Are there any other data that help or hurt Provenge's chances?
Yes, on both counts. Dendreon has data from a second, smaller clinical trial that show a similar survival benefit over more than three months for Provenge over placebo. But in this study, the result was not statistically significant. In fact, it wasn't even close.
Dendreon did run another analysis to account for imbalances, just like the first study, and when the numbers were crunched the survival benefit was statistically significant. It remains to be seen how the FDA and the advisory panel handles this data.
C'mon Adam, you're usually an opinionated guy, but in this case, you're sitting on the fence. What gives?
What gives is that I just don't know how the advisory panel shakes out. If the presentations and deliberations lean toward conservative data analysis and adherence to strict biostatistical methods, Provenge is going to be in for trouble.
But if the opposite occurs, if experts on the panel look at the drug through the eyes of a prostate cancer patient and worry less about statistical rigor, Provenge could have a good shot.
I understand your neutral stance, but it's been years since the FDA approved a new prostate cancer drug. In fact, the last prostate cancer drug brought before the FDA, Xinlay from Abbott Labs(ABT - Get Report), was rejected. Also, the new FDA commissioner, Andy Von Eschenbach, is a prostate cancer survivor. I just don't see how Provenge could get dinged.
I understand that point of view, but at the end of the day, the FDA will make its decision based on clinical data. Sentimentality has its place, but I'm not sure I'd make a bet on it. And remember, Dendreon is running another clinical trial with Provenge in prostate cancer. This one is big -- 500 patients -- and is designed specifically to answer the survival question. If the FDA or the advisory panel isn't convinced on this go-round, they'll wait to see the results from this ongoing study. Unfortunately, survival data from that trial aren't likely to be ready until late 2008 or 2009.