See p.10 of this below FDA guidance for AA criteria for RMAT products ie. the top 2 bullet points on the page. Either one of 2 criteria needs to be satisfied. The second being reliance on multi-centre data. The completed randomised controlled Phase 3 DREAM trial on Revascor or Rexlemstrocel was based on 537 patients in over 50 centres. This is what
@aquazul referred to in his post. The remaining bullet point on p.10 about choosing a surrogate endpoint that is agreed with the FDA is what the upcoming meeting about (plus CMC and manufacturing issues as foreshadowed in the company’s recent announcement).
https://www.fda.gov/media/120267/download#:~:text=FDA%20refers%20to%20such%20designation,granted%20designation%20as%20an%20RMAT.
And we all know how eager and prepared Dr. Emerson Perin is in getting on with the confirmatory DREAM II trial.
(20min delay)