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Oncothyreon Inc Message Board

  • rsncan11 rsncan11 May 6, 2011 8:47 PM Flag

    Interesting last question in conf call

    Perhaps you have heard the Stimuvax statistical setup of the trial before, but I hadn't. Interesting assumptions of 20 month survival advantage for control, 90% powered, capable of 6 month survival advantage.....any comments from the pros on how we can reverse engineer that info better.

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    • Holder,

      There was no phase I in breast with stimuvax but its sister compound theratope had all three phases, I,II and III. There was activity with theratope and some promise in exactly the same subset Merck was recruiting for STRIDE.

      The only case of encephalitis which may have been linked to stimuvax was in the Multiple Myeloma trial.

      There were NO other cases in any trials with thousands of enrollees and although there is no way of proving it, most researchers do not believe stimuvax was involved.

    • Hi nononsense,

      Thank you very much for that info.

      To clarify, was it a jump from a completed phase I safety in breast directly to phase III?

      Or was the FDA allowing them to skip both phase I and phase II in breast?

      Was the encephalitis case in the breast or lung?

      TIA

    • Dear rsncan11,

      I do not think that an examination of the width of the gate at this stage would advance the argument.

      What is apparent that with the safety trial a median survival advantage of four years plus was shown.

      This information was not considered by those that designed the START trial.

      The first look was compromised by the events of the time Stop and consequent statistical revision and for whatever reason a go on was declared.

      The real problem for the Safety Committee is not that Stimuvax will fail but that it will succeed at a much better rate than previously contemplated.

      The population being sampled is comprised of those whose disease had been halted and consequently all will survive longer.

      The second look should show a better than predicted result but we have to wait till November or later if they are not falling from the twig quickly enough.

      All my own opinion and do your own due diligence.

      Regards

      William

      • 1 Reply to walshingham07
      • Sir William,

        I will not pretend to understand all the statistical information. I am well versed in technical stats, but not in biomedical stats.

        My question to the experts: If the trial is said to be able to statistically see a 6 months survival advantage, then could we not start to get confident in the trial when the total population starts to see 24 months survival (20 month + 6 month advantage for stimuvax and 20 months for the control = weighted avg of 24 months). I realize that potentially the trial may still have to go to the end if it was a close call, but I am thinking somewhere around 24 months plus 4 more months for data review (from the point when we have enough enrolled for the 2nd event look) and we haven't heard anything, then we should start doubling down. I know ramp up on enrollment might make the math not as straight forward.

 
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