Balversa: how long were the pivotal tox studies?

“Repeat Dose Toxicology Studies: The Applicant conducted oral repeat-dose general toxicology studies (up to 13 weeks) of erdafitinib in rats and dogs.”

“Rats and dogs were selected as relevant species for the pivotal 1- and 3-month repeat-dose toxicology studies since erdafitinib was shown to be pharmacologically active in both animal species.”

“Repeat-dose oral toxicity was evaluated in albino Swiss mice dosed for up to 2 weeks, in Sprague-Dawley rats and Beagle dogs dosed for up to 3 months.”