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Post# of 253269
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Re: jellybean post# 42716

Monday, 03/05/2007 5:28:07 PM

Monday, March 05, 2007 5:28:07 PM

Post# of 253269
The overall survival data for NOVC's trial you're referring to was extrapolated into the future at the time of FDA consultations since it was not yet mature.

NOVC updated the trial data recently at the ASCO Prostate Symposium, and did not release median survival numbers in the PR, nor did they release log rank p values. Overall survival for Asentar in the 250-pt trial thus seems not to have been statistically significant measured by log rank, only by Cox regression. The p value measured via Cox was between 0.03 and 0.04. I don't know if Cox regression was prespecified in the SAP for the Asentar Phase II. However, the Asentar 250-pt trial population can be compared fairly accurately to Provenge's 225-pt 9901+9902A population. NOVC's survival p value of 0.03-0.04 measured by Cox doesn't compare well to DNDN's 0.00006 measured by the same analysis.
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