Galmed Pharmaceuticals announced that the company has completed its End-of-Phase 2 meeting with the FDA and reached general agreement on key aspects of the Phase 3/4 development and registration plan for Aramchol and on the pivotal registration study ARMOR. ARMOR is a Phase 3/4 multinational, multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy, safety and tolerability of Aramchol in subjects with NASH and fibrosis. Galmed previously announced results from its Phase 2b study which were subsequently presented at AASLD 2018.
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