Elite Pharmaceuticals Inc (ELTP): My hunch was another BE trial would be r...

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Re: jour_trader post# 239152

Monday, 01/16/2017 9:52:03 PM

Monday, January 16, 2017 9:52:03 PM

My hunch was another BE trial would be required but it just seems asinine. You have a Phase 3 trial already proving that the drug works and is safe. Determining a "food effect" would technically be a Phase 1 trial.

www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM340007.pdf

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