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biosectinvestor

07/01/20 11:00 PM

#293173 RE: CogDiss 1188X #293171

I have always believed the partial halt was driven by German ethics in trials as they have the NAZI history with experimentation and take that stuff very seriously. One of my very early posts here was on that subject and my conviction that it was driven by a German ethical concern for placebo patients having their treatment delayed and therefore being potentially harmed by that delay.
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Doc logic

07/02/20 3:30 PM

#293296 RE: CogDiss 1188X #293171

CogDiss1188X,

What I wrote is my very strong suspicion based on the evidence as follows:

1) The Germans never acknowledged full enrollment nor gave their completed enrollment numbers and yet all planned for treatment arm patients were enrolled in this trial

2) Fraunhofer claimed multpile times to have "optimized" L

3) Fraunhofer claimed to have enrolled only to the point "statistically necessary"

4) The German cohort is the only cohort with low absolute lymphocyte count patients as far as anyone can determine

5) A posted conversation shared on this board between a German woman and her husband's oncologist indicated to her that her husband had been randomized to control but not allowed to enroll during the screening hold period. When asked about L availability he
suggested to her that 2020 would be the year.

6) The Germans are perhaps the most stringent with enforcement of ethical interventions due to their history. With low absolute lymphocyte count patients being monitored very closely by NWBO and their obvious interest in subgroup analysis coupled with probable German "optimization" and understanding gained from Direct Phase 1 about activation/maturation being linked to optimum DC cytokine production before the first German patient enrolled, it is not unlikely that a strong link to at least a subgroup was found. If that subgroup was not accounted for in the trial ie IDH-1 status then the Germans would not allow any further SOC/placebo into the trial knowing that they could be putting patients at risk of receiving a known lessor treatment with SOC/placebo especially when the treatment could by applied for through the Soeciaks program in Great Britain. The Germans would have disclosed the reason for this type of hold if they imposed the hold rather than NWBO.
Best wishes.