AstraZeneca Submits Brilinta To FDA, But Review Could Be Lengthy
This article was originally published in The Pink Sheet Daily
Executive Summary
Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) took 18 months to approve, and the unexplained lack of effect for ticagrelor in North American patients in AstraZeneca's PLATO study is a sure bet for FDA scrutiny.