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Replies to #42580 on Biotech Values
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jellybean

02/28/07 6:00 PM

#42581 RE: jbog #42580

>>>A separate analysis of the satraplatin clinical trial handed out at the prostate cancer meeting this weekend broke down the drug's efficacy into the aforementioned individual components -- and revealed some worrisome details. On a percentage basis, more satraplatin patients "progressed" because of death, compared with patients in the control arm. And the only component listed above where satraplatin performed significantly better than the control arm was in the reduction of symptomatic pain.>>>

Has anyone here seen this separate analysis? What percentage of patients progressed because of death in each of the trial arms? If there was an imbalanced in overall survival against satraplatin, wouldn't the DSMB have stopped the trial? And, finally this seems like subset analysis, and I don't need to say anything more.

Dew -- are you negative on Satraplatin? and how does this fit in with your negativity?
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p3analyze

03/01/07 2:00 AM

#42593 RE: jbog #42580

time to disaease progression or progression free survival

which was the SPA'd endpoint back in 2003? Based on earlier news release, primary endpoint was ttp, secondary are pain and survival. the current news release seemed to have mixed all three together and called it PFS?


A PFS difference of less than 2 weeks, which could be well within windows of assessment errors, with bulk of events based on unverifiable pain progression, with slightly worse OS what's the ground for approval?