https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track#:~:text=Fast%20Track%20designation%20must%20be,need%20in%20a%20serious%20condition.
in response to Dan's question. Hope that helps.
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-31
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