Replies to post #4854 on Dendreon Corp fka DNDNQ

[steveporsche]

9902a 36 mo. survival Provenge - 31.6 months, Placebo - 21.2 months. You should now these numbers Crou as you made a boat load on those calls.

As far as the 9901 TTP p-value adjustments, from AC stat briefing docs:

Study D9901 was unblinded in JUN 2002. At that time, the p-value for time to disease progression in the ITT population was P = 0.088 (log-rank test) when comparing the two arms. The p-value changed to P = 0.085 due to a correction by the independent radiology facility reviewing the scans. A complete clinical audit was performed comparing source documentation at the clinical study centers to the clinical database. Based upon this intensive review of the unblinded data, additional corrections and/or adjustments to the data were warranted, and the p-value changed to P = 0.061 for time to disease progression. A radiographic error was subsequently discovered by the third party CRO responsible for confirmation of objective disease progression, resulting in a p-value change to P = 0.052 for time to disease progression.

[walldiver]

-9902A three-year survival: 32% Provenge arm, 21% control arm

-9902A median survival: 19.0 months Provenge arm, 15.7 months control arm

-Glad you don't think approval is a slam dunk, even with stat sig 9902B results on the interim