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flipper44

02/25/16 3:09 PM

#55118 RE: Doc logic #55117

The immunology data were of considerable importance. Again, I think the one significant challenge for the phase II Direct trial is to determine real progression from false progression. If they can resolve this issue in the trial design, then at least patients without progression will be able to continue with treatment, which is likely the most important factor in therapeutic efficacy. (In the DCVax-L trial even patients that progress while on treatment may continue therapy with DCVax-L....I think that will prove to be a fortunate thing -- despite some degree of crossover confoundment it undoubtedly causes.)

Pyrr's points regarding the phase I potency and patient status modifications midstream can only be (hopefully) made moot in another trial with a good efficacy design.