Grace Therapeutics said the FDA issued a complete response letter (CRL) for its GTx-104 NDA for aneurysmal subarachnoid hemorrhage, delaying the company’s efforts to update the standard of care. Importantly, Grace said the CRL cited manufacturing and nonclinical deficiencies rather than concerns about efficacy or safety. The FDA highlighted issues including leachables for product packaging, nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturing organization. Grace plans to request a Type A meeting with the agency to clarify the path forward and determine next steps. For investors and clinicians watching neurocritical care therapies, the update is a reminder that the regulatory process can hinge on quality systems and risk assessments even when earlier clinical signals are positive. The next catalyst will likely be how quickly Grace can resolve the specified technical gaps.