Galzus Research,
Two key points that your claim about early separation ignores. The first is the methylated patient response to DCVax-L which was significant even when compared to historical or well matched contemporary trials as a whole. You shouldn’t ignore this because as we know, unmethylated patients did not respond much different than the ECA comparators or known historical trends. The other issue which is CONSISTENTLY ignored by the bearish is that Germany was the only country from which typically early eventing low absolute lymphocyte patients were enrolled from. These patients VERY likely helped create the early eventing seen in the graphs you reference. This is also one part of the reason why I believe that SOC/placebo enrollment was stopped by German intervention that FDA agreed to. That screening halt caused an initial uproar because the German translation on their clinical trials site did not distinguish between a screening halt and a trial halt. There was a mad scramble to get that clarified once the German announcement was shared on an investor forum and no public comments had come from NWBO or FDA yet at that point. There was also never public explanation about why Germany kept out their SOC/placebo patients by Germany or NWBO and German enrollment numbers were never given but they were the last to enroll and had been enrolling since second half 2014 up to about June of 2015 when the blinded look was disclosed. When Fraunhofer made the statement that the trial had been enrolled to the point statistically necessary and that point included 17 missing SOC/placebo patients this confirmed that an efficacy analysis had been done. NWBO declared their blinded look but the DSMB likely had the unblinded look that led to the screening halt AND the conclusion that Fraunhofer was made aware of because they were a trial site that was affected by the screening halt. Hence, they knew that because enrollment continued for the treatment arm and not for SOC/placebo, which caused a weakened powering of the trial, that the trial had been affected by a statistically significant correlation to treatment and intervened upon accordingly.
Anyone can say this is speculation but I guarantee that low absolute lymphocyte count patient enrollment affected this trial in a way that many did not expect. Ever notice that the full and clear low absolute lymphocyte count data along with complete enrollment data from country of origin was never publicly shared?; ). They did what they could to protect long term trial data accumulation and keep it clean. Les even tried to mislead about the enrollment discrepancy to do this as investors had already begun sniffing out the reason for the screening halt. There would have been no need for Les to comment like he did about the enrollment discrepancy if there was another reason for the halt. Best wishes.
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