Komzifti: how long were the pivotal tox studies?

“The GLP-compliant repeat-dose toxicology studies with up to 13 weeks of dosing were conducted in mice and dogs with animals dosed twice daily via oral gavage.”

“The definitive nonclinical safety program was comprised of 28-day and 13-week toxicity studies in mice and dogs, as well as the standard battery of genetic toxicology studies, in vitro and in vivo phototoxicity studies, and an embryofetal development study in mice.”

“The GLP-compliant repeat-dose toxicology studies with up to 13 weeks of dosing were conducted in mice and dogs with animals dosed twice daily via oral gavage.”