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Wednesday, January 16, 2019 5:24:09 PM
The company reported "about 300 enrolled" in August 2015. Only 31, or more probably 32, were enrolled after that. The 17 missing SOC/placebo slot enrollees of the planned for 348 patient enrollment were not ever allowed in but FDA and NWBO could not come right out and say this due to the need to protect trial integrity. This would be especially true if the Germans wanted their SOC/placebo patients stealthily crossed over to treatment arm before a progession event occurred due to perceived ethical concerns. I am not sure this happened but I can't rule it out completely either. The Germans claimed to have improved L. How could they know this unless they saw an improvement by way of something like shipping records revealed to German regulators by a sequestered NWBO rep. Hush, hush stuff. No need for a true unblinded look unless FDA said that this counted as such. Best wishes.
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