Replies to post #4175 on Dendreon Corp fka DNDNQ

[nmstav]

Re unresolved 483, why did FDA act on PDUFA deadlines


What's most confusing to me, however, is the role of the FDA wrt going forwards with the PDUFA decision when there was, apparently, an unresolved 483 on the table.

Has the FDA ever moved forward with a PDUFA decision knowing there are unresolved 483 issues? And most confusing to me also....

[croumagnon]

"this seems a very non-trivial suit"

The 483 issue and the fact that DNDN management knew about it before the insider sales is a non-trivial suit for sure. I also suspect that DNDN management were aware of the faux pas they did by selling shares and that is why they were very defensive at the CC following the "approvable letter" to emphasize the fact that the CMC issues raised by the FDA were trivial and easily addressable...