Hi @Dowski,
re " Is it possible that they're only going to run the adult trial if the resubmission fails? "
no, I don't think it's possible at all. And MSB has been crystal on that.
However, I think our advisors are saying to us now let's wait for the Minutes, and see whether the bureacrats try to slip more weasel words in at the last minute - and, if so, deal with that first.
Remember, it's the Minutes which are the definitive record. And, if one were BMT CTN, and knew how, shall we say, politically malleable FDA principles have proved to be in recent times, then BMT CTN's preferred CRO would probably want to wait a little longer too before commencing to enact the protocol.
Cheers
2024 Here we go again., page-450
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