Xenleta: how long were the pivotal tox studies?

“No systemic target organ was identified in studies up to 13 weeks of administration.”

“In rats, local intolerance was not observed with a formulation containing 1.875 mg/mL lefamulin dissolved in 10 mM citrate-buffered saline when injected every 12 hours for 13 weeks. In a 13-week repeated dose toxicity study in monkeys”

“In repeat dose studies in both rats and monkeys, local intolerance was dose limiting by both oral and IV routes of administration.”