jeez, your misquoting knows no bounds.
Now the wider FDA changes to support the idea of accelerated approvals are extensive. Its an over-riding range of developmets, not least of which Marks discussing the need for quicker, less onerous approvals in biologics in areas where patients have no decent standards of care to prevent death or in DFU's case, crude amputations, that you are well aware of:
https://www.fiercebiotech.com/biotech/peter-marks-says-fda-now-has-better-sense-rare-disease-biomarkers-will-more-acceleratedThere are a range of treatements and drugs where the FDA has recently shown willingness for companies to commence what they are routinely calling phase II/III trials for approvals in more niche, rare disease and orphan designations where standard of care sorely lacking in efficacy:
https://**promotion blocked**/health/highly-encouraged-pharmaust-completes-pre-ind-meeting-with-us-fda/https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/Think you might need to check your research 'efficacy' too. For example:
"The “living drug” consists of tumor-infiltrating lymphocytes that can recognize and attack a patient’s specific cancer."
"The approval of Amtagvi is based on results from the C-144-01 trial (NCT02360579),
a multicenter Phase II study that enrolled patients with inoperable or metastatic melanoma."
https://www.cancerhealth.com/article/fda-approves-amtagvi-new-type-immunotherapy-melanomaSo no, I don think I am delusional (or Dr Kelly) in seeing some possibilities of accelerated approvals in both GvHD and DFU). Both may indeed still require confirmatory phae III studies, and I never said either would commercialise on a P2 alone - stop falsely atrributing statements to me I never said:
"150,000!!! [DFU amputations] That's massive. Nearly 1 in 2,000 US people get amputations a year from Diabetes in the US, which is obviously rife. I think an accelerated approval on a phase II trial with a possible phase III confirmatory trial as a condition, a very real possibility."
(20min delay)