exwannabe,
Your thesis collapses when you say the regulator will not allow new patient enrollment because at the time of the screening halt around June 2015, 299 or 300 were enrolled and enrollment continued from June until November but only in the treatment arm. SOC/placebo ended up shorted by 17 which constituted just more than a 2:1 treatment to SOC enrollment rate remaining to be done after the halt. Almost 100% of patients at that time were being enrolled from Germany. This means the Germans were keeping patients out of the trial likely for ethical reasons assuming they knew that SOC/placebo was a lesser treatment. By law they do not allow patients to be given a lesser treatment. Fraunhofer made this pretty clear when they stated in their 2015 annual report that patients were only enrolled to the point statistically necessary. The findings in the peer reviewed article in JAMA Oncology basically backed the rational for the halt being due to benefit with published results that showed the best advantage went to earliest treated patients even though rGBM patients had benefit as well. Germany also was the only jurisdiction that had early eventing low absolute lymphocyte count patients enrolling meaning that identifying benefit from treatment would be recognized earlier in this group of patients. Go phish!; ). Best wishes.
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