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Doktornolittle

02/22/16 1:22 PM

#54644 RE: flipper44 #54640

But is there a difference, in terms of alpha spend, between a 1st interim look where only futility can be reported/(stop-recommeded) by the DMC, and a 1st interim look where the DMC is also allowed to come back with some other statement related to efficacy... such as, "go for it" with it being, for example, some form of early or accelerated approval for the entire patient population or some subgroup(s)?
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Evaluate

02/22/16 2:53 PM

#54654 RE: flipper44 #54640

In your opinion, what is the likelihood that we might currently be approximately at the 2nd interim, and that NWBO decided not to make any public statements when we passed the 1st interim?
And could the current screening hold be related to 2nd interim?
And would a possible AA be more likely at 2nd interim than at 1st interim?
(Of course the PFS events & OS events continue to occur for the 300 or more patients enrolled, even as the screening halt continues to be in effect).