1) The approach to FDA must be holistic. REDUCE-IT extended Vascepa’s potential to the CVD space.
2) Amarin might need to leverage the data of Mochida which has never claimed a CVD indication.
The patent moat around LR-EtEPA will block generics in the CVD space, while an FDA authorization to operate in the VHTG sphere will make their life tougher.
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