Replies to post #393546 on Amarin Corp Plc (AMRN)

[north40000]

Would Amarin be needlessly spinning its wheels in even thinking about an authorized generic?

If I am correct in my earlier statements today, #393539, that 1) the generics have submitted no clinical trial evidence to the FDA that shows their respective products are therapeutically equivalent to Vascepa in reducing risk from CVDs, and 2) FDA has not approved any generic companies’ NDA, ANDA, sANDA to market their respective generic Vascepa products for reduction of risk from a cardiovascular disease, then the generic companies companies have no business being in that market in the first place. Patient lives are the issue. A petition to the FDA Commissioner, a cardiologist, to issue at least a warning letter to each generic company to restrict sales and marketing to the “approved ANDA indication”, reduction of triglycerides above 500 mg/dL, is warranted
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[ralphey]

This is the modus operandi of insurance companies backed by the full blessing of the US Government to restrict Health Care expenditures to under 15% of GDP - currently approaching 20% - lil ole AMRN is NOT going to change this - Denner is coming to that realization