Cyfendus: how long were the pivotal tox studies?

“The treatment-related effects were very similar in the single dose toxicity study as well as in the repeat dose toxicity study in adult (full human dose given on Study Day [SD] 1, 15, 29) and juvenile rats (1/5th of the human dose given on SD 21, 28, 35).”

“The applicant conducted a single-dose acute toxicity study, a repeat-dose safety toxicity study, a pre- and post-natal developmental and reproductive toxicity (DART) study, as well as a juvenile repeat-dose toxicology study. All these GLP-compliant toxicology studies were performed in rats, and animals were dosed with CYFENDUS via IM injection, the intended route for human use.”

“In all studies, animals were dosed via intramuscular (IM) injection, the intended route for human use.”