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8 months ago
BRIEF-Evoke receives positive NDA submission guidance from US FDA for Gimoti
December 15, 2016 / 9:31 PM / 8 months ago

BRIEF-Evoke receives positive NDA submission guidance from US FDA for Gimoti

Dec 15 (Reuters) - Evoke Pharma Inc

* Evoke Pharma - During review and labeling negotiations, safety and efficacy data from completed Gimoti studies may be used to support info included in Gimoti label

* Evoke Pharma - FDA agreed demonstration of equivalent exposure to listed drug, reglan 10 mg, in pharmacokinetic trial could serve as portion of NDA for Gimoti

* Evoke Pharma - Upon demonstration of appropriate exposure in a PK trial, co will submit PK data and prior clinical studies to agency for review in Gimoti nda

* Says FDA agreed that no new efficacy or safety study would be required, if bioequivalence criteria were met

* Evoke receives positive NDA submission guidance from US FDA for Gimoti Source text for Eikon: Further company coverage:

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