FDA Indicates Adequate Data For Mesoblast's Remestemcel-L BLA Submission In Children With SR-aGVHD
(RTTNews) - Mesoblast Limited (MESO, MSB.AX) said 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 or BLA for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Mesoblast stated that it intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues.
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