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Re: Bouf post# 281671

Saturday, 06/20/2020 2:10:00 PM

Saturday, June 20, 2020 2:10:00 PM

Post# of 427141
B-

the problem we have is that AMRN did not present an expert who testified as to the proper statistical interpretation of the Mori and Kur studies.

As an example (2-16-cv-02525-MMD-NJK - Doc 264):

Q How would a person of ordinary skill in the art determine the effect of EPA alone on LDL cholesterol, given the results in Kurabayashi?

A Well, what you can conclude in this study is that in a patient treated with estriol, that EPA intervention lowers the LDL cholesterol relative to a person who is taking estriol that didn't get the EPA. So in other words, this is -- for this specific population where both groups were treated with estriol, EPA lowers the LDL cholesterol in that -- in that particular

Q And

A -- group.

.
.
.

Q But -- but it's fair to say from the results presented in Kurabayashi that EPA did not, in a statistically significant way, reduce LDL-C cholesterol compared to control?

A Okay. I'm having to look at the figure legend here, because I think this is a fairly technical point. Yes, okay, I think that's reasonable conclusion. It looks like there were similar reductions in LDL cholesterol in both groups.

Q Right. Numerically, estriol alone reduced LDL-C to a greater extent than estriol plus EPA, correct?

A Well

MR. REIG-PLESSIS: Objection to form.

A -- I think the correct interpretation is there's no statistical difference between the two groups.

Q (BY MR. SIPES) Right. The -- which is to say the addition of EPA to estriol did not make any statistically significant difference on LDL-C?

A I think it would be correct to say that in this particular study in these patients, yes.

Best,
G

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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