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An FDC or “new and improved self-emulsifying formulation” would definitely be a better product BUT insurance companies will simply refuse to cover it if it is 1 cent more than gV. The company has been very clear, old and new management, the FDC is only of value in EU as a way to extend the market once patents expire or to negate inevitable price reductions by offering the FDC for the same price as V in later years.
The US market is 100% completely GONE beyond competing with generics on price. Nothing can put the genie back in the bottle. If they successfully sue Hikma, then Apotex will pick up all their generic prescriptions and nothing will change for Amarin. Apotex launched silently. No PR, no marketing, nothing. They make a product to serve the VHTG market and if the consumer decides to violate the patents and use for CVD because their choices were gV for $10 or V for $300 then the Pt needs to be sued (or maybe their insurer), not Apotex.
Gone, gone, gone.
The company, old and new, KM and Saint Denner, have both CLEARLY said the future is the EU. They need to maintain US sales long enough to fund EU roll out until they are cash flow positive in EU, which will be at least another year (or 2)- which is why the SP is $1.30 (just like when the old Amarin was in charge) and will remain there until reliable revenue.
It took 2 1/2 years from Canadian V approval until government coverage and the start of revenue. EU is following the same timeline
(Disclaimer, Canada has a slightly different system where private insurance also covers a substantial percentage of people. Most employed people between 25 and 65 are covered by private insurance and 90% of private insurance plans covered V almost right after approval. In Canada, private insurance is required to cover all medications once approved so not at all like US private insurance that, 12 years later, still frequently doesn’t cover V)
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