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Get an API key — free tier: 10,000 calls/dayGrace Therapeutics announced the FDA did not identify safety or efficacy deficiencies after a Type A meeting, clearing clinical pathways for GTx-104. The good news is offset by the need to resolve manufacturing compliance issues.
View filing at SEC.gov →Grace Therapeutics announced it received a Complete Response Letter from the FDA for its GTx-104 new drug application with issues related to manufacturing controls and non-clinical data, but no clinical deficiencies. The company has scheduled a Type A meeting with the FDA to clar
View filing at SEC.gov →