Who says the FDA has delayed anything further. They gave Elite their guidance and Elite recently finished 2 trials - 1 for labeling if I'm not mistaken. And Elite said they are waiting on the FDA to okay their protocol.
I've never heard of the FDA okaying a Phase III trial protocol before. I'd rather wait for the FDA's feedback and get it right the first time. We were told around 7 weeks from the last PR. So I imagine the efficacy trial begins sometime between June 16-30. Until then we wait per the norm in the land of Pharma\FDA.
Nothing unusual but FDA TIME - par for the course.
Truth is that the FDA has never recognized Elite as having the solution for the problem. Someone tried to read between the sky and the earth and pulled out some bs quality speculations or outright exaggeration. Does anyone have a link to the FDA recognizing Elite's product? Don't think so; and NH is not creditable at any level.