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Monday, 11/12/2018 7:32:32 AM

Monday, November 12, 2018 7:32:32 AM

Post# of 425976
A few observations...

The supposed elephant in the room - the placebo.

In the placebo arm of the trial the baseline LDL-C was 76, and after nearly 5 years it rose to 84, which amounts to a median absolute change of 7 points according to the NEJM publication. This is a tiny increase after nearly 5 years and at 84 the LDL-C value is still well within the American Heart Association's recommended guidelines which were released on Saturday:

"While there is no ideal target blood level for LDL-C, the 2018
guideline recognizes, in principle, that “lower is better.” Studies
suggest that an optimal total cholesterol level is about 150 mg/dL,
with LDL-C at or below 100 mg/dL, and adults with LDL-C in this level
have lower rates of heart disease and stroke."

https://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_502959.pdf

Seems to me that the case for mineral oil effecting statin absorption is completely unfounded. You couldn't possibly have LDL-C as low as 84 in a patient population as sick as this after nearly 5 years without the statin working very very well. The LDL-C placebo criticism is a non-issue.

The next criticism was the hs-CRP value. This marker basically measures inflammation and it is thought that a high level of hs-CRP is associated with an increased risk of heart attacks. Ideally you want a hs-CRP value <2.0 :

"Lower risk. You have an hs-CRP level of less than 2.0 milligram per liter (mg/L).

Higher risk. You have an hs-CRP level greater than 2.0 mg/L."

https://www.mayoclinic.org/tests-procedures/c-reactive-protein-test/about/pac-20385228

For the Vascepa arm at baseline you had 2.2, and in the placebo arm it was 2.1. This difference of 0.1 amounts to patients in the Vascepa arm starting out with a near 5% greater risk than the patients in the placebo arm. After the near 5 years the hs-CRP levels dropped to 1.8 in the Vascepa arm which puts the patients in the 'lower-risk' category. This in itself is a very impressive result regardless of how it fared compared to placebo.

The placebo arm saw their hs-CRP levels rise from 2.1 to 2.8. To attribute this increase in inflammation directly to the placebo alone is ridiculous. There are innumerable factors which could have contributed to patients increased levels of inflammation including the consumption of alcohol, refined oils high in omega-6, refined sugar, red meat and processed meat consumption, dairy etc etc. To pin a 0.7 point increase in an already highly inflammed patient population all on the placebo is completely disingenuous. These patients were already in the 'higher risk' category to begin with so it's no surprise to see them remaining there without the aid of Vascepa which clearly has powerful anti-inflammatory properties. And when you consider that the patient population in the Vascepa arm will have also have had a high consumption of pro-inflammatory foods in their diet it makes the reduction all the more impressive.

The results from this REDUCE-IT trial are spectacular, simple as that. The supposed elephant in the room far more closely resembles a mouse on closer inspection - not even a mouse - a speck of dust at most.

Regarding today's share price action, I expect there to be a bear raid on the back of the hit-piece articles. The goal will be to drive the share price down so the shorts have a chance to cover. Any remaining weak longs will also be shaken out of their holdings as panic mode sets in. They will drive it well under $20 on high volume.

All just my opinion as a long-time retail shareholder. Take it or leave it.





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