Replies to post #4454 on Dendreon Corp fka DNDNQ

[poorgradstudent]

ok thanks...

>Do you think that a few FDA docs who knew about the poor preapproval inspection outcome also noted that DNDN's CEO sold $2.7 million of DNDN shares without telling his shareholders about that problem? <

It certainly wouldn't surprise me if some of the FDA insiders have enough stories to fill quite a few volumes of books. So yeah, one of the guys on the FDA manufacturing side may have curiously checked out DNDN and saw the sales and tsked... problem for the FDA people is that I would believe the punishment for their indiscretions, if they were to talk, would be much greater than the punishment that a biotech ceo... er... BOD would dish out to the ceo. Maybe they angled for the approvable to punish gold's bad behaviour? Unlikely, but a funny thought.

Around the time of gold's sale, I did speculate that something strange was afoot. Gold was the only day-to-day insider that sold (i think most bod members are arm's length and not greatly involved), and I thought it fishy that everyone else was passing up a huge payday. Either those other officers were really, really bad at selling for a 2 or 300 percent profit, or they genuinely believed it inappropriate to sell given the confidential information they possessed. If that is the case, it would indirectly reveal gold's motive in not disclosing the problem(s) that they encountered.

[rancherho]

BTW, dwightd pointed out in msg 140582 on the IV MB that Gold stated at the ASM on June 6 that the Form 483 issues would be cleared up by the end of the year.So much for their rapid resolution and the fact that they would not be material wrt a May 15 PDUFA date. No wonder that the contents of the CRL and Form 483 have become such a "proprietary" deep dark secret.

[Biowatch]

>The DNDN non-disclosure problem is compounded by the fact that in the 10K issued in March and signed by every Director escept Susan Bayh, they not only fail to list the preapproval inspection and its outcome in the Section describing Ongoing Regulatory Activity, but describe the requirement for the inspection as something that hadn't occurred yet. Both the CEO and the CFO certified the 10K per Sarbanes Oxley as being materially accurate.<

Out of curiosity, so you know why Susan Bayh did not sign it? Was this typical for her or unusual? (Or was she just not there at the time.)

Thanks in advance.

I also thought Gold's stock sale seemed strange, given that the advisory panel vote was better than I expected in regards to efficacy.

I don't know what the manufacturing issues are, but DNDN's approach is more labor intensive than most, and will require meticulous cleanliness, record keeping, and tracking to make sure that each patient receives their own cells back free of contamination.