Iwfal:
1. Generally, I agree that it doesn’t pay to fight city hall. However, there apparently is an FDA white paper that says that in the last ten years, the FDA has accepted and acted on a positive recommendation for approval from an Advisory Committee some 37 of 38 times and the applicant withdrew its NDA in the one case where there was no approval. Under such circumstances, a procedural appeal should almost have been expected by the FDA. While the non approval on CMC issues might have remained until corrected, a Court might have thrown out the need for additional efficacy data since there will be no other AC on that issue, especially if it was thrown in the CRL by the FDA Reviewer since there would be a delay in any case on the CMC issues, as croumagnon speculated.
2. The hullabaloo over on the IV MB about DNDN shareholders suing the FDA when only DNDN clearly had the standing and opportunity to do so, and over the conflicts of interest of Scher and Hussein, who, after all, openly cast two of the four minority votes against Provenge on the efficacy issue seem irrelevant or tangential at best to a reasonable goal of exploring the action behind closed FDA doors where the law specifies that the FDA can only officially take advice from a validly constituted Advisory Committee.
3. >> Ok. Still not an accepted endpoint. Also note that the FDA is steering away from TTP in general - so going in and trying to modify the SPA, which at that point had survival as the primary endpoint with all the alpha, back to TTP, especially a totally new paradigm of TTP, is completely unrealistic.<<
The CRL reportedly asked for additional clinical efficacy data and didn’t specify that it needed to be statistically significant survival data. Since the 9901 TTP data miss as a primary endpoint under the old rules was the reason that the FDA statistician wouldn’t even answer Scher’s question as to the risk of the survival data being a false positive, if statistical significance for increased TTP were reached with new data from a much larger number of enrollees following the same protocol, it seems to me that would be additional efficacy data that would support the AC's decision to consider the survival efficacy data in spite of it not being the primary endpoint in either 9901 or 9902a. Perhaps there was still another undisclosed reason for the CRL and the FDA's request for additional efficacy data (other than Gold's dismissive comment about human nature) that was a reason why Gold elected to place the BLA on the shelf until the interim look at 9902b survival data.
4. BTW, FYI, I was once a large DNDN shareholder, but presently have no investment long or short in DNDN. I am an attorney and a plaintiff in the 483 lawsuit, but I am not an attorney handling this case. I have spent most of my business career in an entirely different field and have not actively practiced law for many years. If there is any recovery, I will receive the same percentage of recovery proportionate to my losses as any other DNDN shareholder damaged during the class period, as the Federal statute is careful to provide. Under 9th Circuit rules, the attorneys handling such cases are limited to 25% of any recovery. Good firms and attorneys don't take cases where there is little hope of recovery. My belief is that there may be a decent amount of recovery in this case, but that will be up to a Federal judge and jury. I am also unaware of any attorney handling any of the 10b-5 class action lawsuits actively posting on this MB or any other, although I would not have any way to confirm that. If a successful lawsuit causes DNDN to change its way of doing business, existing shreholders could benefit more than from the impact of any uninsured damage award that DNDN might incur itself. Whether or not that happens, if directors did breach fiduciary duties to shareholders, they should be held accountable. JMHO.
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