Revtorpyk: how long were the pivotal tox studies?

“Repeat-dose toxicity studies were conducted with gedatolisib in Sprague Dawley rats and Beagle dogs up to approximately 1-month duration using an every 4-day dosing schedule (8 total doses) and up to approximately 3-month duration using the clinical dosing schedule of once weekly for 3 weeks on followed by 1 week off; both durations were followed by a 12-week recovery period.”

“Repeat-dose toxicity studies were conducted with gedatolisib in Sprague Dawley rats and Beagle dogs up to approximately 1-month duration using an every 4-day dosing schedule (8 total doses) and up to approximately 3-month duration using the clinical dosing schedule of once weekly for 3 weeks on followed by 1 week off; both durations were followed by a 12-week recovery period.”

“Administration of gedatolisib by 5-minute intravenous (IV) infusion for 8 doses (1 dose/4 days) at 10 mg/kg to male and female rats resulted in:”