it is possible I have missed some of the FDA meeting outcomes, so I’d welcome your opinion as to how you foresee MSB getting g approval for something in the next 12 months
last I was aware, the CRL for GVHD required a new trial
and given none of the primary endpoints were met iny tothe heart or CLBP trials it would be very unlikely to FDA approval without confirmatory trials there too
that all seems more than 12 months away to me
happy to be corrected though
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