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pcrutch

03/06/12 11:44 PM

#138339 RE: jbog #138338

Did you catch what data they expect to have at ASCO for PX-866?
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BTH

03/06/12 11:56 PM

#138342 RE: jbog #138338

I did catch that. IMO, the halt for the death really screwed up the events and timing of this trial, making all assumptions in stat analysis entirely irrelevant (if stat analysis wasnt already).

Too many variables to map out anything, too many unknowns.

I still think this has a very good shot at showing statistical significance in the final analysis, albeit, along the lines of what Dew said -----not, a knock the cover off the ball type of showing.

As I asked someone else, is it possible that you could have had a 6 month OS advantage at the 2IA, and still not have reach an SPA endpoint because the p - and HR was too high of a hurdle?
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iwfal

03/07/12 12:03 AM

#138343 RE: jbog #138338

ONTY

Because of the clinical hold they actually dropped 156 patients that were included in the 1st IA and they were simply replaced with 156 newer patients that were enrolled after the hold. In essence, the 2nd look population wasn't really as old as we originally thought.



FYI this has been well known for quite a while (although there was a nuance of it that I mis-modeled recently - having to do with when they enrolled)