Replies to post #33630 on Amarin Corp Plc (AMRN)

[sts66]

The only reason someone would be taking Vascepa in this scenario is to reduce the risk for cardiovascular disease. “, “to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease …. Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment”

AMRN said: “DR. KETCHUM: Yes. We factored in existing labels from other lipid-lowering therapies in terms of the types of parameters mentioned in their indication statements and/or in the data tables within the label. So that was the rationale for the proposed indication. Obviously, the application is still under review. We need to dialogue with the FDA team in terms of ultimately arriving at the label. But the hierarchy of the importance is clearly triglycerides without impacting LDL, and non-HDL-C.

FDA says indication (label) is strictly lipids and perhaps secondary endpoints, Ketchum says "Yes" - so how/when did CVE on label, which is R-IT label, get into the equation? Also, why would "not proven to reduce CVE" get a BBW, which is typically reserved for serious adverse effects or contraindications? Why wouldn't it be listed exactly as it is on the MARINE label?

It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis).
It is not known if VASCEPA prevents you from having a heart attack or stroke.
It is not known if VASCEPA is safe and effective in children.

[ladavis23]

HD-

Well said. I do agree with much of what you say. I just happen to believe that these is one of the most incompetent management teams I have personally ever seen. And yes, managements can make all the difference with a company.

Taking $3.75 b ($20 a share x $5.35 all in at the time) having not to worry about NCE, having not to worry about Anchor, having not to worry about hiring a SF, having not to worry about R-It, the FDA, etc etc was a MISTAKE, considering the company was not fully prepared to GIA. They were in over their heads. Almost every action, and comment, since GIA announced has been shaky and has shown lack of experience. The problem I have is that these same characters are still making decisions. For all we know JT is a puppet, and JZ is still running the show as a board member. The fact that he is still there really is sickening, and I believe it keeps a cloud over the company until the day he leaves for good. But thats just me...Also, if the FDA does not reinstate the SPA, that tells me that they are more than confident in their defense if AMRN comes after them. Where would that confidence come from if it "appears" so overwhelming that AMRN has "right on their side?" I believe they have details that would shed some light on their dealings and conversations with AMRN that would be made public that they feel very comfortable with releasing. Again, thats just me.