Gotta wonder why this potency issue wasn’t addressed BEFORE the 2nd BLA application was presented. I can only assuage that the FDA has been playing a ‘cat & mouse’ game with mesoblast…….throughout the process a lot of virtue signalling about the therapy…head nodding…..everything is ‘reasonable….the welcome mat is out….until the moment of truth arrives for actual approval…..then that welcome mat morphs into a trapdoor that propels you into a myriad of dead end delay pathways.
Ann: Mesoblast Type A Meeting with FDA, page-7
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