Qinlock: how long were the pivotal tox studies?

“To assess its safety, the Applicant conducted GLP‐compliant toxicology studies of daily oral administration of ripretinib up to 13 weeks in Sprague Dawley rats and Beagle dogs.”

“Ripretinib was evaluated in repeat dose toxicity studies in rats and dogs (14 days, 4 weeks with 4 weeks recovery, 13 weeks with 4 weeks recovery).”

“The oral route of administration was utilized in all pivotal toxicology studies to match the intended clinical administration route.”