De IV. A ver si lleva esa validacion en EU....aunque early 2021 entiendo que puede ser durante Q1 lo cual aun es un rango de tiempo suficiente para consumir algo mas de nuestra paciencia.
Excerpt from Piper 6Jan2021 AMRN Research Note re Vascepa EU Opportunity
Piper held an expert call with Dr. John Kastelein, PI of the STRENGTH trial and Professor of Medicine at the University of Amsterdam. The specific EU discussion summary follows:
EU is a large market for CV therapies and can be targeted with a strong, focused commercial approach
With potential EU approval of Vascepa in early 2021, Dr. Kastelein outlined the important considerations for entering the EU market, including differences between dyslipidemia management in the U.S. vs. EU, and enthusiasm for omega 3's among EU cardiologists. Importantly, Dr. Kastelein believes that Vascepa will receive approval for the same label that it has in the U.S., which is for CV risk reduction in statin-treated patients with TGs > 150 mg/ dL. To get an idea of the EU market appetite for omega 3's, Dr. Kastelein noted that current treatment options for TG lowering include fibrates, gemfibrozil, and fish oils, compared to niacin, fenofibrate, and omega-3's in the U.S. Additionally, Lovaza is a DHA/EPA combo drug approved in the EU, although it increases LDL-C levels and does not have a high EPA concentration. Therefore, given Vascepa's compelling CV outcomes dataset in comparison to Lovaza and Lovaza's generic competitors, Dr. Kastelein believes that Vascepa will be reimbursed in the EU. To reach the EU market, which is focused on cardiologists, AMRN will need to have trained, high- quality sales representatives who can target data-driven cardiologists to raise enthusiasm for Vascepa, in addition to regional outreach into the largest EU markets (France, Germany, Spain, UK) for a successful commercial launch. Furthermore, Dr. Kastelein also noted that up to 30% of patients in the clinic who have adequate LDL-C control may still have TGs 150-200 mg/dL, and could benefit from Vascepa. Therefore, Dr. Kastelein is convinced that the EU market size is immense, and that the size and efforts of the sales force will be the drivers of commercial success. Therefore, if Vascepa receives reimbursement in the EU and has a strong commercial plan and team, then Dr. Kastelein believes hat it will be highly utilized given the massive market in the EU.