Amarin Corp Plc (AMRN)

[HDGabor]

r- (& all)

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First of all, to all: It is funny to read post - challenging r- real identity - by unidentified nickname / user. It is - at least - off-topic (and were Personal Attack several times. If you have a different / opposite view, write it objectively
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If the drug were a booming success study probably would have already been stopped. That leaves us with the ff possibilities:

1.) Moderate success in general population ( best choice)

It suggest, that you are not aware of the stopping boundary type ... did not understand it. The PE alone weren't a trigger for stop or continuation, it was a gatekeeper for analysis of SEs. 30%+ RRR for PE - which is a booming success ... I think we agree on it - does not mean that all required SEs were robust and consistent, but more importantly does not mean that robust and consistent, but isn't stat. sign SE(s) could not be stat. sign. - which is a booming success ... I think we agree on it - at final, in case of continuation.

last hurdle is that about 60- 70% of my Rx's for vascepa get returned from the insurance company indicating that the patient should use OTC omega 3.

I do not challenge your personal experience, I take it as a fact, BUT it is your personal experience.
- personal experience is false usually (w/o general experience). You could be right, but it is a luck only. We have one other fun of personal experiences ... based on his experience cheap co-pay and V card aren't available ... does it mean that cheap co-pay and V card aren't exist? ... Of course: not.
- V was covered by 200+M year(s) ago, T2 is more than 140M now
- The prescription O3 market more or less flat since the launch of V, wasn't affected by patient should use OTC omega 3

The totality of the available info does not support your personal experience ... it is not equal with the (real) world.

FDA supposition that trigs in the 200- 500 mg/dl range need not be treated ... almost definitive link between high triglycerides and extremely high risk of heart attacks (study showed 40pct reduction in heart attacks for those w normal triglycerides versus high levels.) This clearly reveals the need to treat triglyceride elevations ... JELIS study involving 18,000 individuals in Japan that showed almost a 50% reduction on coronary events for individuals already taking statin to which EPA (Vascepa) was added ... Vascepa does not lower trigs very well - actually its rather dismal and insurance coverage is ridiculous and if OTC provides the same benefit - why not use it

- FDA did not say "that trigs in the 200- 500 mg/dl range need not be treated" ... at least I am not aware of it. They said: TG lowering does not mean necessarily that CVE risk will be reduced, the science is mixed, proof is necessary
- I am not aware of any study that did not show significant TG reduction by V ... so it looks like it is your personal experience only (see above) ... furthermore it is about TG only:
> NEJM study is one study only ... and confirms that high TG among high risk patients is more common than among low risk patients, but did not confirm that reducing TG will be resulted in lower risk ... and nobody would like to reduced TG just for "fun".
> Meanwhile I try to avoid to post any medical / scientific opinion, I "have to" now ... I see high TG as a symptom, but not as a cause (of CVE). Studies with impressive decreases in TG levels (ORIGIN and R&P trial) did not decrease CVE, meanwhile studies with dismal decreases of TG, decreased the CVE significantly (GISSI-P: -3.4% TG & -20% CVE, JELIS: -5.0% TG & -19% CVE)

Best,
G

ps.: It was interesting to see, you used JELIS as a proof (in your letter), but forgot the details of it in case of TG reduction ...