April 4, 2017 / 1:12 PM / 4 months ago

BRIEF-Meeting with FDA confirms acceptability of Evoke's proposed trial for Gimoti NDA

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April 4 (Reuters) - Evoke Pharma Inc

* Positive type A meeting with FDA confirms acceptability of Evoke Pharma’S proposed comparative exposure PK trial for Gimoti NDA

* Positive type a meeting with FDA confirms acceptability of Evoke Pharma’S proposed comparative exposure PK trial for Gimoti NDA

* Company believes it will be able to submit NDA for Gimoti by late 2017 or early 2018

* After discussing protocol design of PK trial with FDA, Co plans to incorporate agency's recommendations in final protocol

* Pivotal comparative exposure PK trial will be conducted in healthy volunteers to demonstrate bioequivalence of Gimoti to Reglan tablets

* Preparing to execute PK trial and expects to have results in second half of 2017 Source text for Eikon: Further company coverage:

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