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Home » Evoke's Gimoti evinces doubts about readiness for FDA review
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Evoke's Gimoti evinces doubts about readiness for FDA review

March 5, 2019
By Michael Fitzhugh
Questions about the relevant efficacy, chemistry and production of Evoke Pharma Inc.'s diabetic gastroparesis candidate, Gimoti (metoclopramide), headlined a multidisciplinary review (DR) letter from the FDA, throwing into question whether a review of the drug will be completed by its April 1 PDUFA date. The company said it plans to respond to the deficiencies raised in the letter to allow time for potential FDA review prior to the PDUFA date. Nonetheless, investors sent company shares (NASDAQ:EVOK) down 57.2 percent to $1.30 on Monday.
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