KZA 0.00% 8.0¢ kazia therapeutics limited

Ann: Paxalisib receives Fast Track Designation from US FDA, page-30

  1. 114 Posts.
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    I fully agree that reporting of results cannot be influenced by Kazia management.
    But I am afraid that potential improvement in OS has little to do with the observed delay in reporting of results, at least the primary results.

    The primary objectives of all ongoing studies are time-driven, not event-driven. They all have clear, pre-determined timelines for the assessments of the primary endpoints.
    Arguably, if everyone died much sooner than the end of the follow-up period then a study would be over sooner.
    But what we are experiencing is a push-back of reporting timelines or a significant delay vs. trial estimates.
    In my view that can only happen when patient recruitment is slower than anticipated - as the follow-up timeframe is measured from Last Patient In.


 
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