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GTX Inc. Message Board

  • yellow.bluff yellow.bluff Jul 25, 2013 12:27 PM Flag

    P2b and P3s never more scrutinized and have never looked better....

    Here is what we know

    First, AFs hit piece on the P2b is filled with blatant errors. His mean baseline assumptions are stair climb power are horribly wrong but incredibly they are also the crux of his whole argument. Mean baseline stairclimb power was essentially equal across all three arms of the trial. No wonder he has gone radio silent. There could be a repercussion here.
    Second, we know the P3 patient drop out rate is lower than the P2b, meaning that eventhough the P3 trials were already powered well, we will even more patients for data readout, helping drive stat sig of the results.
    Recent poster data shows a stat sig correlation between increase in lean body mass and increased stair climb power - again this should help getting to postive results.
    This is a responder analysis - if placebo patients must not lose weight AND be able to increase their stair climb power. If they fail on one of these, they are a non responder. This should help results for enobosarm as it seems hard that a cancer patient just starting chemo and getting placebo will not lose lean body mass and get stronger on the stairs after three months.
    Net net, FDA likes this drug, giving it fast track status and providing an SPA on the trial.

    yb

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