re CEGE: A pivotal superiority trial such as the VITAL-1 trial pitting GVAX vs Taxotere means that GVAX needs to improve survival over the Taxotere arm with statistical significance. The asymptomatic patients in Taxotere's pivotal trial that got it approved had a median survival of 23.0 months. That figure will be extremely difficult, if not impossible, for GVAX to beat. If CEGE had been able to negotiate a noninferiority trial into the SPA instead, then roughly all GVAX would need to do is come within a certain percentage of Taxotere's median survival...perhaps 2%, or 5%, or even 10%. It appears that the FDA didn't let CEGE get a noninferiority design for this trial. Either that, or CEGE mgmt isn't very smart.
