Hi @Zenox, it was logical and the right thing to do by Mesoblast in aiming for a full approval, as was evidence by the ODAC 9-1 vote.
Obviously, the FDA in their wisdom decided to go against ODAC almost unanimous vote
Who knows what goes on behind closed doors, but on the surface this FDA decision looks ridiculous based on precedents or any other measure we care to compare against
Anyway, FDA decision made - so we can only look forward to the CRL Type A request.
Bring it on!
BTW - I'm reserving your services for future analysis - stay tuned
MSB to dispute FDA finding in Type A meeting, page-394
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