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HD, are you implying that the Baker Brothers will have another 50 bagger?
HD, thanks for the detailed calculation. Just make sure I understand,
Jelis control arm's EPA/AA ratio = .63, produced a MACE event rate of 2.2% in the high risk group
R-IT Vascepa arm's EPA/AA ratio should be at least .56, MACE event rate should be less than 4% and close to 2.2% if the EPA/AA ratio is around .63
Is my interpretation of your calculation correct? TIA.
I agree with the patent lawsuits. However, NCE is all upside from here. Currently, Vascepa is not a NCE which is the market expectation. Judge Moss's upcoming decision could change this. Same thing for ANCHOR indication. Amarin has already got the CRL. The bad news have already been priced in. However, a 1st amendment win could change market perception, hence the upside potential. To sum up, the NCE and 1st amendment lawsuits are just no brainer attempts for a brighter future for Amarin.
AK, for the stock to be cut in half, the market expectation has to be "trial will be stopped at interim". If the market expectation is "trial will be stopped at interim", the stock should be traded at multiple times of its current value, i.e., 50% probability of a potential $5B/yr drug. We'll all be rich right before RI interim readout at the beginning of 2016. You'll have to make a decision whether to take your profit at that time.
In short, if AK's theory is right, "stock to be cut in half", you should see a significant run up for the stock as we approach interim readout.
Thanks HD.
Zetia annual sales is over $2B. That's for a drug that reduces annual MACE event by 6% in combination with statins. RI will be a home run, IMO, but don't have to be. Even a 15% MACE reduction will translate into a billion dollar drug. So what if we have to wait extra 2 years for final RI readout if no interim stop. Amarin has 2 years worth of cash runway, growing sales, improved margin and rich backer such as the Baker Brothers. China money will start to roll in 2018/2019. They also have other strategic levers to pull if they need to. The day of worrying about Amarin survival is over.
Right now the market has priced in the worst case, i.e., Vascepa not a NCE, no ANCHOR approval, RI readout till 2018, etc. What happen if we get a +ve ruling from Judge Moss, a win in the 1st amendment suit, +ve 2016 RI interim result. I would think the upside is many times greater than the downside. That's what I call asymmetrical returns, something i try to look for everyday in the stock market.
HD, staying up so late is not good for one's liver. Just a friendly advice. I want you to live long and healthy in order to enjoy your Amarin payoff.
Thanks JL. I got you. I am just thinking that the RI control arm patients are so much sicker than their Japanese counterpart that their AA levels are probably way out of whack. Hence looking for a 2.2% event rate for the RI control arm might be a bit aggressive, but I am not going to argue with the great JL and Dr. Sears. Their knowledge and experience are far greater than mine.
JL, 4g EPA/day raises the plasma EPA level of RI Vascepa arm to Jelis Epadel arm level, according to Amarin management. Hence, the EPA/AA ratio of RI Vascepa arm must be less than the EPA/AA ratio of the Jelis Epadel arm. If the main driver of the MACE event rate is the EPA/AA ratio, then the RI Vascepa arm event rate should be greater than 2.2%. I am hoping it's less than 4%.
BC, so what's more important for CV health, high absolute plasma EPA level or high EPA/AA ratio? The reason I ask is that you could have a very high and healthy plasma EPA level and still have a lousy EPA/AA ratio if the AA is way out of whack like in those of the sickest R-I patients whose event rate might be higher than the 2.2% that JL referenced in the JELIS cohort.
BC, you are our resident expert here on the importance of EPA/AA ratio. Do you have any comments regarding the differnce in EPA/AA ratios between the RI Vascepa arm Vs JELIS Epadel arm? TIA.
Strong pre-market action with no news for our Amarin Corp., a rare occurrence.
JL or HD, according to Amarin, the plasma EPA level for Jelis Epadel arm and RI Vascepa arm are similar. It seems logical to assume AA levels for RI patients to be higher than that of JELIS patients, hence I think the EPA/AA ratio to be lower in RI Vascepa arm than Jelis Epadel arm. Do you agree?
Clientele is those who's taking statins which is a huge growing market.
According to Amarin, the additional 2.2g EPA/day does bring the EPA level of the R-I Vascepa arm to similar level of those in the JELIS Vascepa arm, see p.8 of the following link provided by Zum earlier:
"despite the differences in EPA baseline levels, dose and duration of treatment between JELIS (1.8 g/day in a Japanese population for a median follow up of 4.6 years) and the ANCHOR study (4 g/day
in a more diverse and Westernize population for 12 weeks), the final plasma EPA levels were similar between studies"
http://files.shareholder.com/downloads/AMRN/2797408146x0x827821/1a34f63e-96ed-4efe-abe6-622c1e761b7c/3_FAQ_High_TG_2015_05_07.pdf
So we have the numerator of the EPA/AA ratio being similar but the denominator still a mystery between the 2 groups, Jelis and R-I.
JL, thanks for the clear explanation. I hope the additional 2.2g of pure EPA can bring the R-I Vascepa arm back close to the 1/2.5 ratio, i.e., R-I patients were not too sick to be helped by Vascepa therapy. I would hope even a 1/4 EPA/AA ratio could translate to greater than 20% efficacy. Thanks again for your insights.
NCE exclusivity really means 8-yr exclusivity until generic competition at the earliest. So it's a big F'ing deal, third importance only after Vascepa patents strength and REDUCE-IT success. The market value gained with Vascepa NCE status is tremendous and can be quantified.
*****
NCE exclusivity is explained in the FDC Act vis-à-vis the submission and approval of an ANDA (at FDC Act § 505(j)(5)(F)(ii)) or a 505(b)(2) application (at FDC Act § 505(c)(3)(E)(ii)) for a drug product containing an active moiety protected by NCE exclusivity. For example, FDC Act § 505(j)(5)(F)(ii) states:
If an application submitted under [FDC Act § 505(b)] for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under [FDC Act § 505(b)], is approved after September 24, 1984, no [ANDA] may be submitted under [FDC Act § 505(j)] which refers to the drug for which the [FDC Act § 505(b)] application was submitted before the expiration of five years from the date of the approval of the application under [FDC Act § 505(b)], except that [an ANDA] may be submitted under [FDC Act § 505(j)] after the expiration of four years from the date of the approval of the [FDC Act § 505(b)] application if it contains a [Paragraph IV certification]. The approval of such [ANDA] shall be made effective in accordance with [FDC Act § 505(j)(5)(B)] except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the [NCE NDA], the thirty-month period referred to in [FDC Act § 505(j)(5)(B)(iii)] shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the [NCE NDA].
****
You also get additional 6 months of pediatric exclusivity.
You have to focus on what can affect price per share, not the price itself. The downside is limited (price wise), the upside take care of itself. Always look for asymmetrical risk opportunities.
Jackie Chan calls America 'most corrupt country in the world'
http://www.dailymail.co.uk/news/article-2261567/Jackie-Chan-calls-America-corrupt-country-world.html
I won't categorized Judge Moss's NCE ruling as "delayed decision" as there is no benchmark for similar ruling. I believe the Depomed case, which is a more black and white IMO, take a while too.
I am confident that Amarin will not make the same mistake as OREX,
http://www.forbes.com/sites/matthewherper/2015/05/12/a-top-cardiologist-says-a-diet-drug-maker-misled-patients-and-investors/
Or try this link, put in the date for 5/15/15 thru 5/29/15,
http://www.dcd.uscourts.gov/dcd/court-calendars
Judge Moss is quite busy according to the following schedule,
https://ecf.dcd.uscourts.gov/cgi-bin/CourtSched.pl
AP, I know "LDL-C being a valid surrogate biomarker" as far as FDA is concerned. Do we at least agree that FDA's not 100% right on all its scientific reasoning? Are there any double blind placebo controlled CVOT trials that proved LDL-C is indeed a valid biomarkers? You can save me some time by giving me the names of those trials. Otherwise, I'll look up ESPR's slide deck.
IMO, its reckless to approve PCSK9 without CVOT unless for extreme cases because of unknown benefits (are we sure it's beneficial to cut LDL-C level from 100 to 50 and cause no harm)and side effects.
You might say it's reckless to approve Vascepa for ANCHOR indiction, but at least Vascepa has placebo like side effect and it has an ongoing CVOT trial that's near completion.
JL, thanks for teaching me a new phrase, "hoisted on its own petard". Couldn't agree more with you. Always learn something from reading your and HD's posts.
***
p.s. I looked up the meaning of petard:
A petard was a small bomb used to blow up gates and walls when breaching fortifications. It is of French origin and dates back to the sixteenth century. A typical petard was a conical or rectangular metal object containing 2–3 kg (5 or 6 pounds) of gunpowder, with a slow match as a fuse.
Anybody has issue on communicating with "truthful and non misleading statements" in our society or our universe? Please let me know.
AK, I disagree. "the court would be swamped with challenges from other drug companies wanting the same". Do you see any evidence of such since the 2012 1st amendment lawsuit triumph? Are you aware of any successful phase 3 trial with overwhelming efficacy that's not allowed to be marketed?
AP, what's the name of those CVOTs or just old wives tales spread by BPs with the support of previous FDA regime?
If that's the best you can come up with ... I guess I have to do more digging myself. Thanks anyway.
Zip, I disagree.
You said it, " relentless arbitrary and capricious treatment of the company". If R-I is wildly successful, FDA can still drag its feet to screw Amarin. On the other hand, a first amendment win makes FDA irrelevant.
AK, since you are the statin expert here, do you know of any double blind placebo controlled outcome trial for Zocor, Liptior or Crestor to see if LDL-C is a valid bio-marker for CVD. I don’t consider Jupiter a LDL-C trial, it’s more like a hsCRP trial. The reason I ask is that the late Eric Colman once said PCSK9 drug might not need an outcome trial because it lowers LDL-C. Just give me the names of those trials and I’ll google them. TIA.
NCE decision, overseas rights transactions, improved scripts due to Lovaza switch over, run up to interim results, etc. Too many to list, really.
Amarin is not an earning story like Apple. As long as script growth is in an uptrend and not falling behind other lipid lowering drugs, shareholders should take a longer term view. Most important for Amarin is patents, R-I success and NCE in that order.
Sales are booked based on drugs sent to wholesalers, not scripts dispensed from pharmacy. Long term, they should match but does vary from Q to Q depends on inventory level.
Totally agree. I want JT to be my CEO and BB (Bakers Brothers) & BB (biotech_billionaire) to be his strategic advisors any day.
It's all making sense now. Dropping SPA appeal accelerate CRL, allowing 1st amendment lawsuit to filed shortly after. Hopefully lawsuit outcome coincide with successful R-I interim, then FDA's hatred towards Amarin won't matter much anymore.
Amarin seems to have a strong case,
"The filing also makes several points in Amarin’s favor: that fish-oil-containing dietary supplements can make a claim that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease;” also that other drugs to lower triglycerides, like niacin and TriCor, both sold by AbbVie ABBV +1.19%, and the fish oil pill Lovaza, made by GlaxoSmithKline , are allowed to be marketed to a broader swath of people with high triglycerides."
http://www.forbes.com/sites/matthewherper/2015/05/07/prescription-fish-oil-maker-hires-top-lawyer-to-sue-fda-on-first-amendment-grounds/
Zip, I was hoping people view the FDA lawsuit as -ve and try to pick up some cheap shares. I am going to bid 20K at 1.99 now.
I am buying 20000 shares @ 1.9 now.
BC, thanks. That's a positive development. I think I own too many AMRN shares. My heart beat double after learning the trading halt.