Byfavo: how long were the pivotal tox studies?

“Pivotal 4-week repeat-dose toxicity studies with 2-week recovery groups in minipig and monkey are reviewed in detail in sections 6.2.1 and 6.2.2.”

“Pivotal 4-week repeat-dose toxicity studies with 2-week recovery groups in minipig and monkey are reviewed in detail in sections 6.2.1 and 6.2.2.”

“Repeated dose toxicity studies, up to 4 weeks duration, have been conducted in cynomolgus monkeys with administration of remimazolam by intravenous bolus and by intravenous infusion.”