I raised with the company by email in early Feb the below guidance. It is extremely interesting, in that it highlights on p.10 the circumstances, under the relevant section of the FD&C Act, as added by the Cures Act, whereby RMATs may be eligible for accelerated approval, based on either (1) pre-agreed surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; OR (2) reliance on data from a meaningful number of sites. The DREAM trial involved over 50 sites, so this is definitely something that could have been raised with the FDA in the very recent adult HF meeting with the FDA on Revascor, which has the RMAT (Regenerative Medicine Advanced Therapy) designation.
https://www.fda.gov/media/120267/download#:~:text=2%20Under%20section%20506(.g,therapy%E2%80%9D%20(RMAT)%20designation.
I raised with the company by email in early Feb the below...
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