At what point does someone take action to fix this trials process? Any responsible FDA manager should call themselves out. They should admit they spend and enormous amount of money with limited resources running trials process which by any standard of competency which often lead to failure.
BTW, these would be the same people who manage their queue by telling future trial sponsors they will have to wait at least 6 months before we can even begin to look at you protocol. And they get away with it.
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