"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)."
If you cant see this as a very strong FDA olive branch, and because there is no other treatments for this, then you shouldn't be an investor, not you Col but others. How will the FDA look, now with that acceptance of the data, but probably more of these dying children, if they were to knock it back again, after encouraging it to be re submitted?
The FDA would lose all credibility if Mesoblast has correctly and honestly described their encouragement to re submit, but then didn't approve a 3rd time.
banter and General Discussion, page-10172
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