Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-235

JB1975- the NEW DATA is not available in the public domain. You were correct - well done- on predicting the CRL.
All we know is below. I believe you had cast doubt upon Prof Kurtzbergs potency assay- what would have needed to be added to give you certainty? Can you predict what they may have achieved scientifically?
Something has changed- that's a fact



New data from second potency assay provided to FDA, meeting scheduled Q1 CY2024.

Graft versus Host Disease – Pediatric and Adult Indications
• United States Food and Drug Administration (FDA) informed Mesoblast after its Type C meeting
during the quarter 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).
• Mesoblast intends to file the resubmission this quarter, potentially resulting in an approval for
Ryoncil® (remestemcel-L) in the second half of CY2024.
• Mesoblast will now focus on its original strategy to first gain pediatric approval for RYONCIL, followed
by label extension in the larger adult population.


Reg