Replies to post #2251 on Dendreon Corp fka DNDNQ

[steveporsche]

I don't think the cox analysis on 9902a will be of benefit to the BLA in the FDA's eyes. If the log rank is not significant, I don't think they pay much attention to the cox analysis (see FDA quote below). I really hope they consider the 3-year survival numbers as supportive enough.

"The sponsor used the Cox multiple regression model to adjust for potential imbalances within the two treatment arms. A reference is given to Akazawa et al. (6), highlighting the regression model’s ability to adjust for the imbalance of prognostic factors between two treatment groups. Such a strategy is not intended to be used as a substitute when the primary analysis has failed according to the log-rank test."

This is from the ALTH clinical review in the briefing documents.

See right below Table 24:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037B1_04_B-FDA-Clinical%20Review-RSR13.htm