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amarinbullfromchicago

11/09/19 5:11 PM

#223936 RE: Atom0aks #223934

This is probably the most narrow recommended label by a health org, and this population will still lead to 10b a year in revs in the US alone. So doesn’t really seem like a negative, just a worst case scenario (10b US sales a year assuming all other trials do poorly, which is unlikely).

So maybe stock only gets to $100. I’ll live

Mr1979

11/09/19 5:12 PM

#223937 RE: Atom0aks #223934

That is many millions of patients is it not ? Do we have an idea of how many that is? There are 30 million diabetics in US and 40 million people on statins I think. No clue how this will play out but I do know that it’s all about the new patient population in terms of a new valuation for the company

Whalatane

11/09/19 5:16 PM

#223938 RE: Atom0aks #223934

Atom ..its not an either / or question IMHO
ie Not ASCVD or diabetes with 1 additional risk factor

*—Clinical ASCVD includes acute coronary syndromes, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.Aug 15, 2014


Diabetics with one additional risk factor may have never had any of the above ...MI, Stroke etc ......but will be included in the label.

90% of those with diabetes have 1 additional risk factor ...often high blood pressure

So you combine those 2 groups Clinical ASCVD and diabetics with 1 additional risk factor ....all on some statin and all with TG's over 135 mg/dl ....that is a huge population .

If you are thinking the final Adcom vote will be wether to approve for primary prevention .....I wouldn't bet on that . Would be fantastic but IMHO unlikely .
It makes perfect sense to include primary prevention ...ie all on statins add Vascepa ...why wait for the ASCVD qualifying event ...BUT the basic ASCVD plus diabetic label is not a failure ...its still a huge population

Theres an ASCVD risk scale in primary prevention and those MD's that use that are IMHO are going to prescribe if you have elevated risk even if you aren't clinically ASCVD .

Note .." 80% of people with Type 2 diabetes have high blood pressure."...from a diabetes site ...theres you 1 additional risk factor ...the other 10 % is another type of risk factor
JMO
Kiwi

Mellowmood77

11/09/19 5:18 PM

#223939 RE: Atom0aks #223934

87% of people with Diabetes have an additional risk factor.

Whalatane

11/09/19 5:52 PM

#223941 RE: Atom0aks #223934

Atom. To clarify my earlier post

I think the voting question will be something like
Should the label cover all those with clinical ASCVD and all those diagnosed with diabetes plus one additional risk factor .... all of whom are on statin therapy with TG’s over 135 mg / dL .

The answer imho will be a unanimous yes vote .

Kiwi