Hi Laurent ...nice to know U haven't placed me on ignore yet :--) I agree with U regarding Dr Bhatts' comments .
Do U have any thoughts on the Germans current refusal to reimburse for Vazkepa ? They were using Ezetimbe ( Zetia ) as the comparator ...was that based on the Simivastatin / ezetimibe trial ? I forgot what the risk reduction was for that ...15%
If so they may have been willing to reimburse as per a 15% risk reduction ...not the 25% RR that AMRN wants as per the R-IT data .
Everything I read re German reimbursement is the Levels of Evidence rating they use and the need for independent confirming clinical trial data especially randomized Outcome data .
The MITIGATE was IMHO the ideal trial to increase the level of evidence . Right population , independently run by Kaiser and and easy comparison to USA R-IT ....just run it long enough to get to clear divergence of event lines using Total Event analysis ...which I think we agree should be in early / mid 2023.
AMRN has no other RCT Outcome trial on the horizon . If the other major EU countries follow Germany and want more data before reimbursing at a level AMRN can make $ on ...this stock tanks. Maybe they'll follow the UK ....but right now theres no guarantee. I think the risks re reimbursement in the EU were always underplayed . Definitely facing crunch time now . Hopefully Denner can save himself ...and most on this board
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