This is where I'm at...
If post ODAC and the FDA & Mesoblast were in discussions, surely conditional approval would have been discussed... and if so, dismissed.
Then FDA issued a CRL, only for Mesobladt to chase a conditional approval?
It just doesn't add up.
My only conclusion is that this CRL is the ONLY pathway for a conditional approval
MSB to dispute FDA finding in Type A meeting, page-237
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