Dendreon Corp fka DNDNQ

[walldiver]

So let's say hypothetically that DNDN completed a detailed response to the FDA mfg inspectors for everything the inspectors detailed in the Form 483...let's say DNDN did this in early May 2007. The question then would be if anything in that Form 483 requires a reinspection of the NJ plant by FDA mfg inspectors. If so, then the FDA needs time to look over DNDN's responses to Form 483, and then schedule a reinspection. Let's say that FDA finishes looking over the company's responses by June 1st. If so, then would the new PDUFA date be 12/1/07? FDA could reinspect in 9/07 or 10/07, in order to allow some time for the back and forth discussions between the DNDN mfg team and the FDA mfg inspectors.

But as of 12/07 we would be getting closer to the 9902B interim unblinding, which will probably take place somewhere between 160-200 events. Maybe the agency was thinking after the positive advisory panel vote that since it might be another six to eight months after the 5/15/07 PDUFA date for DNDN to satisfy the mfg inspectors, then why not wait just a few more months for the 9902B interim survival data to be unblinded?