Defencath: how long were the pivotal tox studies?

“Although neither of these studies were considered adequate for a pivotal nonclinical toxicology study to support human drug development (exposure to taurolidine was not sufficient to explore possible toxicity and identify potential target organs)”

“Thus, additional acute or repeat-dose general toxicology testing in animals was not required for the components of Defencath.”

“A single dose intraperitoneal study conducted with Defencath in mice and a 14-day repeat-dose intravenous study conducted in rats (discussed in additional detail below) did not reveal signs of toxicity.”