Edition:
India

FDA Approves PDUFA Fee Waiver For Gimoti New Drug Application


Monday, 5 Mar 2018 

March 5 (Reuters) - Evoke Pharma Inc ::FDA APPROVES PDUFA FEE WAIVER FOR GIMOTI™ NEW DRUG APPLICATION.FDA GRANTED ITS REQUEST FOR SMALL BUSINESS WAIVER OF PDUFA FEE OF ABOUT $2.4 MILLION FOR ITS TREATMENT GIMOTI.COMPANY REMAINS ON TRACK TO FILE GIMOTI NDA NEXT QUARTER.LOOK FORWARD TO POTENTIAL U.S. PRODUCT LAUNCH IN 2019 OF GIMOTI.AS CO REVIEWS 2018 BUDGET, ABLE TO EXTEND CASH RUNWAY INTO OCTOBER 2018. 

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17 Oct 2019