Defitelio: how long were the pivotal tox studies?

“or vehicle was administered as a 2-hour intravenous infusion at a rate of 2.5 mL/kg/hour four times daily for 13 consecutive weeks.”

“Rats were given defibrotide by continuous iv infusion for 9 weeks. Dogs were given defibrotide by i.v. infusion of 2 h duration every 6 hours 4 times daily for 13 weeks.”

“To support the current application, single-dose and repeat-dose toxicity studies were performed in rats and dogs with intravenous infusion.”