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Not me for one - I am up to 170,00 shares at $0.20/sh (sold a little Amarin at $20). This is like a cheap lottery ticket with a lot better odds.
Ultraz - If they straight out lied by stating as they did that the halt (to paraphrase) was not necessarily indicating a negative re: trial results, then I do not think the investigation would have taken this long.
In that event, next step (IMO) would be patent infringement suits. Probably did not go that route first because it will be more challenging and expensive (pursue multiple violators). Companies can respond by changing their product to have less EPA (by %), but then they cannot tout it as "pure EPA" anymore.
No - Overall RRR = 25%. Maybe secondary prevention (2/3 of patients) is 27% and diabetic primary prevention (1/3 of patients) is 23%. Numbers are just guesses as an example.
Thank you for stating the obvious!
Stone - My 2 cents. They are testing a different compound than EPA. Even if miraculously effective (right now all they know is it reduces TGs, but we do not know whether TGs are why V is effective), they cannot piggyback on R-It results to get fast approval because it is a different chemical entity and potentially has a different MOA. They will have to raise huge capital and do a R-It type study to get the same indication V will eventually have. Even if approved, remains to be see whether they can compete in terms of price. AMRN has nothing to fear for at least another 8 years or so.
He is hoping he can get his accuracy since 9/24 up to 30%
TTE - Too lazy to come up with event numbers and P values, but I will go on record predicting the following:
Hard Mace (CV death, nonfatal MI, nonfatal stroke): RRR = 29%
Composite of CV death and nonfatal MI: RRR = 31%
Composite of fatal or nonfatal MI: RRR = 31%
Nonelective revascularization: RRR = 25%
CV death: RRR = 30%
Unstable Angina: RRR = 25%
Fatal or nonfatal stroke: RRR = 15%
Composite of total mortality, nonfatal MI, or nonfatal stroke: RRR = 19%
Total Mortality: RRR = 15%
ALSO: Results significant in both primary and secondary prevention groups (RRR > 23% in both)
FWIW - Amarin did NOT announce data lock - only the topline results.
Kiwi - 25% is based on the total enrolled, whether they complied or not (including dropouts if they managed to get follow-up in these). The RRR in the "per protocol" analyses (which I assume they will present at AHA) will be quite a bit higher (>30% most likely). That said, 25% RRR is what MDs will primarily go by as the ITT analysis has less risk of bias.
Princeton - Thanks. I hope my accountant knows that...
HD - You are funny
As posted by someone else, if the Roth has been open for at least 5 years and you are at least 59 1/2 years old, I don't think Roth withdrawals are taxed under any circumstance. I would double check with an accountant though.
To complicate things further, not ALL contributions to a traditional IRA are tax free. If your income level is high enough, they are taxed at the regular rate and then you are taxed again when you do a Roth conversion (but then do not have to pay taxes on gains in the Roth).
North - I have no idea.
Ou - You also cannot get grants for studies that are already ongoing.
TTE = Dr. Suess
You are correct - I do Roth conversions all the time. You are taxed on the value at the time of the conversion.
Actually I do - People are terrible at sticking to desired health behaviors over extended periods.
Agreed it is low. They seem to be increasing their estimates as the earlier price targets are passed, which highlights how conservative they are. Can't do Vegas due to grant reviews, but still considering possible short Chicago trip (but not likely due to kid issues).
Kiwi - I think you are getting the short end of the efficacy vs. cost (to Kaiser) stick. Any reasonable MD would prescribe a low risk drug like V to a person with your risk profile. Key issue is they also have to pay for it, which they don't want to do. Hopefully you win this argument after Nov. 10.
TTE - I pick this one! Actually, it closely parallels the JELIS subgroup results.
North - That $50 target was an incorrect reading of their original poorly worded statement, which got picked up in other outlets (subsequently clarified). CITI was talking about a certain % increase above the pre-9/24 price, and many applied the stated % increase to the much higher PPS when the (dated) report was released.
I think the tiers are set annually (presumably in the fall because they are implemented in January) based in part on negotiations with the companies. This year, my assumption is that AMRN will be showing insurers the R-It data and working to get a better tier. Because insurers are all about making the most money, seems to be common sense that they would prefer that V be used over Lovaza (even if generic). V reduces risk 25% and Lovaza does not - this is proven in recent trials. The RWE studies that AMRN has presented this year also highlight the costs associated with not treating high TGs. Bottom line is the company has a lot of ammunition to argue for preferential tiering.
Insider selling was all preplanned well in advance before they knew what the price would be. It is irrelevant. They sold some cheaply before the readout and sold some expensively afterwards, and accumulated more options.
STS - I think those estimates came from a study that was published in a journal within the past year. They sampled many DS and tested them, and found many instances of adulteration with actual drugs or things not on the label (mostly body building and sex-related supplements, but some others as well). It was not specific to O3s.
Kiwi - I recall evidence that intake of high cholesterol foods (e.g., shrimp) does not necessarily drive blood cholesterol levels. It is more complex than that.
Good find. Rosuvastatin is now generic, so wonder if they plan (as stated in this PR) on seeking approval for this quickly with successful R-it? The study described is the basic design of the study needed to show equivalency, but not sure if this Phase I trial by itself would be sufficient.
Thanks Al - Just give AMRN some time and don't pay much attention to the swings before Nov 10.
Al - Don't worry too much - AMRN is a totally different situation than NWBO. There is no real downside and a lot of upside yet to go.
Raf - Because V is a liquid, the combo pill would end up looking like a V pill (probably same size). I think they would have to do at least an ANCHOR type short term trial to show comparability of combo pill effects on biomarkers relative to taking them separately. Much less expensive a study than R-It. Because R-It has shown statin + V reduce CV risk, I think the FDA would accept the argument that they do not need to do a full scale CV risk reduction study for the combo.
Trevor - I would be careful. The CHERRY study showed a synergistic effect of statins + V (better than either alone) on plaque regression. You cannot assume from R-It that V alone will work as well as the combination.
AVI - Also, JELIS did not show a correlation between TG changes and improved outcomes. They even suggested in print that mechanisms might not be TG related.
Good point
Agreed - From PbChem, it is: "a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol....Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine. It reaches peak plasma concentration in 5 hours post-oral administration. Very little (<1%) is left circulating in the plasma as EPA incorporates into phospholipids, TG's, and cholesteryl esters."
I hope that's the case, but I think one potential argument against this is if there are concerns that there may be race-linked genetic differences that could alter the results. I don't think that R-it had much Asian representation based on the study sites included. Not sure what the intent of and specifics of the new Chinese rules are.
KOLs always refer to prominent scientists and clinicians in the area (usually unaffiliated with the company).
They do sell this OTC and it is a patent violation if the company chooses to prosecute it. There is a pending ITC case that is part of an effort to stop it.
Kev - Back in the 80's I got to go backstage and meet ZZ top (friend was a rep for Gibson guitars). It was surreal. Lots of very tall, very attractive women back there.
Yes - I agree. Plenty of statistical wiggle room.