This aligns really well with my question to you & @stockrock
In formal processes, you can only evaluate & judge on the info at hand.
E.g. ODAC were not asked to vote on manufacturing, so they didn't, even though it was discussed
So with the BLA for GVHD, could the FDA have given a conditional approval, subject to confirmatory trial?
Or do they need to issue a CRL to facilitate this "conditional pathway"?
MSB to dispute FDA finding in Type A meeting, page-162
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