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Dendreon Corp. Message Board

  • kinaseman kinaseman Mar 11, 2012 4:44 PM Flag

    Re: zytiga would never have reached stat sig even against placebo...

    That's why they are doing away with the placebo arm... Now there is nothing to compare to... FDA will never allow label expansion... Placebo and zytiga curves were converging when halted... Scher knew it would not reach stat sig by time median death was reached... The trial would have doomed the molecule to the dust bin... Unbelievable... See you on the otherwise of the gap, $35.84... FU PCF, Milken and Scher...

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    • Can the the FDA approve Zytiga based on the PFS stats sig alone? And, if they do, will docs go along with prescribing it?

      • 1 Reply to jptrs123
      • The gold standard finally adopted by the FDA is Overall Survival... PFS is only a surrogate for OS... The fact that JNJ agreed to halt the trial before stat sig reached implies it will never be reached and the KM curve was deteriorating... Any clinical physician that gets behind this move and purports that this is good should be investigated because from a clinical outcome perspective, the likelihood of improving on the the significance is all but gone with he crossover... The best they could do now is have to do another study... If the clinical oncologists back this they should be made to answer why... No way zytiga ever reaches stat sig and the hedgies that are paying for media bashing are quite honestly are trying to put a positive spin on negative data... When KM curves start to converge, you're going to get high p values and negative bias... That is the reason this wad stopped... It has nothing to do with helping patients... The truth will prevail... Scripts fir Q1 will provide blowout numbers... See you on the otherwise of the gap, $35.84... FU Milken, Cramer, Morgan Joseph and the rest of the Milen-Boesky cronies...

 
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