Grace Therapeutics receives FDA CRL for GTx-104 NDA; schedules Type A meeting

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 clarify the resubmission pathway for this potential first IV nimodipine treatment for aSAH patients in over 40 years.