No it doesn't make any sense. I think maybe Mesoblast could explain. FDA knew right at the start the trial was a single arm and still accepted the BLA and now turned around and issued a CRL demanding a RCT despite overwhelming evidence of efficacy through trial and EAP and a 9-1 ODAC vote! And it has been currently successfully used in Japan the past 4 years, though I know FDA does not give a damn what other regulatories do.
I struggle to understand this myself.
MSB to dispute FDA finding in Type A meeting, page-335
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