Posted by Michael Wonder on 09 Sep 2025
Saol Therapeutics receives complete response letter from FDA for SL1009 (DCA) for the treatment of pyruvate dehydrogenase complex feficiency
8 September 2025 - Saol is seeking a path forward with the FDA that does not require an additional trial
Saol Therapeutics today announced that the US FDA has issued a complete response letter regarding its new drug application for SL1009, sodium dichloroacetate oral solution for use with a proprietary genetic test, for the treatment of an orphan paediatric mitochondrial disease, pyruvate dehydrogenase complex deficiency.
