From Allen Brzozowski @ajbrzski twit - FDA Briefing Doc points to positive AdCom - P. 103-104 par attached.
Last paragraph in Briefing Doc,pp103-104,points to positive AdCom. The mineral oil discussion is ridiculous!
Vascepa offers advantages over existing TG-lowering therapies. One of key benefits of Vascepa therapy is the absence of a significant increase of LDL-C, since fibrates and omega acid complex mixtures that contain EPA+DHA are known to increase LDL-C levels in hypertriglyceridemic patients (Goldberg 1989, Bays 2008). A further benefit of Vascepa therapy is that it does not interfere with glucose control. While small numerical elevations were see in FPG, they were not statistically significant or clinically meaningful. The more accurate markers of glucose control (insulin, HbA1c, HOMA-IR) were similar between active and placebo arms.
Patients who are at high risk for CVD who are taking statin therapy and have persistently
AMARIN PHARMACEUTICALS IRELAND LIMITED
Vascepa (icosapent ethyl) Capsules
Briefing Materials for EMDAC
October 16, 2013
high TGs are at-risk and need a safe and effective therapy that can be added to their statin therapy for more aggressive and comprehensive lipid control. If approved, Vascepa would fill an important unmet medical need for these patients.
So sloppy with your research. No wonder you keep falling into horrible stocks. You skim message boards and tweets for anything to support what you hope is true and then go whole hog into a very risky stock.
Maybe you need to step back and read more about a company and its one and only product before dumping your life savings into it.