@stockrock one more thing...
Given the Priority Review pathway, could the FDA have given the "full" approval with conditions anyway?
Yes, I understand the subtlety between a "full" approval with conditions and a conditional approval (via the Accelerated Approval pathway)...
But, could the FDA have said - approval only for kids 12 and under, and Mesoblast must conduct a P4 Confirmatory RCT on adults?
OR is the CRL is only pathway to achieve this conditional approval?
(sorry, we've been down this discussion before, I'm just trying to close it out in my head)
MSB to dispute FDA finding in Type A meeting, page-597
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