Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying a potential update to care for aneurysmal subarachnoid hemorrhage. The agency’s concerns were described as manufacturing and nonclinical deficiencies rather than efficacy or safety issues. Grace cited product leachables for packaging, gaps in nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturing organization. The company said it will request a type A meeting with the FDA to clarify the path forward. The CRL highlights how late-stage execution and quality documentation can become the gating factor for programs even when clinical signals are positive, and it adds near-term uncertainty to timeline expectations for the first-in-decades attempted standard-of-care change.