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Will Lar

08/29/20 10:32 PM

#293761 RE: Chemist2 #293710

Chem - based on the changes from the baseline, I believe it's okay to claim both regression (within V's arm) and progression halt (btw arms).

The whole confusion started with the fact that they didn't report the primary endpoint as a percentage. There may be a good reason for it. They somehow reported the % changes within each arm even though it's not part of either primary or secondary endpoints. Readers tend to gravitate to a single number better than a set of values. Hence the 17% misinterpretation.

Regardless it's neither correct nor professional for Amarin to make such a mistake in the PR. These kinda of stuff typically need to be reviewed and approved by regulatory affairs before hitting the wire. It seems that they really rushed it, probably because they wanted to disclose this before its appeal hearing or to meet the conference's timeline. Or it can be as simple as the PR person wanted to get it out quickly so that he or she can go back to enjoy the weekend.