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dukesking

10/14/19 1:01 PM

#219174 RE: jessellivermore #219169

JL, Thanks. I agree with your post about lipids. I just read AVII's post from 2013 ADCOM vote and it sounds like all of the "NO" voters agree with your sentiments on lipid lowering not equating to CVD event reduction. They rightfully wanted and got their outcomes study. That should bode well for the upcoming ADCOM. Doesn't the entire prescription O3 market stand to lose on any failure of AMRN to receive a positive ADCOM vote and CVD label? I mean if Pharma is behind a concerted effort to derail AMRN, they would essentially be cutting their own throats. I can't imagine that they aren't in favor of a positive outcome so they can piggyback on it. The only winner might be the DS industry and I think that is who is behind the FUD campaign. I believe, as you and others have stated, that the FDA is only concerned over a very broad label and wants to get ADCOM opinions before granting the CVD label. All IMO.

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slimhere

10/14/19 1:03 PM

#219176 RE: jessellivermore #219169

OK....Sorry for the misunderstanding...Going into this AdCom is activating my paranoid side..I'm more worried about our representatives..Giving FDA a shot at us...

I'm worse than I was the last time, which doesn't make sense. Last time, consensus was: do a study like our R-IT, then come back here and we'll be good. I believe that I never got over that the FDA wanted another AdCom, also listening (and believing) to many here saying that the FDA can and will do whatever the hell they want to do, I'm scared. I just don't understand why they (FDA) are toying with human lives..............and how much further will they go.

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Chemist2

10/14/19 7:45 PM

#219250 RE: jessellivermore #219169

Hi JL; I was surprised to see you suggest 1 or 2 or higher for the target value for the EPA/AA ratio. I hope we come to standardize on the AA/EPA
ratio rather than the EPA/AA ratio because I believe most people
can more easily relate to integer values rather than fractions.
My before and after(VASCEPA) values for EPA/AA were from 0.07 to ~0.7
and so the AA/EPA ratios went from 14 to ~1.4.
I don't think we'll see many EPA/AA ratios >1 but
hopefully the REDUCE-IT data will give us some idea for a target ratio
whether we use EPA/AA or AA/EPA. What do you think about this? Best Wishes.
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james murphy

10/14/19 8:10 PM

#219253 RE: jessellivermore #219169

JT said loud and clear 8-8 when adcom was announced on the conf call WE want CVD expansion but didnt mention trigs lowering labeling the whole conf.He was mad .I think the FDA put lower trigs expansion on the table and JT said Shove it and they said back ok LETS PLAY