I reluctantly concur.
I cannot understand his logic on the CC today - intimating they knew that a trial in adults would always be required. FFS!
He said after the last CRL they had an adult trial protocol ready to go (offered that at ODAC as well) and he expected to have that CRL sorted out in 6 months ! Muppet! FOS!
Bottom line is that no approval will be granted for remestemcel until it gets administer in another trial with appropriate results from that trial.
As for an AA for children following a type A meeting - how could anybody be foolish enough to suggest that given the BLA for children has just been tossed.
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