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Re: Number sleven post# 367035

Saturday, 01/22/2022 9:22:53 AM

Saturday, January 22, 2022 9:22:53 AM

Post# of 426489
sleven.."Inclusion Criteria o the MD2119 study"

1.Participants diagnosed with hypertriglyceridemia.
2.Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL"

The second criterion looks like the CVD indication, but I did not see mention of previous CVD as a criterion for participating in the study...I am, however, assuming that Mochida applied for approval of both the HTG and the CVD indications in their submission to the FDA in Japan...i.e. on the basis that Jelis and R-IT had previously proved the efficacy of EPA in CVD.

I would also assume that the U.S. FDA would accept the new formulation for both indications...as will the USPTO
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