Rozlytrek: how long were the pivotal tox studies?

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”

“considering that the majority of toxicology studies, including the pivotal 13-week rat and dog studies, tested the Form II (A) also used in clinical trials, results from toxicology studies are considered reliable for extrapolation to humans.”

“The studies were carried out primarily with oral administration, which is the proposed clinical route of administration. Pharmacokinetic analysis following repeated doses was performed in pharmacology studies in mice and in all repeated-dose toxicology studies.”