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flipper44

02/05/16 5:52 PM

#52863 RE: Stillwell888 #52857

No, DCVax-Direct used much more profound inflammatory adjuvants in the Phase I trial that would leave larger MRI signals then DCVax-L, IMHO.

Again, for what it's worth, I now assume (as suggested by mapman) the main thing they are likely having challenges with is tumor progression (correctly diagnosed) in placebo responding/stabilizing after crossover and then having to determine if it was a pseudo-progression calming versus a DCVax-L treatment response.

If it was a pseudoprogression stabilization/regression, then they originally misdiagnosed (which does not mean they can't change the diagnosis) a progression as a pseudo progression, and not the other way around.

If it was indeed progression stabilized by DCVax-l, then they'd want to know that too -- even if they had to use other endpoints like immune response (which RK showed is in the protocol and can help support the primary endpoint) to help determine this.