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notbrad

07/07/16 3:05 PM

#66319 RE: Pip611 #66318

I'm sorry bro. You haven't been keeping up with the discussions>

Recommended reading for you: Flipper and Senti posts over the past few months.

flipper44

07/07/16 3:29 PM

#66322 RE: Pip611 #66318

One theory that fits (some) both long and short arguments is that they have to wait until 248 events to unblind the results. It fits some short theories because they argue the FDA won't use IA PFS for approval consideration -- only (possibly) final PFS. It fits some long theories because the trial, even if successful earlier, would have to remain blinded so that AA can be pursued in the meantime, and once IA was granted (if it were to be granted) that means we'd be that much further towards the secondary endpoint. There are many other theories of course.

Either way, it appears we have not reached 248 events yet. At least it has not been announced. The further we get down the road without 248 events, the more likely there was exceptional improvement. Particularly without pseudo progressives in the main arms. IMO.

The old saw is that the more interims you pass, the less likely there are good results. That's generally true. In our case we don't know what interim we are at, or if there were interim recommendations, what they were. What seems relatively accurate though is that we have not reached 248 events (or at least it has not been announced yet.) IMO

The latest from clinical trials.gov, NWBO, and Larry Smith is that the trial should end toward Fall, or the end of this year or early next year. That would be remarkable, because there are very few pseudoprogressors left in the main trial to get long PFS for the SOC arm. IMO