Dendreon Corp fka DNDNQ

[p3analyze]

"I’m astonished that you think it may."

Yes, I thought you would be. I am going back to my favorite Gliadel FDA approval example. They filed based on a significant survival benefit with p-value less than 0.05 via a stratified log-rank test. However, the SPA'd analysis plan said an unstratified log-rank test should be used, and unfortunately that test yielded a p-value of 0.08. FDA rejected the NDA, but six months later, with more deaths occurred, the unstratified log-rank p-value became smaller than 0.05.

The sponsor refiled, and the drug was approved by FDA.

Of course, this would only happen that FDA really were thinking like doctors but not statisticians. Time has changed, and FDA has been pazdurized. Despite this, I still think provenge would have a chance in front of an ODAC if that scenario of yours played out.