Replies to post #24842 on Amarin Corp Plc (AMRN)

[nutsyprofessor]

"YET they did approve Vascepa for treating Acute Pancreatitus YET that was not Amarins reason for selling Vascepa!"

But again, that's because everyone in the scientific community knows and understands that Very High TG's >1000 mg/dl, is a serious health concern that needs to be addressed and corrective action for TG's in that range is by taking drugs, according to both NCEP and VA.

The problem with TG's in the 200-499 range is that there is no agreement in the scientific community that this level represents a serious health concern, or at least, a definite tie to a serious health concern.

As an example of this disagreement in the scientific community, look at the NCEP/VA treatment guidelines given for a TG 200-499 level (see tables on pg 12 of the link provided below) and you will understand why the FDA is not motivated to approve any Omega 3 type product for TG's in the 200-499 mg/dl level:

http://www.utexas.edu/pharmacy/divisions/pharmaco/rounds/ramirez09-13-2013.pdf

[no_mo_Butterfinger]

JohnKing, The smarter thing would have been to simply go for the already proven results from the ANCHOR trial, lowering trigs and get the approval. Then after the R-IT results they could ask for an amended label for what they could again, actually prove, rather than just claim, that lowering trigs reduces CVE's.
Hindsight I know, but I think this is what most of us thought was the direction they were going to take and the reason we were all in shock with the CVE angle at the adcom

And thank you for all your informative posts. They are most appreciated.