Can anyone answer this: I know the interim look for Provenge is triggered by a certain number of death events and we know that Gold has said the number is more than were in the pooled results of 9901 and 9902a. The primary endpoint is overall survival. I have also heard that a Cox regression analysis is prespecified. My question is--is the interim look also to be subjected to the Cox analysis and is the Cox analysis to be that which maximized the p value in 9901? Which p-value will the FDA be looking at, the raw p-value or the Cox adjusted p-value to determine if the interim provides sufficient support for Provenge's efficacy to justify approval??
If the pooled results were stat sig at p=.011 and the interim will have even more death events and be subjected to a prespecified Cox analysis, why is everyone so skeptical that the interim will be sufficient for approval?
Lastly, I have to say as an attorney that I have little hope that the Care to live suit will have any luck. My experiences suggest that federal judges bend over backward to protect federal agencies and will even be hostile to the strident (although I believe accurate) allegations of the complaint. That said, the dismissal of the suit could prove to be a buying opportunity for those who believe Provenge works--price might dip as those hopeful of a good outcome to the suit bail out. Anyone know when or if a hearing is scheduled on the motion to dismiss??
