Agree @ddwn with your question. Would MSB have been in discussions with FDA since ODAC? Obvious FDA don’t have the knowledge, let alone the understanding of the science related to stem cells. FDA flexing their muscle (or needing extra time) or needing to look like they are being extra vigilant! Last minute delivery of the CRL makes me think this is just an added step in the road.
MSB to dispute FDA finding in Type A meeting, page-90
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