This is what MSB says and i've highlighted the relevant parts.
The filing comes after Mesoblast was informed by FDA at the end of March that, following additional
consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to
support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SRaGVHD. As a result, the filing addresses remaining CMC (Chemistry, Manufacturing, and Control) items.
No one here and this includes you, know the specific potency assay components. MSB has addressed it as requested by the FDA. Now we wait and see if MSB has done a good job at that!
50/50 bet. You either will come out as a smarty pants or we all show you the door. (it's obvious you don't know where the door is lol)
banter and General Discussion, page-10150
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