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Re: ramfan60 post# 398573

Tuesday, 01/17/2023 6:41:25 PM

Tuesday, January 17, 2023 6:41:25 PM

Post# of 447408
Ram. this provides more detail
https://rethinkingclinicaltrials.org/news/june-18-2021-the-mitigate-study-insights-from-a-decentralized-virtual-electronic-health-record-based-pragmatic-clinical-trial-andrew-ambrosy-md-alan-go-md/

AMRN needs more clinical trial evidence ( as KM says Real World Evidence ) to raise their Level of Evidence rating ...currently at 11b ( 2 b ) for EU markets such as Germany and France that place a lot of weight on independent trials confirming the risk reduction of the pivotal trial ...R-IT

MITIGATE is the only trial AMRN is funding that can provide this additional CV data .
The CV data is exploratory endpoints and listed as such in clinical trials.gov.
These endpoint results will be followed ...and if they follow them long enough ( say 2 yrs for event lines to clearly diverge )..hopefully AMRN can use them to increase their Level of Evidence rating .

By the way ..from the Oct CC
Reimbursement decisions due from France , Italy and Spain by end of 2022 or early 2023

Kiwi
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