September 2023, MSB announcement
March 2024. MSB meets with FDA regarding potency data.
March 2024. MSB says they have feedback from FDA, and
"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)."
So the assay prevented the study from being adequate. MSB provided more assay data and had a meeting with FDA about assays. Now the FDA says the study appears sufficient to support resubmission.
Could it be that FDA's review of the new assay data has led them to look more favorably upon the study?
Just connecting dots.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-997
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