Replies to post #275545 on Amarin Corp Plc (AMRN)

[grbnitz4002]

Now would be a good time to for Amarin to bring an action similar to Premarin's against the generics. All generics would be at risk under long standing precedent. Are they the same fish feeding from the same sources...etc

[ziploc_1]

The FDA approved the Marine study for Vascepa's trig lowering effect on LDL in patients with VERY HIGH TRIGS in 2012...then in 2013 the FDA was confronted with Amarin's Anchor request to approve Vascepa for patients with 150 to 500 trigs/dcl...At this period of time, the FDA still didn't believe that Trigs could be lowered without raising LDL in high or...especially very high LDL patients(i.e. the Marine group)...and they felt that increased LDL would lead to more CVD... This is the reason why the FDA refused to approve Vascepa for the Anchor designation...and insisted on the completion of a CVD test(i.e. Reduce-It)to see if Vascepa could lower trig and NOT RAISE LDL, thereby lowering/ not increasing the incidence of CVD....Only AFTER the R-IT test did the FDA become convinced that Vascepa could lower trigs without raising LDL in high as well as very high trigs...

[ziploc_1]

The FDA approved the Marine study for Vascepa's trig lowering effect on LDL in patients with VERY HIGH TRIGS in 2012...then in 2013 the FDA was confronted with Amarin's Anchor request...to approve Vascepa for patients with 150 to 500 trigs/dcl...At this period of time, the FDA still didn't believe that Trigs could be lowered without raising LDL in high or...especially in very high trig patients(i.e. the Marine group)...and they felt that increased LDL would lead to more CVD... This is the reason why the FDA refused to approve Vascepa for the Anchor designation...and insisted on the completion of a CVD test(i.e. the Reduce-It study)to see if Vascepa could lower trigs and NOT RAISE LDL, thereby lowering/not increasing the incidence of CVD....Only AFTER the R-IT test did the FDA become convinced that Vascepa could lower trigs without raising LDL in high trigs in as well as VERY high trigs...

[The Irishman]

Doc, thank you. I am in alignment with your thinking as it relates to the appeal. I think we have a pretty good shot at a win.

I just think back to September of 2018 (think it was September). I woke up, checked my phone and read the news regarding Vascepa’s CV data. The stock shot up premarket. It was a grand day! And then...

With Amarin we must except the fact that we must expect the unexpected. I still like our chances. We are the good guys, we truly are.

Hope you are healing well.

Be well