Dealmin, it was a stretch by OP to assume something similar was not in place. That information is not public.
You can bet MSB have used their learnings from the CRL and applied them to CHF, which should have already been using a matrix approach ( multiple assays. )
And assays linked to survival outcomes . Si said this was critical for all indications last year- pre BLA resubmission.
I would assume, if they have something, they will take it with them to the FDA , and it would be taken into consideration.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-230
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