Tuesday, May 16, 2017 9:31:25 AM
Now focus on what kinds of data we will probably see. My worst case scenario based on all public information available today, including my estimate that 248 PFS events were reached during Nov 2016 ~ Feb 2017, and 233 OS events have at least not been reached in Feb 2017 (of course the later the better):
We missed in the median PFS primary, meaning there might be no separation when 50% PFS events occurred between both arms, but we will definitely see some separation if not very significant separation of PFS after 50% PFS events, and/or when the 248 events were reached;
We will see meaningful OS separation between the two arms: the early vaccine arm (the treatment arm) and the late vaccine arm (the control cross-over arm), much more meaningful OS separation between the treatment arm and the control arm (those patients in control who elected not to cross over) or the historical data.
I don't see any problem for FDA to approve the treatment if the above turns out to be true.
Any other scenarios are more or less much positive than the case above, which will be readily followed by FDA approval.
Now it's time for countdown!
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