Jul. 29 at 12:45 PM
$ALLO RMAT is only granted when preliminary clinical evidence shows the therapy may address an unmet medical need.For cema‑cel, FDA explicitly based this on the ALPHA3 futility analysis . FDA is signaling "We think this early signal is real" This is another derisking factor. RMAT now combines for Fast Track which means more frequent meetings, eligibie for AA, a rolling BLA review(sections can be submitted as ready), and potentially a priority review. If Alpha 3 achieves MRD clearance and EFS (mid 27), FDA could grant AA, and then ask for a confirmatory study. Opinion only.
