Relyvrio: how long were the pivotal tox studies?

“Pivotal toxicity studies consisted of daily oral dosing in SD rat (840 mg/kg AMX0035) and Gottingen minipig (845 mg/kg AMX0035) for 26 or 39 weeks, respectively.”

“Pivotal toxicity studies consisted of daily oral dosing in SD rat (840 mg/kg AMX0035) and Gottingen minipig (845 mg/kg AMX0035) for 26 or 39 weeks, respectively.”

“In rat, NaBP/TUDCA were administered orally (gavage) at doses of 0/0, 250/83.32, 750/250, and 1000/333.28 mg/kg QD for 28 days, and AMX0035 was administered orally (gavage) at doses of 0, 250, 420, and 840 mg/kg QD for 26 weeks (+ 28-day recovery period).”