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Re: None

Friday, 06/27/2014 5:29:36 PM

Friday, June 27, 2014 5:29:36 PM

Post# of 426505
Keep calm and be gentleman. It’s useless to insult each other and rake over the ashes of the past.

Yes, the management could do a lot of things in a different way, however I do not see any big mistake (or we could not measure it yet, ie.: Senior Note conversion).

A lot of people said that GIA was a wrong decision. Yes, it’s right, however ask yourself: if I have a product which is approved and it will be approved for a larger population within a year, should I sell it now or later?

We have to focus on the future and analyze that. So what’s happened since rescission?

- Amarin reached the originally targeted level, the first level which was not involved in the AdCom and the rescission and will check all aspect of the issue (I could not find it, but as I remember Thero said that this is the first level which will take into consideration more than the science)
- a recent pair of studies in the New England Journal of Medicine identify gene mutations that lower both triglycerides and heart disease risk, suggesting that drugs that target that gene pathway could be beneficial
- new paper in Atherosclerosis, coauthored by Emory’s Terry Jacobson, looks at LDL-P, a different way of looking at LDL that has been proposed to be a better measure of cardiovascular disease risk
- U.S. House of Representatives / U.S. Senate Committee on Appropriations dealing with the SPA rescission in the accompanying report and requested several action / answer from FDA

I think these are a good / positive thing and I do not know any negative.
Is it enough?
I do not know. Maybe Jenkins also does not know yet.
We will know it app. within 45 days.
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