Inqovi: how long were the pivotal tox studies?

“A 92 Day Toxicity Study of E7727 Administered via Oral Gavage in Cynomolgus Monkeys Followed by a 21 Day Recovery”

“Cedazuridine monotherapy was assessed in repeat-dose toxicity studies up to 13-weeks/4-cycles in duration in mice (up to 1000 mg/kg/dose) and cynomolgus monkeys (up to 200 mg/kg/dose).”

“The pivotal studies were conducted under GLP-compliance, and the test articles were administered by the oral route following dosing regimens comparable to the planned clinical treatment cycle of 5 consecutive dosing days followed by 23 non-dosing days.”