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Re: Chiugray post# 7127

Wednesday, 03/26/2014 9:05:28 AM

Wednesday, March 26, 2014 9:05:28 AM

Post# of 701686
I think the point you raised is excellent, but I don't think the data would come from crossovers related to the 33. The 33 were likely all treatment arm, as no placebo had been invented back then. Therefore the control arm knew they were not getting the therapy and typically did not enroll or discontinued.

Nonetheless your point is well taken that:

When [] control arm patients crossed over to the treatment arm for DCVAX-L, as is allowed, the PEI observed superior efficacy. That is why the PEI approved DCVAX-L as a stand-alone treatment and ditched the radiation/chemo SOC. --Chiugray



I really can't confirm yet that Germany (the PEI exempted hospitals) can currently use DCVAX-L as a "stand-alone treatment," but it makes sense that the crossover arm, even if it did not include patients from the original 33 cohort, might potentially present compelling evidence to substantiate such a practice. Other evidence might come from compassionate use and Doctor Gorter's alternative clinical data.


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