<<Which trial showed Provenge's 3 year survival advantage?>>
Both 9901 and 9902A...9901's metric was stat sig at 0.0046
<<What are Provenge's TTP results? Where were they published?>>
9901 = 0.052 published in JCO July 2006
9902A ~ 0.70 from FDA briefing docs
<<Provenge's effect on PSA doubling time?>>
Delays it, I believe significantly, but PSADT was not the primary endpoint of P-11 trial. Time to threshold PSA velocity was, and I believe Provenge showed a clinical benefit that was not stat sig. Check the archives on the DNDN website, I believe the PR is from Q3 or Q4 2006.
<<Which trial showed the Provenge 300% three year survival advantage?>>
9901, but the survival advantage vs control was only a triple, therefore it was only a 200% advantage (34% alive vs 11% alive)
<<When were the new FDA COI rules put into effect? Link?>>
If you're referring to the rules in the new PDUFA law, the Senate is currently working on it. Then it goes to our Chimp-in-Chief. There have been no other "new" COI rules, despite what some I-V posters believe. The announcement a few months ago wasn't new, they had always been in place.
<<Quotes from VE, Padzur, Scher, Hussain and others regarding delayed immunotherapy response...examples of VE's support of Provenge and other immunotherapies leading up to AC panel.>>
Check the ODAC archives on the FDA website and the 3/29 CTGTAC transcript. Anything Von E said might be at the February conference archives, I believe it was the NIH-NCI immunotherapy meeting.
<<Reasons why Provenge approval would be a slam dunk given the new CBER guidelines released on 5/15>>
Uh, no. No new CBER guidelines on 5/15, they had already been in place, it was just a clarification. In addition, Provenge approval is not a slam dunk, and you know it. We had a 13-4 efficacy vote go in our favor, and it was still turned down. CBER is probably the weakest division politically inside the FDA. Who's to say it won't cave again, even if DNDN files on 9902B interim results with a p value between 0.01 and 0.05? Pressure needs to be applied on the FDA by the advocacy groups prior to the decision, even if the p value is better than 0.01.
AI
