Assuming the patent for Lr-Et-EPA is approved by the USPTO, the FDA may or may not require a new study before approving it for U.S. marketing...If the FDA does require another study, Amarin would probably need to do a smaller and shorter study than the Reduce It study...which the FDA insisted on before approving Vascepa.
Amarn had to mortgage their Vascepa patents to borrow the necessary funds for the Reduce It study...They are in a better position now to do an FDA required study for the new formulation than they were then for Vascepa
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