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clock Created with Sketch. 26/03/24
14:10
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Originally posted by JB1975
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What I'm reading - Mesoblast... today announced that the U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 Study MSB-GVHD00 1 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 the FDA are clear (*** we'll speaking for myself I think you and the MSB board have a bit of a history (two CRLs to two BLA's now) in reading clear patterns in previous communications but not showing those original documents - I grant not showing is not unusual most companies don't disclose communications from the FDA - and then acting, and then not getting the results that you thought were clearly to be expected) and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD" "Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues ".
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but in my opinion MSB could misunderstand what the FDA has said to them
(20min delay)