Biotech Values

[walldiver]

<<Is DNDN going up for an ODAC review? If so, when?>>

Nobody knows yet, but if they do file on pooled 9901 + 9902A survival data, then most likely they will go up before ODAC. My post about possible hints for DNDN at the FDA sums up my thinking. I believe the main question about filing on the 9901 + 9902A data is whether or not the statisticians will emphasize the missed primary endpoint of progression. When DNDN and the FDA designed these two trials in 1999, the goal was achieving stat sig on pooled progression data. They missed progression, apparently missed the secondary endpoint of pain also, but at the moment it looks like they will hit the survival endpoint with a p value of 0.005 or better. Whether or not this is good enough for the FDA is the big question mark at the moment, and it's the reason there is such a large short position (close to 50% of the float) in the stock.

What works in Provenge's favor is that quality of life is very important for asymptomatic HRPC patients, and a six to seven month cycle of Taxotere plus Prednisone with the accompanying severe side effects discourages a lot of elderly patients. Provenge administration consists of three infusions at Weeks 0, 2, and 4, and the only side effects consist of mostly mild chills and fever lasting for a day, or two days at the most. Provenge nearly doubles Taxotere's median survival benefit and probably increases the three-year survival rate by three to five-fold over Taxotere.