@LopezIn my opinion, sr aGVHD is a T cell mediated condition...

@Lopez
In my opinion, sr aGVHD is a T cell mediated condition with particular emphasis on the role of TH1 (where interferon gamma is believed to play a role) and very importantly Th17 cells. I therefore believe that a supplementary potency assay will probably be required for ARDS because of additional immune pathways involved. I think Mesoblast has been well aware if this for some time. For CHF, i consider phagocytosis is a major factor in treatment efficacy, so an extra potency assay will also be required by the FDA for this condition because of the mechanism of action .
Whilst we have not yet crossed the finishing line, the PDUFA date may prove conservative. Many resubmissions are informed of outcomes months ahead of the guided PDUFA date . I am very confident that Mesoblast dealt with the outstanding issues. The FDA is increasingly using its “refusal to file” powers for submissions that do not cut the mustard. If I am right , Mesoblast should be extremely attractive to partners assuming we have release criteria acceptable to the FDA. First mover advantage would be huge in the emerging field of biologics. DYOR


https://www.frontiersin.org/articles/10.3389/fimmu.2021.761448/full