1. The real danger to DNDN may be the recent complete enrollment of CEGE's Vital1 600 patient trial (which began enrollment a year after 9902b) and their CEO's projection that its interim look will occur in 1H08.CEGE clains that the Ph3 GVAX dosing is at the highest dose level given in its Ph2 trials and that median survival at that dose was 35 months. This GVAX dosing without Taxotere equates to the median survival that Dr. Petrylak reported for the 51 ITT patients in 9901 and 9902a that took Taxotere after Provenge and will be compared to a Taxotere control arm where Taxotere had a median survival of 23 months in the assymptomatic subgroup in its clinical trials. CEGE's Vital 2 trial which measures GVAX + Taxotere against Taxotere alone is expected to complete enrollment by the end of the year.CEGE has not indicated whether it will be using isome of its alpha on the interim look and whether its interim look is successful could be the basis of a BLA.
2. IMO, Gold and his rubber stamp BOD are blazing a new trail in non disclosure to shareholders and other Provenge supporters by not only not disclosing the February 12 preapproval inspection and the resultant Form 483, suggesting in the March 14 10K that it hadn't occurred yet, Gold selling shares with 2 other directors, and refusing to release with possible redactions, the Form 483 and the Complete Response Letter. At this point why should anyone believe anything Gold has to say? While I find it hard to understand the basis for the efficacy lawsuits from what has been publicly disclosed, that is no assurance that the CRL did not contain more specific information to explain the FDA decision. I believe that Walkenizer pointed out that Waksal mininimized the FDA reasons for the FDA issuing its Refusal to File letter for the original Erbitux filing, which were then spelled out when the letter was leaked to The Cancer Letter. It's a lot easier to spin an FDA action ("minor CMC issues") when you omit what the FDA actually wrote.
3. The recent Clinical Cancer Research article by NCI authors pointed out that there is evidence to suggest that possibly every prostate cancer vaccine will benefit from post immunotherapy Taxotere. According to Dr. Petrylak. the 51 of 147 patients in the ITT 9901 and 9902a (34.7%) who received Taxotere after Provenge had a median survival of 35 months, which logically means that a good portion of the increase in median survival would be due to the combination P+T impact as would be 36 month survival (roughly 47% survival at 36 months for T+P vs 26% for P alone.) BTW, for all conspiracy COI buffs, Drs. Higano, Small and Petrylak are all involved in CEGE's GVAX prostate cancer trials.
4. IMO, the FDA would have been far more likely to back its Advisory Committee and give conditional approval to Provenge were it not for the CMC issues, which I believe would have pushed even that approval into 2008. Combine that delay with the beneficial, but confounding effects of Taxotere and the larger Vital 1 trial and the FDA might have decided that an interim survival look at both immunotherapies during the same year with little impact on faster availability to PC patients due to DNDN's CMC issues might be a better way of getting the best immunotherapy to PC patients quickly. Since the final decision was made behind closed doors, there is no way of knowing exactly why the FDA did not back their Advisory Committee unless some suggestion of that thinking was in the CRL. Pazdur may have played a big role, but he is not in the CBER chain of command / recommendations leading up to vE.
5. Both CEGE and DNDN and better biotech disclosure would benefit if both companies would tell the investing public what alpha allocation they intend to use in looking at interim survival data in 2008. JMHO.
