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Sunday, November 17, 2019 9:12:49 AM
1) they’ve not given any time, as far as i am concerned that is definite or certain, because they can’t. Guestinates are guestimates.
2) what you are suggesting from that reference is some new thing happening, and that is absolutely NOT how i read it. The SAB is there for them every day, any day they need to interface with any of the experts on it. It’s not some formalized process. There is no such thing.
3) of course the SAB has always been a part if likely all of their key regulatory deliberations and analyzing how best to get the treatment approved, and they likely all email each other whenever reasonable to do so. I sumply di not think that reference in the quarterly is what you’ve suggested, something new, nor is it a bug deal in my view.
4) this is the most important time of the trial going forward. Decisions made now will have serious and potentially quite determinative consequences. That they’d be careful and consult properly... well, i view that positively, especially given the quality of the people they can turn to via the SAB. Having those experts willing to go to bat for them if anything comes up, would be quite compelling. But if you don’t include them, well, they have no stake in that decision and it’s no skin off their back if the regulators disagree. It’s actually a very important step.
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