Pasatru: how long were the pivotal tox studies?

“In a chronic (26-week) monkey study, garetosmab caused reversible, non-adverse minimal to moderate seminiferous tubule degeneration that did not impact sperm function.”

“Reproductive organs and fertility-related parameters were assessed in sexually mature cynomolgus monkeys in a 26-week study in which garetosmab was administered intravenously once weekly at doses up to 50 mg/kg”

“In 5-week toxicology studies in male rats, intravenous administration of garetosmab resulted in adverse effects including inflammation, granulomas, and epithelial degeneration in the male reproductive tract (testes, epididymis, and efferent ducts)”