Amarin Corp Plc (AMRN)

[jomama9231]

try most of these references 24 to 40. I looked through only a few but amrn references those.
the mineral oil issue is a dead issue for multiple reasons
1) the placebo group with higher LDL cholesterol did worse
2) Multiple studies show the rise and even worsening rise in LDL in placebo groups. Thus it is not from the placebo chosen
3) Our 2013 ADCOM had NOT one voter vote against us due to the mineral oil issue. None.
5) ADA provided us standard of care and had no mention of our results being confounded. This will be relied upon heavily at the ADCOM as it makes 0 sense to not provide a label to a drug that is standard of care. That’s a massive problem for physicians and not the goal of an ADCOM. Additionally adcoms cannot force amrn to run a trial (they stated this in their 2013 Adcom) and thus they have to grant the label and if someone later runs a proper trial to put this issue to bed then that’s on them. An option is not label pending a phase 4 trial.

4) Jelis showed 19 percent RRR so we have an outside study providing further scientific evidence our study was not confounded.

It’s a massively one sided argument.


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