KZA 0.00% 8.0¢ kazia therapeutics limited

Ann: GBM Agile Update, page-61

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    Yes, I believe we are at the "STOP MAX" spot after the decision rule for stage 1.
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    I also received word back from James confirming that:
    1. The paxalisib arm will not enter stage 2 even at a later date.
    2. Depending upon the eventual data from stage 1, there is still the possibility of FDA approval.
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    Of course, the data must always be "good enough" for FDA approval to occur. Entering stage 2 would seem to hint that FDA approval would be more likely, but personally, I never expected confirmation at this early point in the trial given what we already know from the previous phase 2 trial. In order to "graduate" to stage 2, a drug may very well have to double the OS to make its effect obvious so early on.
 
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