Vyondys 53: how long were the pivotal tox studies?

“Title: A 39-week intravenous infusion toxicity study in male cynomolgus monkeys with an 8-week recovery period”

“Toxicology: 12- and 26-week studies in mouse; 12- and 39-week studies in monkey; 4- and 10-week toxicity study in juvenile rat.”

“Golodirsen was administered by weekly injection for 12 weeks (0, 12, 120, or 960 mg/kg IV) or 26 weeks (0, 120, 300, or 600 mg/kg SC); recovery periods were 4 and 8 weeks, respectively.”