This approval has been a long time coming. Zontivity was once the leading drug candidate in Schering-Plough’s pipeline, but it sank into a deep pothole when the phase-3 data showed it increased major bleeding and mortality for patients with a prior stroke. Thus, patients with a prior stroke are explicitly excluded from the FDA label, which spceifies secondary prevention of MI for patents with a prior MI or existing PAD.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”