Grace Therapeutics gets FDA Type A minutes; no clinical deficiencies; adds U.S. manufacturing site for GTx-104

Grace Therapeutics, Inc.

• FDA did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data.
• CRL items relate to cGMP compliance at contract manufacturer, leachables data, and excipient toxicology risk assessments.
• Company pursuing dual-source manufacturing strategy, adding a U.S.-based contract manufacturer.
• No single path to resubmission designated; resubmission may be supported by either or both manufacturers.
• STRIVE-ON trial met primary endpoint with 19% reduction in clinically significant hypotension vs oral nimodipine.