Replies to post #44900 on Biotech Values

[DewDiligence]

Scher’s best argument (IMO) is that the panel vote was contrary to what ODAC has done and potentially sets up a bifurcated approval threshold.

One of Scher’s weaker arguments is that approving Provenge could cause other trials in HRPC to use Provenge in the control arm. This is a weak argument because, if it turns out that Provenge is no better than a placebo, the trials in question will effectively be placebo-controlled.

[gofishmarko]

>> The absence of the intended immune response in the Provenge group suggests that, if anything, the placebo group has a chance to benefit from the procedure rather than being disadvantaged. <<

This is something I'm not quite clear on. Is the placebo infusion treated identically to Provenge , except for the addition of fusion antigen , or is it simply stored and reinfused ?

The APC-enrichment steps that are done prior to antigen incubation could be the MOA of Provenge , for all they know , so if the placebo prep does not get this treatment that is indeed a serious flaw in the trial design.

Anybody know , offhand ?