The potency assay was clearly stated in the CRL announcement as the issue. This should come as no surprise to anyone. Issue for me is that the adult trial can't start, or even the trial design get approved, until the potency assay is agreed to by the FDA. If the new data cut it then pediatric approval could be on the cards pre adult trial. There is the potential for MSB to remain solvent without dramatic action if they can nail the potency assay in the next few months.
Ann: Mesoblast Type A Meeting with FDA, page-5
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