Yes the OTAT meeting is for aGVHD but SI has said it can cross reference since it's the same cell. So this meeting is relevant for all implications for Remestemcel not just for aGVHD.
See below:
"FDA indicated that potency assays must be established and agreed prior to commencement of the
proposed Phase 3 clinical trial" <- Covid-19 ARDS
"Mesoblast has an upcoming meeting with FDA’s OTAT regarding potency assays for remestemcel-L in
relation to SR-aGvHD, attributes which we believe to be also relevant to COVID ARDS"
Yes the OTAT meeting is for aGVHD but SI has said it can cross...
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