Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
Grace Therapeutics received a Complete Response Letter from the FDA for GTx-104, citing issues related to Chemistry, Manufacturing, and Controls (CMC) as well as non-clinical information. Notably, the FDA did not request additional clinical data, and the company believes the cited items regarding leachables, toxicology, and manufacturing deficiencies can be addressed in a resubmission.
Key figures
- Drug Name
- GTx-104
- Phase Of Trial
- Phase 3
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