Piqray: how long were the pivotal tox studies?

“The toxicity of alpelisib after repeated oral administration was studied in rats and dogs with dosing up to 13 weeks.”

“Daily oral administration of alpelisib was assessed in repeat-dose toxicity studies for up to 3 months in rats and dogs, consistent with the clinical route of administration and intended dosing schedule. The pivotal repeat-dose toxicology studies were conducted in compliance with Good Laboratory Practice regulations (21 CFR part 58).”

“Daily oral administration of alpelisib was assessed in repeat-dose toxicity studies for up to 3 months in rats and dogs, consistent with the clinical route of administration and intended dosing schedule.”