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exwannabe

12/04/21 12:42 PM

#423802 RE: biosectinvestor #423743

Also, they do not need TLD to get RMAT, but manufacturing capacity, while not a requirement might be important to the FDA as any accelerated status will potentially put them in line to be the new standard of care.


They do not need P3 data for any of Fast Tract, BTD or RMAT. These programs are intended to be applied for even before a P3 starts.

And they do not need manufacturing for any of them either.