1.IMO, if the CEO and two directors hadn't sold shares in April while being aware of the undisclosed problems with DNDN's pre-approval inspection during the week of February 12 and the misleading statement in the March 10K indicating that it had not yet occurred, DNDN would have had little to lose in appealing the FDA decision and/or going to court seeking a show cause order under Federal Administrative law. Those sales may have also been the reason why DNDN did not update its shelf registration by disclosing the February inspection and the likely delay in approval and selling shares in April when the absence of FDA contact and last minute labeling discussions made it increasingly obvious that there would be no approval by May 15. Unlike AIPC patients or DNDN shareholders, DNDN itself would have had clear legal standing to seek redress for the procedural irregularities. Since there is a SPA in place for 9902b anyway, there would have been little to lose timewise. Such action would have supported DNDN's friends in the FDA while making things decidely uncomfortable for its opponents. IMO, a Federal judge would be appalled by the obvious trumping of fair procedural standards by backroom letters and politics in light of the recommendation for FDA conditional approval by a FDA appointed Advisory Panel and the facetious reommendation by Hussein and others that Provenge be made available on a compassionate use basis, but not be paid for it. A cross examination of Pazdur and vE would probably have been Washington theater at its best. The conflict of interest issues of Scher and Hussein raised by so many DNDN shareholders would be of little concern since they were officially waived by the FDA and the two were overwhelmingly outvoted.I think the TTP endpoint miss in 9901 would also be of little concern since it would have been stat significant under the new rules, but the p value of .0046 for 9901's tripling of 36 month survival of the ITT vs. controls, supported by 9902b's doubling would have impressed any judge.The need of AIPC patients for new therapies would probably be conceded.
2. IMO, the outcome would have been an elimination of the CRL requirement for additional efficacy data, but a continued delay in any FDA conditional approval (pending completion of 9902b) until DNDN got its CMC issues under control, which, IMO will probably involve a facility reinspection by the FDA and as much as another 6 to 9 months to clear up. A decision would have eliminated the need for an interim look at 9902b and increased the likelihood of Regular Approval in 2010 when the full alpha could be used on 36 month data.
3. Such outcome, for better or worse, would have had the effect of focusing a major spotlight on the CMC problems and the whole issue of their non disclosure and subsequent insider sales. Under the present circumstances, the PDUFA review clock will not be reset until the interim look at 9902b data so corrective action at the NJ facility is technically no longer material so long as it's finished over the next year or so.Ironic isn't it how circumstances can line up so that the interests of Pazdur and some DNDN insiders once so diametrically opposed are now effectively aligned? All JMHO.
