Let's be clear, I want to be wrong, I want PEI to have seen the P3 data and approve based on the outstanding things they've seen. But it still seems like it would blow up the entire trial to have data shared and approval before the data is made public.
I want to make sure I'm understanding the scenario you're proposing. Are you saying NWBO made an agreement with the FDA to share interim data with PEI for special approval AND they firewalled an employee to communicate data to the PEI?
If they had an agreement with the FDA to share interim data with PEI, I would have to imagine there is a clause that says the PEI cannot publicly make a decision based on that data as that communicates to NWBO That the data is good (and thus jeopardizes the trial).
And Robert Demeger's Health does not communicate the same thing as German Approval based on P3 data. Demeger is a single data point in a trial (also if he's in the trial he could potentially be in the placebo group), a German Approval based on P3 data says 'phase 3 data in aggregate is good'.
The latter in my opinion would compromise the study.
You don't refute that it is possible PEI based their decision just on P3 safety data and P1/2 efficacy, correct? Please don't take my skepticism to some of your points as being bearish, I appreciate your research and respect your point of view (I just think its overly hopeful for the realities of the trial).
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