Grace Therapeutics said the U.S. FDA issued a complete response letter for its GTx-104 NDA in aneurysmal subarachnoid hemorrhage, delaying the company’s bid to update the standard of care. The FDA’s CRL cited manufacturing and nonclinical deficiencies rather than concerns about efficacy or safety. Grace specifically pointed to packaging leachables, nonclinical product toxicology risk assessments, and manufacturing deficiencies at its contract manufacturing organization. The company said it will request a Type A meeting with the FDA to clarify the path forward and next steps. For developers in critical-care neurology, the message is clear: even when the clinical signal is positive, manufacturing and product quality requirements can become the gating item for regulatory resubmissions.