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BRIEF-FDA exempts Evoke from requirement for human factor validation study
February 15, 2017 / 2:07 PM / 10 months ago

BRIEF-FDA exempts Evoke from requirement for human factor validation study

Feb 15 (Reuters) - Evoke Pharma Inc

* FDA exempts Evoke from requirement for human factor validation study

* Evoke Pharma Inc- received a letter from FDA exempting Gimoti from a human factors validation study requirement prior to submission of NDA

* Evoke Pharma Inc- In their written response, FDA determined that an HF validation study is not needed at this time for Gimoti

* Evoke Pharma Inc- Intend to pursue an NDA submission by end of year for Gimoti Source text for Eikon: Further company coverage:

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