@Dimasq10 - no disrespect taken, there's definitely room for a range of views on this one given no one has seen the CRL, and the unusual move to go against the ODAC recommendation... anything is in play, and all you can do is look at the evidence and make a call about what might happen. I agree with you entirely about Covid, it's a game changer for Mesoblast even if they're not remotely close to being first to market because the covid emphasis accelerates approval for non-Covid ARDS, gets through the regulatory BS quicker, and puts revenue on the books sooner.
Imagine GVHD was CRL'd and we had secondary phase 3 trials for CHF and LBP coming up... we'd be years away from a product! (could still happen if we fail the Covid phase 3 but that seems unlikely).
MSB to dispute FDA finding in Type A meeting, page-369
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