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Post# of 429479
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Re: ORBAPU post# 268436

Thursday, 04/23/2020 2:05:04 PM

Thursday, April 23, 2020 2:05:04 PM

Post# of 429479
Additionally, the label they would be seeking is based on MARINE, so that’s the data they would need to demonstrate bioequivalency to. I’m not sure how they would handle bioequivalency claims for an outcomes-based trial like Reduce-It, as opposed to a biomarker trial like MARINE. I guess they’d look at serum EPA as the relevant information.
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