Grace Therapeutics (GRCE) announced details of the Company’s Type C meeting with the U.S. Food and Drug Administration. The purpose of this meeting was to obtain FDA feedback on the completed Phase 3 STRIVE-ON safety trial of GTx-104 and its planned New Drug Application submission including clinical, non-clinical, and chemistry, manufacturing, and control requirements. Based on feedback from the FDA, the Company believes that the data and regulatory packages as currently structured will be sufficient for submission of an NDA.
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