Replies to post #4172 on Dendreon Corp fka DNDNQ

[akasidney86]

The questions raised by the 483 issue are many:
First, whether serious (major objections are being raised by the FDA) or simple (easy manufac. adjustments can be made to correct the problem), the fact is that the applicant MUST respond diligently, and the question then is did DNDN do that?
Second, the insider sales and their relationship to the 483. Very serious, IMO, if it can be shown that they knew about the 483 issue and were either ignorant of it's 'cease and desist' nature, or worse, ignored it. Either way it's probably fatal (there is a 'reasonable man's conclusion' test wrt culpability and responsibility) for those inside traders (Gold, Bogdan and Kunath).
Third, and quite conceivably beyond the pale of rational conjecture, the possible relationship of HBK and their massive investment to Susman and the 483 suit. IMO worth considering none-the-less.
Forth, the impact, if any, this suit may have on the placing of the convertible.

All up, this seems a very non-trivial suit. 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.