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....