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Re: jessellivermore post# 237718

Monday, 12/30/2019 1:08:18 PM

Monday, December 30, 2019 1:08:18 PM

Post# of 423564

My point is experts would understand in most cases the drug would be treating a chronic condition and would require long term (greater than 12 weeks) and likely indefinite use in degenerative processes..and this would be understood by doctors treating these conditions (eg. Atherosclerosis) regardless if the label did not specifically say (use for more than 12 weeks)..

The R-I trial ran for more than six years...and enrollees were required to continue taking Vascepa for the duration..It is interesting the generics bring in 12 weeks which was the duration of ANCHOR and MARINE..Trials designed to determine Vascepa's effects on blood markers, but not on the disease process...REDUCE-IT suggested meaningful clinical benefits only began to emerge (separation of the arms) at about a year of treatment; suggesting 12 weeks was too short to achieve any therapeutic benefit from the drug



JL,

I think you should forward your thoughts, and a brief bio, to the attorneys handling this case for AMRN. You make some great points here, and I never like to assume that expert witnesses have all the points that *lawyers and judges* will find persuasive.

I've worked with a lot of lawyers over the years, and the best ones appreciate these kinds of insights--abd ebsure they are put to effective use. As I said, perhaps redundant, but would not want that assumption to be wrong, and not have these shared.

Thanks for all the knowledge and analysis you share here.

Happy New Year!
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