IMHO insurance co's will resist paying for the PCSK9's except for those hetero FH patients who are statin intolerant . Hetero FH are LDL levels 180-500 , about 10-20% are Statin intolerant .
In this patient population 85% have a CV event by age 65 .
So there are about 800,000 people in the US with hetero FH ...probably half are undiagnosed . So assume
400,000 prescribed high dose Statin drugs ....of which 40,000 to 80,000 are Statin intolerant .
Thats the initial target market for PCSK9's
Vascepa is for an almost completely different patient population , there may be some over lap ..but most benefit will be seen with diabetics and mixed dyslipidemia patients . Hetero FH patients will benefit from adding Vascepa as EPA is known to reduce coronary arterial plaque rupture ....and all hetero FH patients have coronary arterial plaques by age 40.
The company has a product, Vascepa, lowering TG and possibly lowering CHD risks. The company was hijacked by FDA's SPA and too late to escape the "show me" recession.
The current SCRIPT level Is just so-so but not too bad with regard of MARINE. By any official standard, the core ANCHOR (lowering TG in 200-499 population) should be approved w/o those "CHD" wordings (belongs to R-I). I expect to see a CRL on ANCHOR sNDA or an approve with a Class I. Just my understanding. Comments are welcome.
Amarin could get an upgrade soon
perhaps you could use your resources to go after the FDA...after all, their false claims have cost me 5 figures!
I have no guts and talents to do day-trading or short-term turnover. I like observe the market trying to understand then make a long-term move.
Daily (and short-term) trading is well controlled by HFs or institutions.
For AMRN, the hardest is the timing. The focus is seemingly on whether the company has enough fund to reach R-I interim. But, I don't be bothered too much about that. My take: the company is capable to do it with Vascepa's performances (safety and lowering TG) and potentials (lowering CHD risks). A lot of weights are on "potentials". Institutions clearly understand (e.g., recent 9M shares buy).
Scientifically, the "potentials" has grounds, but real stuffs should be seen above the grounds to secure the "potentials."
Currently, we are likely in a "Casino." Without clear timings, bet late mat cost a lot, but big boys make early-birds shacking -- the earth is a round one, anyway. ......
maybe they are buying more now.
I see first post with the new id shorty. Not going to work and welcome to iggy land.
Sentiment: Strong Buy
Amarin Announces Presentation of MARINE and ANCHOR Analyses at the American Heart Association Scientific Sessions Showing Vascepa(R) Significantly Reduced Remnant-Like Particle Cholesterol in Hypertriglyceridemic Patients
You, at least, have a clue about health care reimbursement. These other dimwits hear about the next great thing (and don't get me wrong PCSK9 inhibitors are a cool drug development program) and think payers are going to line up to fork out for a prescription that is an order of magnitude+ more expensive than current standard of care.
I'm not even sure that patients will USE an injectable for a chronic disease that is not an immediate morbidity threat at all. But the marketing machines of pharma are pretty good so I can't rule it out.
One other thing though, PCSK9 inhibitors deal with lowering cholesterol by increasing LDL-C metabolism and the MOA for Vascepa is likely a combination of lowering the availability of the buliding blocks of atherosclerosis (high trigs and to a smaller extant cholesterol), while also lowering the glue that allows plaques to form (anti-inflammatory effects). They are two completely different MOAs, so do PCSK9s really have anything to do with Vascepa's market? Does not seem so to me but perhaps I am missing something.....
9 million is some serious buying