Viltepso: how long were the pivotal tox studies?

“Viltolarsen was administered by IV injection for 12 weeks (+4-week recovery) and 39 weeks (+8-week recovery) at doses of 0, 60, 200, and 600 mg/kg QW and 0, 10, 60, and 360 mg/kg QW, respectively.”

“The pivotal IV toxicity studies were conducted in male CD-1 mouse (13 and 26 weeks) and male cynomolgus monkey (12 and 39 weeks).”

“In the pivotal study, viltolarsen (0, 15, 60, 240, and 1200 mg/kg) was administered weekly by SC injection on PND 7 and by IV injection on PNDs 14 through 70.”