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Re: tenor15824 post# 154555

Friday, 05/22/2015 3:46:45 PM

Friday, May 22, 2015 3:46:45 PM

Post# of 399480
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.


Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.

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