Besponsa: how long were the pivotal tox studies?

“The Applicant conducted repeat-dose toxicity studies of up to 6 months duration in rats and cynomolgus monkeys to investigate the chronic toxicity of inotuzumab ozogamicin;”

“In the 6-month cynomolgus monkey study, inotuzumab ozogamicin was administered IV at doses of 0.5, 1.5, or 5 μg/kg once weekly.”

“the studies were conducted using the intravenous (IV) route, consistent with the intended clinical route of administration.”