FDA August 2023:Melbourne, Australia; August 4 and New York,...

FDA August 2023:

Melbourne, Australia; August 4 and New York, USA; August 3, 2023: Mesoblast Limited
(ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases,
today announced that the US Food and Drug Administration (FDA) has provided a complete response to
its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric
steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more data to support
marketing approval. To obtain the data required, Mesoblast will conduct a targeted, controlled study in
the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial
strategy, which envisioned a sequenced progression from pediatric to adult SR-aGVHD indications.
Adults comprise 80% of the SR-aGVHD market.


FDA March 2024:

Melbourne, Australia; March 26 and New York, USA; March 25, 2024: Mesoblast Limited
(ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases,
today announced that 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).

I don't think the FDA even knows what it wants, and unfortunately the adult trial has not started - not that it would have done any good as FDA could simply ask for more data again regardless of end points being met.