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walldiver

11/25/07 12:35 PM

#5099 RE: iwfal #5097

Yes, but I think the Cox regression p value will be better than the log rank p value, even with the equalizing effect of a much larger trial. Both arms should be stratified for Gleason score, Zometa use, and # of bone mets, but not LDH and PSA. I think the latter two factors, along with bone mets, will figure into the Cox exercise. If the trial is well balanced, I think it's plausible that the Cox regression p value could be half that of the log rank p value. From what we know of Provenge, if the final look happens in June 2009, approximately 325 patients will have been enrolled for 40 to 72 months, approx 75 patients for 28 to 39 months, and approx 105 patients for 20 to 27 months. I think that will be long enough, if Provenge does indeed have a clinical benefit, to hit stat sig on the Cox regression primary analysis, even if only 0.025 of the p value is reserved for the final look.