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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
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Potential concerns include effects on angiogenesis that theoretically could influence tumor development or progression, though preclinical studies show context-dependent effects that inhibit pathological angiogenesis in some tumor models
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