Adbry: how long were the pivotal tox studies?

“The no observed adverse effect level (NOAEL) for tralokinumab in cynomolgus monkeys was 90 mg/kg/week in the 13-week SC toxicology study and 100 mg/kg/week in the 26-week IV toxicology study.”

“The repeat dose toxicity studies included 4-, 13- and 26-weeks studies with weekly IV dosing at levels up to 100 mg/kg and weekly SC injections of up to 350 mg/injection for 4- and 13-weeks.”

“Three IV and two SC repeat-dose toxicity studies were submitted.”