<mitch does not want to fight. Hes content to wait. He could have others fight the battle for him but with no big personal financial stake, he has no pressure to do so.>
hard to disagree with this observation, though i'm not sure his apparent refusal to partner back in 2004 supports that he wants to be a "member of the establishment" (or at least that he knows how to make friends & influence key people)
I suspect Bogdan has been advising DNDN management re: the FDA approval process for the past couple of years and the decision to file the BLA on 9901/9902A was based in part on the presumed fact that CBER (& not CDER) would be responsible for the review/recommendation if not approval decision.
I also don't doubt that the signals sent by CBER to DNDN re: 9901/9902A were likely very encouraging and assuming that to be the case, it seems reasonable that DNDN's strategy would be to try to not make any unecessary waves that could be perceived as antogonistic to anyone at the FDA, particularly CDER. in other words, leave the BLA in the supposedly capable hands of CBER, trusting them to help get it approved.
i think that is the most plausible explanation for DNDN's seeming hands-off approach throughout this process and after the panel meeting and i can't say that it was necessarily unreasonable. with the change to the efficacy question & re-vote, etc., i suspect Gold (like many longs) thought this was a done deal and that their strategy had worked. Consequently, DNDN decided it would wait to raise cash until after the formal FDA approval anouncement and meanwhile Gold would take the opportunity to cash in some shares at a price that would be seen to be very "conservative" after approval and likely well below any future financing/partnering price...
the fact that CBER didn't come through as expected obviously caught the company completely off-guard, though i wonder if management was listening to what Bogdan was saying in word or in deed after the panel meeting (when he sold the majority of his shares shortly afterwards).
the CR letter sent management into full blown crisis mode and i suspect that Gold was purposefully vague on the May 10th cc about what additional efficacy data the FDA was looking for, probably because he was still in disbelief and denial and was hoping that management could somehow address any FDA concerns via another alternative other than to have to wait for the slow enrolling 9902B interim results sometime in 2008.
I suspect that the informal discussions the company has had with the FDA since May 9th re: additional data has exhausted all alternatives and confirmed (as evidenced by yesterday's pr) that 9902B is indeed required for approval, which essentially also eliminated the prospect for any appeal, at least in management's eyes.
that said, i don't see how DNDN formally appealing the decision could possibly further erode or endanger any so-called relationship they have with the FDA - CBER & von Eschenbach have proven themselves unreliable partners so who cares what they think of an appeal and CDER's ongoing opposition to Provenge won't be lessened by DNDN remaining silent.
in fact, a pr stating the company plans to formally appeal the FDA decision imo, would at least offer the prospect of much needed greater public scrutiny of the FDA's decision & more generally the propriety of same, while also supporting the efforts of the patient advocacy groups...they could make the case that changes to the COI guidelines implemented since the Mar 29th panel would have prevented Scher from casting a vote, (while drawing attention to his questionable conflicts). greater scrutiny likely resulting from an appeal could also draw attention to the public leaking of not one but two apparent confidential letters to the FDA by panel members to the Cancer Letter, the naked shorting & unusual trading in the stock & options, the apparent public leak of the FDA's CR decision more than a week before May 9th where a new york based financial type apparently had foreknowledge, etc.)
I think such a provacative pr would certainly get the market's attention...including the 40M reported shorts, whose only fear i suspect, is greater scrutiny...getting them to cover their shares would provide the basis for a much better financing while supporting existing long-suffering shareholders...and i don't see how, with the added public scrutiny, it could hurt their chances for approval even if the appeal fails & they wait for 9902B...
I think management has "calculated" that formally appealing the decision would not be in their own benefit or best interests. understandable to a certain degree perhaps, but imo, it leaves PC patients & DNDN shareholders in the cold to fend for themselves.
I wonder what Bogdan's opinion is about an appeal & if it is any different than management's?
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