Dendreon Corp fka DNDNQ

[rancherho]

ocyanblue:

>>you still run into the issue that the subgroups that took Taxotere were self-selecting << All patients were asymptomatic at randomization. I know that the theory is that only healthier patients choose to take Taxotere, but the TAX327 study also proved that Taxotere was superior to mitoxantrone and prednisone for palliation of pain and QOL. IMO, the difference in results is so dramatic between the Povenge only results and the combination results that it will be reaffirned in 9902b. Petrylak also used the Halabi nomogram to minimize the impact of bias. The long term survival data also suggests that the Provenge 9902b experimental arm will have an easier control group treatment to contend with than the CEGE Vital 1 Taxotere control arm. All just semi-educated guesses, the data will tell.

BTW, in looking at the AC Briefing Material data again, I noted the followingin statisical errata: "Page 6, Section 1.2 Analysis plan, 1st paragraph, line 6: change the text “an O.Brien-Fleming adjusting” to be “the Haybittle-Peto method” according to the corrections the sponsor provided for their original submission." Google then produced this discussion of interim allocation methods: http://mrw.interscience.wiley.com/emrw/9780471462422/wect/article/eoct030/current/html
This states in part: "Both the Haybittle-Peto boundaries and the O'Brien-Fleming boundaries are very conservative at the interim analyses; therefore, using these boundaries, a low chance of very early stopping exists because of a chance dramatic difference in outcomes. The conservatism of the Haybittle-Peto boundaries at the interim analyses came from applying a uniformly stringent criterion, with a nominal P-value of 0.001, at all interim analyses."
If the Haybittle-Peto method is used in 9902b as well, would this reduce your assessment that the interim might be successful?