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Count: 25 Multiple Dose Vials Per Tray

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

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As the solution contains 0.9% benzyl alcohol as a bacteriostatic preservative, the risk of microbial contamination in the vials is minimal