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0.0515463917525774 0.0309278350515464 0.0206185567010309 0.0514432989690722 0.0514432989690722 0.0104123711340207 0.103092783505155 0.0515463917525774
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Evoke Pharma Completes Manufacturing of Commercial Scale Registration Batches of Gimoti™

Evoke Pharma, Inc. (EVOK) 
Last evoke pharma, inc. earnings: 11/7 08:30 am Check Earnings Report
Company Research Source: GlobeNewswire
SOLANA BEACH, Calif., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has completed manufacturing commercial scale batches of its product candidate Gimoti (metoclopramide nasal spray) with its partner Thermo Fisher Scientific, a leading global contract development and manufacturing organization that specializes in the preparation, fill and finish of nasal spray products. Evoke plans to collect Chemistry, Manufacturing and Controls (CMC) data from these registration batches, which were requested in the complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). These data will be used to support the proposed acceptance criteria for performance characteristics and device quality control and will be included in Evoke’s planned resubmission of the 505(b)(2) New Drug Application (NDA) for Gimoti. “We are pleased to complete anot Show less Read more
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