Cypsedo: how long were the pivotal tox studies?

“No drug accumulation was observed in rats and beagle dogs after 7 or 14 injections given every other day over 2 or 4 consecutive weeks, respectively.”

“The Applicant conducted 14- and 28-day repeat-dose toxicology studies in rats and dogs with administration of the test article every other day.”

“while all the repeat-dose studies with IV bolus injections reached Cmax levels that were much lower than the human Cmax at the HID”