Dendreon Runs to Daylight

Obviously, changing the key question in mid-vote is controversial and suggests to some that the FDA might want to look askance at the panel's recommendation and turn down Provenge.

But it was Witten -- the FDA reviewer ultimately responsible for making the Provenge approval decision -- who allowed the change. I think that says a lot about the FDA's thinking on Provenge, and it points to a May 15 approval.

There also was a lot of discussion about the ongoing Provenge phase III trial, which is enrolling 500 prostate cancer patients and will likely be the final arbiter on whether or not the vaccine can extend survival. Panel members and the FDA are clearly eager to get that information, but it's not likely to be ready until 2010.

The bear case against Provenge has been -- and continues to be -- that the FDA will need to see survival data from this phase III study before approving Provenge. But three years is a long time to wait, especially for a relatively nontoxic vaccine like Provenge that has some compelling efficacy data already in hand, as well as significant public support (as was demonstrated Thursday).

My best guess is that the FDA will grant approval to Provenge next month, with some promise or guarantee that the ongoing phase III study is completed and survival data collected as soon as possible.