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YM BioSciences, Inc. Ordinary S Message Board

  • bio_boffin bio_boffin Feb 4, 2006 10:10 AM Flag

    First Interim Analysis

    The Standard and Poor's report says that the first interim analysis is expected to occur at mid-year 2006.

    Since YMI's fiscal year starts at June, this means that 192 events are expected to occur at the end of December 06/ early Jan. 06 i.e., the interim analysis has already come and gone.

    This is precisely what my modelling of the trial data and the interim looks predicted. The chances of the required 50% improvement in overall survival are very low at the first interim analysis since the literature on tesmilefene indicates that its effect at the early stages of treatment are limited, but that its impact increases with time.

    According to my analysis, which is based on the results of the first trial and the recruitment timing of the second trial, the interim look at 280 events (predicted in April) has just over a 50% chance of success (i.e. the model shows just over a 50% improvement in OS), and the interim look at 320 event (predicted in June) has an even better chance of success - but it is still not a sure thing by any means.

    The complicating factor here is that my analysis is based on the results of the first trial. However, if the overall survival is better for the total population (either because the tesmilifene group, or the standard of care group, or both have better OS than the first trial) then the times to interim analsis will be shortened, and of course the converse is also true.

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    • "The complicating factor here is that my analysis is based on the results of the first trial"

      Obviously not.

      The group of patients in the current trial were selected from a subset of the 1st trial...where a 143% OS benefit was found. So, this trial uses a historical 143% benefit to chase a 50% OS benefit....something I would calculate as being QUITE probable to succeed.

      You are sounding more and more like a basher.
      Or, at best, extremely cursory in your "analysis."

    • "The chances of the required 50% improvement in overall survival are very low at the first interim analysis since the literature on tesmilefene indicates that its effect at the early stages of treatment are limited, but that its impact increases with time."


      Huh? What does the early stage effect of the treatment have to do with the final OS benefit? Doesn't OS necessarily include all stages of the treatment?

    • 'However, if the overall survival is better for the total population (either because the tesmilifene group, or the standard of care group, or both have better OS than the first trial) then the times to interim analsis will be shortened, and of course the converse is also true.'

      You need to do some better research...the subgroup used in this trial achieved 143% OS in the TES arm in the last trial; however, they only need to achieve 50% this time to stop the trial at the first interim.

    • #1 Why would YMI, and other analysts, keep saying "PLANNED FOR MID-2006" if mid-2006 had already passed? (mid FY 2006) this is the clearest evidence that it is a CY, not a FY.

      #2 S&P reports became obsolete 15 years ago, as far as usefulness, imo.

      #3 it looks like you did not use 143% OS in your calculations, which was the result in the last trial (NOT 50%)

    • S&P clearly refers to 2006 calendar year and YMI fiscal year.

      Otherwise I have no idea how you made your analysis. Randychub has given some rough but useful
      analysis on the board. I am sorry I do not recall
      message nubmer and I am lazy to look it up.

      Yahoo should have reasonable search function on this board but unfortunately they do not have it.