Elite Pharmaceuticals Inc (ELTP): They wanted more than that as another tr...

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Elite Pharmaceuticals Inc (ELTP)

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Re: Steges post# 208495

Thursday, 06/30/2016 6:30:33 PM

Thursday, June 30, 2016 6:30:33 PM

They wanted more than that as another trial had to be completed. During the adcom, doctors testified that an 8 year old could perform the simple procedure. What I want to reiterate is that the FDA initially approved their trial design & plan and then said they had to do another.

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