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Laurent Maldague

04/12/20 2:34 PM

#265239 RE: jomama9231 #265232

The way I read it, no synergy between EPA and estriol would imply it was EPA alone that caused Apo-B reduction, rather than a synergistic effect between EPA and estriol.

Suppose there was synergy, and suppose EPA + estriol Apo - B reduction WAS statistically sig compared to just estriol (we know it wasn't), then Amarin could argue it wasn't EPA per se, rather a synergistic effect that caused apo-p reduction.

I think we have enough with the factual errors (stat sig + patent official did consider Kura) to win the Apo-B point.

sts66

04/12/20 3:50 PM

#265253 RE: jomama9231 #265232

What bugs me is defendants played fast and loose with Kura's conclusions, made them appear to say something they did not say, left out a critical section at the end of a sentence - sorta like how MSM edits video to make it appear someone said something they actually didn't:


257. The Apo A-II level in the subjects treated with EPA significantly decreased from baseline to week 48, and the Apo B level in the EPA group was significantly lower at week 48 compared to baseline in the EPA group, but not the control group. (Id. at 000003, Table 3.)

258. Kurabayashi states that “The most important finding of this study was that
combination therapy with eicosapentaenoic acid and E3 significantly decreased the serum triglycerides level compared with E3 alone.
Eicosapentaenoic acid has an inhibitory effect on hepatic triglycerides syntheses and secretion and has a stimulatory effect on lipoprotein degradation, resulting in reduced particle size.” (Id. at 000005.)




Defendants did not submit what Kura actually said about Apo-B levels - this is the exact sentence from the Kura paper, underline part is what they edited out:


The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups.