Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026
FDA confirmed the resubmission is a complete, Class II response to the Aug. 27, 2025 CRL. Saol remains committed to working with FDA toward approval of this treatment for PDCD, a rare, life-threatening mitochondrial disease with no approved therapies. ROSWELL, Ga. and DUBLIN and HAMILTON,...
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