Nail on head there pledge. It's precisely what SI was referring to in the webinar.
But placebo is there for sound clinical reasons. It's just that in this case, the reason for a placebo is obviated when you have such a high mortality rate, because those kids on placebo are 80% going to DIE.
It's why I have been finding it very difficult to not break out into actual swearing at the FDA position. I feel fairly confident some kind of outbreak did occur in MSB homes and offices. Only guessing.
MSB to dispute FDA finding in Type A meeting, page-483
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