Somebody is taking the micky here! Pure and simple.
MSB has said it had addresses potency assay issues in the 001 trial and fed these to FDA with agreement they “appeared reasonable”.
Mind you Rose tied himself in a bit of a knot in one of the CCs with his “reverted” description of the assay works.
Now this BS - FFS
Ann: Mesoblast Type A Meeting with FDA, page-18
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