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).
“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear
and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD,” said Mesoblast CEO Dr. Silviu Itescu.
Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining
product characterization issues.
Directors walking the talk
Reg- looking forward to a hot august night
Ann: Appendix 3Y for Eric Rose, page-30
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