banter and General Discussion, page-10163

If any of what @JB1975 or yourself are saying were remotely true, then the FDA wouldn't have asked Mesoblast to refile the BLA for Remestemcel-L for the treatment of sr-GVHD ... the FDA would have simply said "that's great Silviu et al" now go away and conduct the adult trial you have planned with the BMT and substantiate the data / potency assay and come back to us with the results when it is finished. Instead in March 2024......



"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)"







..... but then again @JB1975 and yourself (amongst others) have argued with me for 2 years that the FDA would never entertain an Accelerated Approval pathway for Rexlemestrocel-L for CHF and yet here we are awaiting the pre BLA submission FDA meeting for same:






GLTAH