Hi @dachopper,
We’ve been told the protocol for the adult trial’s been submitted. No reason I can think of that it wouldn’t have been sought to be designed by BMT CTN to be both confirmatory to FDA’s expectations & able to support label extension to adults. But I’m chewing on @Stellowe’s good points re endpoints.
So are you thinking AA for the paediatric indication & not standard approval then?
Cheers
2024 Here we go again., page-459
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