Tryngolza: how long were the pivotal tox studies?

“In a 39-week monkey toxicity study that included a 26-week recovery period, olezarsen induced a marked reduction in platelet count (>98% decrease) in a single male animal at the 12 mg/kg/wk”

“The nonclinical evaluation of the safety of olezarsen included repeat-dose general toxicology studies of up to 26 and 39-weeks in duration with 13 and 26-week recovery periods in mice and monkeys, respectively”

“once-weekly SC injections. These studies included 13- and 26-week recovery periods in the mouse and monkey, respectively.”