Ojemda: how long were the pivotal tox studies?

“Repeat-dose toxicity studies of up to 3 months in rats and monkeys with QD, Q2D, every 3 days (Q3D), and/or once weekly (QW) PO dosing were performed.”

“Repeat-dose toxicity studies of up to 3 months in rats and monkeys with QD, Q2D, every 3 days (Q3D), and/or once weekly (QW) PO dosing were performed. Since dose range-finding pilot studies with daily dosing showed intolerability in both species, the Q2D regimen showed improved tolerability.”

“The oral route was chosen since this is the intended clinical route.”