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28 note to investors, William Blair analysts wrote that Applied Therapeutics suspects the CRL was related to the efficacy package as opposed to [chemistry, manufacturing and controls] or safety. Results from the Phase III ACTION-Galactosemia Kids study, unveiled in April 2023, showed that govorestat fell short of its primary efficacy endpoint, a composite of four clinical measures designed to assess various domains of galactosemia symptoms

This non-invasive approach identifies whether the symptoms are originating from the wrist, neck, or both

The percentages shown for the solvents indicate their volumetric ratio in the final prepared solution

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Hydroxocobalamin is the form typically used in intramuscular injections for treating B12 deficiency in the UK, as recommended by NICE guidelines