Friday, June 14, 2019 1:01:00 PM
As you know and agree, there are reasons for stirring committees, CRO contractors, ethics/DMC committees and scientific review boards.
For years, our expectation would be that Germany would be more cautious than anyone else of continuing placebos if placebos were not generating long term survivors. I have to believe there was at least one German voice at the DMC meetings reviewing safety data.
I am not a fan of overuse of Occam's razor, but in this case it seems quite appropriate. It goes like this (as you know and also agree).
There were 48 more patients to enroll after the 300th patient.
32 should have been treatment and 16 should have been placebo.
Instead, there was a screening halt, and when we finally learned about full enrollment, there were 17 placebo spots that were expected to be enrolled that were not. 232/232 treatment but only 99/116 placebo.
Occam's razor says timing plus number = placebos were not enrolled at the end of the trial.
Occam's razor says this would need to be kept from NWBO, the public and listed blinded personnel in order to keep integrity until the trial is sufficiently mature to unblind.
Occam's razor also says that while all the critical players may guess at what might be occurring, they are duty bound to talk the talk and walk the walk.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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