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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
Supplement Facts: Serving Size: 1 capsule Servings Per Container: 60 Amount Per Serving: Milk thistle seeds extract: 124 mg (of which silymarin 99.2 mg) L-ornithine hydrochloride: 100 mg Soy lecithin: 71.5 mg (of which phosphatidylcholine 25 mg) L-methionine: 30 mg L-glutathione: 25 mg Inositol: 15 mg Vitamin E: 5 mg -TE (42% RI) Vitamin B1: 2 mg (182% RI) Vitamin B2: 2 mg (143% RI) Vitamin B6: 2 mg (143% RI) *RI - Reference Intake Ingredients: Soybeans oil, black capsule shell [gelatin, humectant (glycerol), water, colour (E172)], milk thistle seeds extract (Silybum marianum (L.) Gaertner
ACS Infectious Diseases
Prescribing information (Eli Lilly, 2025)
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