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OncoGenex Pharmaceuticals, Inc. Message Board

  • bagholderzunite bagholderzunite Feb 11, 2014 3:11 PM Flag

    Question for Summer

    Summer: I'm having a tough time getting my head around the proximity between the efficacy interim and the final event count being hit -- these two events appear to be only what, at most, 4 months apart (September for the interim, call it, and January for the final event).

    There's nothing I can do to my model that would make sense of this if the efficacy interim were done at even as high as 80% of events. It just doesn't work.

    What do you make of this?

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • maybe u need smaller hed

    • I dont think this is far off from the expected. I was not expecting an announcement now for the number of events but I was thinking mid May for the data.

      Why do you say 4 months apart? Assuming 3m for the analysis (which is normal), we are about 6m from the interim event and then another 6m from the previous interim event.

      How many events per day does your model tell you?

    • How about a rash of deaths in the control arm.

      • 1 Reply to dilivent
      • Well, Summer did post something about how the deaths would occur in an asymptotic rather than linear fashion, which I think is consistent with dilivent's "rash of deaths" theory. It would probably be best to let Summer speak for herself though, especially since I don't really remember what an asymptote is.

        But as long as we're asking her questions, I have one. If custirsen should fail to achieve statistical significance in SYNERGY, is the FDA likely to require a lower p-value than .05 in the AFFINITY trial? Since AFFINITY involves second-line patients and SYNERGY first-line patients, I'm not sure why the results in one should affect the requirements in another but maybe they would. OGXI has said the FDA has agreed that success in SYNERGY would suffice for approval (because the results in the P2 trial would count as the second trial it usually requires) but it's never said that about AFFINITY. Would it matter whether SYNERGY showed a trend in custirsen's favor?

 
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