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Mellowmood77

07/31/19 2:25 PM

#204885 RE: KCSVEN #204871

I think the FDA knows now with 100 percent certainty that EPA is a game changer.

I suspect that they have information in the sNDA not made public in the reduce-it trial. Certain markers that improved with EPA + statin rather than statin alone.

The FDA wants desperately to tackle heart disease. They are desperate for new drugs in the area:

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-takes-steps-spark-development-heart-failure-drugs

IMHO they want as many people on this drug as possible and also IMHO the label will be better than most people here expect.

I believe there will be more people on Vascepa, that aren’t on statins, than people think.





Nukemtiltheyglow

07/31/19 2:33 PM

#204890 RE: KCSVEN #204871

KCSVEN: So, if we're hanging our hats on just the statin population and not considering those not on statins, then it's apples to oranges. The board understands facts or should and shouldn't rely in innuendo. I already provided Population demographics in a post last week.

https://www.nbcnews.com/health/heart-health/too-many-people-stop-their-lifesaving-statins-doctors-say-n789686

An estimated 73 million American adults have high levels of low-density lipoprotein (LDL), or “bad,” cholesterol, according to the Centers for Disease Control and Prevention. Statins such as Lipitor, Mevacor, Crestor and Zocor are among the most widely prescribed drugs in the world and have helped millions of patients avoid heart disease and stroke. In fact, about 28 percent of American men and women over age 40 take a statin, the CDC finds.
Population trends;
https://www.bloomberg.com/news/articles/2019-06-20/half-of-americans-are-now-over-the-age-of-38-census-data-show
Per the attached link, I added up all Americans aged 40 and above and got approximately 155.8 Million. Using the logic above "28 % of Americans over the age of 40 take statins" So, do the math; 155.8 Million x 28% = 43 Million supposedly take statins. I didn't dream this up or produce this out of thin air. These are articles that had some research done.

Now for some conjecture; This tends to fit the sNDA model, correct me if I'm wrong
Question #1 How many Americans should be on statins aged 40 or greater? I know what my cardiologist told me..... I'm 67, my BP was 122, my cholesterol around 200, he prescribed a statin and said I had a 10% chance of having a CVD event in the next 10 years based upon my physical conditions.
Question #2 How many Americans with Cholesterol levels above 135 mg/dl are there?
Question #3 How many Americans percentage wise by age and medical condition say Blood pressure >122 has a history of CVD, typical diet and excercise regimen should be on some form of heart medication?

I can only project what that figure should be and it surely will exceed 43 Million. We're all logical people here, we're obviously all pretty smart and can pick apart any scenario. But really are we to assume that the at risk population is only 12 Million Americans? If you believe that Vascepa market is only 12 Million Americans then god help us.