Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-569

U.S. FDA has informed the company that following additional consideration the
available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of
the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients
with steroid-refractory acute graft versus host disease (SR-aGVHD).


Hi JB,
I said permission to refile- my words.
FDA has said appears sufficient to support submission. The submission process having being stopped by the FDA, now " following additional consideration" the process may continue.

I will say you are correct to challenge my use of the word permission. The company could have refiled anytime and likely have been refused.

However it appears that a stumbling block in the process has been resolved.

The stumbling block imo is agreement that the potency data presented has merit- but now needs to be considered in the BLA resubmission.

Reg