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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
Identity and purity of test article
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Lewy AJ, Bauer VK, Hasler BP, Kendall AR, Pires ML, Sack RL
Units shown for U-100 insulin syringes
With a half-life of approximately six days, missing one dose reduces but does not eliminate blood levels
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