Replies to post #3519 on Dendreon Corp fka DNDNQ

[p3analyze]

FDA sent a complete response letter which is generated when FDA decided not to approve at this time. It may have requested OS data from currently ongoing study 9902b, and DNDN may ask for permission to perform an unplanned interim analysis, or shift the timing of the existing interim analysis in a type A post-action meeting which could occur as soon as 2 weeks from May 10th.

If OS data from 9902b is required, and the analysis of OS is positive, the company needs to resubmit the filing and the filing will be reviewed as a Class 2 resubmission, which has a 6-month review clock. So if FDA and DNDN were to stick to the SPA, and conduct the interim analysis in mid 2008, then the anticipated approval date is 1st half of 2009.

I personally hoping for an earlier than later interim analysis and I wish that FDA would accept a positive trending interim OS in the event of less than statistically significant OS benefit and grant approval upon resubmission.