I simply note the lack of specifics in the announcement about the FDA's response.I happen to think that a 3rd CRL is quite possible. SI's optimistic statements and confidence have been completely misplaced multiple times in the past. All I see is that the FDA told Mesoblast that if they resubmit the BLA they will reassess it again. That's not worth the risk of investing my money given all the previous randomised controlled clinical trials have failed to confirm efficacy. You be you, I'll be me ..
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-216
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