@ddwn
" CRL did not question the efficiency of the product as was demonstrated in GVHD001 "
well not directly, but kinda sorta - in that they seem to accept that the potency assay for the current product is valid but that they aren't comfortable that the potency assay for the current product is the same as for the product used in the trial that proved efficacy.
so in other words, we are back at the point where they said (originally) that the issue with the trial - and by extension potency assay - was not that when it was effective it was effective, but that when it was NOT effective was it because the batch didn't work or wasn't as potent?
which is kind of efficacy in a way.
Mesoblast CC Transcript 31/8, page-14
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