Dendreon Corp fka DNDNQ

[iwfal]

Those are valid points raised by Toos...the question remains, though, did DNDN respond to the FDA prior to PDUFA with the necessary corrections to the issues outlined in the 483?

The point is - how much does it matter if they were minor points that would have gotten signed off in less than 3 or 4 months?

I believe that you would have considered an approvable (or approval with a lien? - not clear to me how they would have worded it) with the only lien being something worked off within 90 days to have been a home run. I certainly would have.

I understood the 'might as well give them an approvable if they have a manufacturing issue' argument but I think this is a very weak argument if the 483 is something that could be worked off in 60-90 days.