Hi @Fastback6666,
yes, it’s compelling adult EAP data for you & me.
But no, IMO the FDA will want another trial - at least on the go - for approval purposes. Could we get AA? Maybe, but a case needs to be at least acknowledged by the FDA before pursuing it. I don’t recall seeing any FDA support for an adult AA.
Best case as I see it will differ on MSBs desired strategic position in the aGVHD market - if it’s 1st line or 2nd line, then the trial will be required & assessment vs Rux will be necessary. If 3rd line, then EAP may be good enough.
But it won’t be good enough IMO for BMT CTN. They want to see the cells go head to head vs the small molecules. So do I.
Cheer up. Off-label post-paediatric approval will boost MSB sales revenue in the meantime. All those physicians know the cells work too. And there’s always the prospect of early completion.
Cheers
Hi @Fastback6666,yes, it’s compelling adult EAP data for you &...
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