@OP, We talk a lot about accelerated approvals. The even better news is that with the Regenerative Medicine Advanced Therapy (RMAT) designation, the FDA provides what I think of as “concessions” (further to the use of surrogate endpoints) on the confirmatory evidence for accelerated approval where serious conditions are involved:
See above excerpt from its 2019 guidance on
”Expedited Programs for Regenerative Medicine Therapies for Serious Conditions”.
https://www.fda.gov/media/120267/download
A little bit above the excerpt, you will see in the original document by going to the link, how even the use of surrogate end points is just one of two pathways to accelerating approval of regenerative therapies that have been formally granted the RMAT status.
Rexlemestemcel, I understand, has been granted RMAT status.
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