So if NEW2 score was primary endpoint rather than secondary endpoint and had P=0.02 with marked decreased SAEs, that would be insufficient and not robust for what reason?

Placebo controlled, double -blinded, randomly assigned studies are the gold science of medicine. Is there a platinum standard of which I am unaware?

You stated you are a physician, but have been unable to articulate a logical basis for your statements that "hopefully FDA gives us a pass"

We are waiting................