Forgive the wish casting, but do these sentiments suggest one...

Forgive the wish casting, but do these sentiments suggest one outcome could see an AA granted on commencement/enrollment of the adult aGVHD trial?

DeGroot: I wanted to switch gears a little bit to accelerated approvals. FDA is now working with some more authorities around requiring confirmatory trials to have started before decisions. Any progress on implementing that?

Marks: If you’re going to be submitting for accelerated approval, we’ll need to have reasonable evidence that you’re serious about conducting your clinical trial for confirmation. The exact form of that seriousness is something that we’re still working on.

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Marks: One of the really helpful things in this particular case has to do with the confirmatory trial, which was already fully enrolled. By the time we come into September, that trial will be fully dosed and crossed over, so we’ll actually have additional data coming into fall to know whether we’ve gotten it right or wrong.