<"The advisory committee is advisory. Period. It is not a judge and jury. It is not the O.J. trial. It is not: "If the glove fits, you must acquit." It is the advice we are looking at, not the vote. We are more interested in the reasons why people are voting.">
so by implication, the FDA understands the motivations as to why members of the advisory committee voted the way they did and that is the determinative factor for the FDA's decision...
as a former DNDN shareholder this sure sounds like Pazdur is responding specifically to the ongoing Dendreon/Provenge/FDA saga rather than general FDA policy.
and his implicit admission that advisory committee member motivations play a key role in FDA decision-making seems rather self-incriminating considering the treatment was unanimously considered safe and a substantial majority of scientific professionals considered it efficacious, aside from the very conflicted Howard Scher et al.
i can only conclude that the real reason/motivation the FDA turned down Provenge can only be determined by following the money...imo, that provided the prime motivation for the FDA's denial/delay.
in some ways, Pazdur's statement above seems to support this, perhaps even intending to taunt Provenge supporters to try to make such a case, believing himself & his conflicted buddies above reproach.
pazdur is so full of it & himself, it is almost as disgusting as von eschenbach's lack of spinal chord...
AI
