Ohtuvayre: how long were the pivotal tox studies?

“The Division noted that in the 40-week dog study (Study #PL15XK), a no observed adverse effect level (NOAEL) was not established with respect to coronary artery vasculopathy.”

“As listed in Table 39, general toxicity studies with ensifentrine were conducted in rats and dogs with dosing durations up to 6 months and 9 months, respectively.”

“Coronary artery vasculopathy findings associated with hemodynamic changes (i.e., increased heart rate and decreased blood pressure) were observed in repeat-dose inhalation toxicology studies (from 6-week to 40-week) in dogs.”