Walldiver:
1. In addition to acceptance of the Provenge BLA as apparently complete, the FDA Priority Review decision is interesting for a couple of other reasons: (1)CBER requires a pre BLA inspection of a proposed production facility. While this might be no big deal for a J&J, Abbott and the like who manufacture drugs in existing facilities, it is a big deal for a new autologous biologic since the basic product characterization issue has sunk previous therapeutic vaccines, and the potency, purity and stability issues that DNDN's quality assurance protocols must have addressed may have been unique and the first of their kind to be inspected by the FDA.I'm assuming, of coutse, that no show stoppers were present.
2. The second issue concerns whether any FDA Provenge approval was going to be held up until the 9902b clinical trial was fully enrolled, and would become a Phase 4 post marketing approval trial. The 9902b figures presented as part of Dr. Provost's 2/9/06 presentation to the CBER CTGT Advisory Committee suggested that 9902b enrollment may have only been at the 20% or lower level at that point. IMO, completion of 9902b enrollment, described initially as being expanded for compassionate purposes, has declined in importance. If the March Advisory Committee is largely selected by CBER, as I believe that it will be, a highly likely and strong recommendation for FDA approval, FDA approval in May may be virtually assured. Recent comments by Dr. Daniel Petrylak on studying optimal sequencing of Provenge and Taxotere suggests that he may believe that Provenge booster dosing and less than full courses of Taxotere may provide equal or better results than the one year increases in median survival that Taxotere following Provenge achieved in the 9901/9902a trials. The FDA and DNDN likely realize this, as will an Advisory Committee, which in many ways, suggests that different clinical protocols could rapidly obsolete the 9902b trial protocol and further improve upon 9901/9902a efficacy. JMHO.
Good luck to all DNDN longs.
