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ONYX Pharmaceuticals, Inc. Message Board

big_texis 6 posts  |  Last Activity: Feb 4, 2015 7:21 PM Member since: Feb 11, 2003
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  • As you all probably know, the FDA will analyze these data from scratch on their own. Like every other study they have ever evaluated, they will place the t=0 arrow at the time the drug was started, not at a completely arbitrary time point that happens to represent a inflection point that makes the sponsor look good. Move the arrow the graph in the street update to week 24 (the true t=0 for the placebo arm) instead of week 36 and you have a drug with no benefit. "Time before (or after) detectable" is completely arbitrary depending on how much you claim is detectable... picomoles, nanomoles, micromoles

  • is a dangerous drug. The only obvious thing from the phase II data is that there is an immediate decline in function after 24 weeks exactly timed with the start of eteplirsen in the delayed rx arm. Take off those ridiculous rose-shaded glasses and look at the data objectively for ONE second and you will save yourself a bundle of cash.

  • Reply to

    anyone, FDA included, can only conclude that this

    by big_texis Jan 20, 2015 12:40 PM
    big_texis big_texis Jan 21, 2015 12:49 AM Flag

    Interesting study of human nature. Even with data as plain as day showing deterioration starting at 24 weeks at the exact time the delayed arm begins their treatment, a few losers will chose to ignore the obvious and cling to an outlandish hope that this drug is not harmful. Even though clearly it is.

  • Reply to

    problem will be the FDA analysis

    by big_texis Jan 12, 2015 1:06 PM
    big_texis big_texis Jan 12, 2015 1:46 PM Flag

    If the study had been well-designed with a 48 week placebo cross-over, then it may have shown the differences to be real, but hey that's why you do phase II so you can get it right in phase III. As it is, there is no difference between placebo and intervention during the only 24 weeks for which the FDA will have any interest. They may get another chance to generate some approvable data, but you need convincing data for early approval. These are not at all convincing.

  • Reply to

    anyone, FDA included, can only conclude that this

    by big_texis Jan 20, 2015 12:40 PM
    big_texis big_texis Jan 20, 2015 4:36 PM Flag

    What a scam! The sponsor conveniently ignores the most striking feature of the data: patients immediately deteriorate after starting the drug after a very clean 24 wk pretreatment interval. Sorry, but the FDA will notice this.

  • these small numbers continuing 10 weeks after stopping therapy (26 wk rx) is impressive. But if only at 36 wks and not 27 then got to wonder why. Of course, we dont' know if 27 wk data were unimpressive as assumed or not. Could have been even more impressive at 36 wks if continued rx for full interval. NIH.gov does not even mention 36 weeks as secondary outcome - strange. And no one expected a drug so far removed from an "unmet need" would gain approval on phase 2 alone. That's why you do phase 2 - to optimize your selection of endpoints. Were they hard at work mining data or is this legit?

ONXX
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