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Nice to see the ACC continuing to recognize R-IT. The authors are all with Johns Hopkins Medicine and have no ties with Amarin. Johns Hopkins hospital is ranked #3 in the U.S and "is the nation’s top-ranked hospital combined for both adult and pediatric care" according to the website.
No mention of any concerns with the placebo again. Seems to be mainly a Pyrhonnian/Nissen and his associates/Forbes and Herper kind of a thing.
I'll take the qualified opinions of the ACC and Johns Hopkins any day over any opinions that Matt Herper and Dr. Nissen and his associates have to offer.
I wonder do AZN, Herper, and Nissen think little ol' Amarin are a soft touch and easy prey? Lets see about that.
It's not gone yet.
Yesterday's close was 16.83. The low so far today is 16.85. So there's still a gap below. That gap adds to the gap above between 18.13 and 19.39.
If I had to guess i'd say the gap in the 16's gets filled first and they may continue walking it down to the $15's. Strong support in the $15's though so I don't personally see it going much lower than that if it does keep trending down. Then it's back up to fill the gap between 18.13 and 19.39 IMO.
Also looks to me like the S&P is making a fake up move and will head back down shortly. It still has gaps of its own to fill below.
Here's Judge Engelmayer's FDA vs Amarin 'opinion and order' for anyone interested. Covers the whole labeling and promoting thing and goes into the CRL also:
http://www.fdalawblog.net/wp-content/uploads/archives/docs/Amarin%20Decision%208-2015%20Off-Label.pdf
"The FDA added: “Given the
current level of uncertainty regarding the benefits of drug-induced changes in lipid/lipoprotein
parameters on [cardiovascular] risk among statin-treated patients with residually high
[triglycerides], you will need to provide evidence that Vascepa reduces the risk of major adverse
[cardiovascular] events in patients at high risk for cardiovascular disease . . . . We anticipate that
the final results from the REDUCE-IT trial could be submitted to satisfy this deficiency.” Id. at
2. Accordingly, the FDA stated, before it would approve Vascepa for use in patients with
persistently high triglycerides, Amarin would need to supply evidence, such as from the ongoing
REDUCE-IT study, that the drug reduces the risk of cardiovascular events. Id."
Page 25
"On May 7, 2015, 10 days after receiving the CRL, Amarin and the doctor plaintiffs filed
the Complaint. Dkt. 1 (“Compl.”). It brought an as-applied First Amendment challenge to FDA
regulations that prohibit Amarin “from making completely truthful and non-misleading
statements about its product to sophisticated healthcare professionals,” including the doctor
plaintiffs. Compl. ¶ 1.
Specifically, the Complaint alleged that Amarin wishes to make truthful statements to
healthcare professionals (hereinafter, “doctors”) regarding Vascepa, including that the ANCHOR
study demonstrates that Vascepa significantly reduces triglyceride levels in patients with
persistently high triglyceride levels. But, it alleged, Amarin is inhibited from doing so by the
FDA’s threat, articulated in the CRL, to bring a misbranding action based on such off-label
promotion."
Page 26
This may be of use to you:
https://www.sec.gov/Archives/edgar/data/897448/000119312515150702/d916310d8k.htm
"In prior dialogue with Amarin, FDA urged Amarin to complete the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial) cardiovascular outcomes study. Consistent with this position, FDA stated to Amarin in the CRL that FDA anticipates that the final results from the REDUCE-IT trial could be submitted to satisfy the FDA’s uncertainty regarding the benefits of drug-induced changes in lipid/lipoprotein parameters on cardiovascular risk in the ANCHOR population. The CRL has no effect on the SPA agreement for the REDUCE-IT study or the anticipated timing for results from the REDUCE-IT study."
I'll see if I can dig up the actual CRL letter....
Thanks. I've been burned with those gaps too many times before so i've had to learn the hard way to respect them. In fairness my prediction was correct but my timing was way off. I thought they would take it up to $23 first and didn't expect the gap to be filled until Jan-Feb:
"Should bounce off the resistance around $23 and start trending back down towards slowly $14 after that. Too much volume down there at $14-15 for them not to re-test that area and pick up more cheap shares. Still a gap in the low $16's between 16.28 and 16.12 that needs to be filled also. I'm thinking by the end of January and February."
And:
"...i'm still very wary of that gap between 16.12 - 16.28. The story obviously unfolds day by day, week by week, and month by month so still too early to tell what will happen in January yet, but with what i currently see im thinking that its taken down to fill that gap and then even further down to the $15s and maybe even briefly to the $14s."
A low today of 16.12 so it's filled now.
I'm also way off with this weeks prediction but the week is still early so plenty of time for a turnaround:
"I'm looking for a close at or above 20.83 next week for the end of the month. That would be a very bullish signal for me with this stock for 2019. I'm looking for a close above 23.34 end of year then."
Completey agreed. What significance do you place on today's Evercore conference considering who they are and what they do?
"Evercore's Investment Banking business advises its clients on mergers and acquisitions, divestitures, restructurings, financings, public offerings, private placements and other strategic transactions and also provides institutional investors with macro and fundamental equity research, sales and trading execution. Evercore's Investment Management business comprises wealth management, institutional asset management and private equity investing. Evercore serves clients from 28 offices in North America, Europe, South America and Asia.[4] Since 1995, the firm has advised on more than $3 trillion of merger, acquisition, recapitalization, and restructuring transactions. In the 2018 Vault Banking 50, Evercore was ranked as the #2 investment bank in the world, behind Goldman Sachs."
https://en.wikipedia.org/wiki/Evercore
"IMO Forbes created an actionable false market for shorts"
Well, considering the overall tone of the article and it's lack of balance, it would be hard to argue against that.
Completely agree that the embargo rule is a joke. I understand embargo's make sense for situations like sporting events and what have you, but no way in hell they should ever apply to events like major scientific publications of trial data - the interpretation of which can potentially have a major impact on a companies share price - and considering the slant that a journalist in a prominent publication takes in their article (and one devoid of any detailed disclosures).
Who is Herper anyway? A journalist with an opinion reporting opinions. And who is Nissen? A scientist with an opinion and a major conflict of interest. So who's responsibility is it to police opinions and prevent journalists like Herper and scientists like Nissen from saying whatever they want no matter how ridiculous their opinions are? I have no idea. Yours? The SEC's? The FDA's? And why do we have to wait months on end before the FDA says anything about the matter, leaving the whole thing in limbo until an ADCOM? It's a complete farce.
"...FORBES article created a “false market” for short activity..."
I hear what you are saying but can't say that I completely agree. My take is that Nissen and the other doctors with ties to Nissen are the main culprits here. Herper and Forbes will argue that they just published an article voicing the concerns of these cardiologists. The cardiologists will then argue that their concerns were legitimate because the FDA themselves have raised issue with the mineral oil before. So you can't win.
What Forbes are guilty of is providing a platform for these cardiologists to voice their negativity IMO - i think the article had 4 cardiologist quotes with a negative tone (3 with ties to AZN and/or Nissen), 1 neutral, and 2 positive (with ties to Amarin). How is that good/balanced journalism with all those conflicts of interests going on? Good and balanced journalism is what he did in his article afterwards where he cited the opinion of prominent cardiologists from Oxford and Harvard etc with no ties to either Amarin, Nissen or AZN.
IMO nothing will stop these media outlets publishing bearish articles because there is always a bear case to be argued for, but at the very least every article should have a disclosure section under each article highlighting the conflicts of interest of the individuals quoted. Why should I have to go to the trouble of having to research every doctor/cardiologist that is quoted to find out if they might have a hidden agenda/biased opinion? That should be the authors job. The way it is now is pure cloak and dagger.
3% dilution and 200M cash. Sounds good to me. With around 80M cash already on their books, and another potential/likely 30M from this offering, Amarin will have over $300M cash and no major current clinical trial expenses. Gives them far more wiggle room than 80M did.
Some of the cash could be used to clean up the balance sheet and remove any debt and they will still have plenty left over for marketing and promoting Vascepa and R-IT -> increased revenue.
What's not to like?
You may also recall that Mr Feuerstein correctly predicted this dilution several weeks ago.
His comment on this dilution on Twitter:
"Yup… Took longer than I expected."
What did he say about a BO and Amgen again?
"...you do not have a good understanding of the FDA..."
My understanding of the FDA and how they operate is exactly where it needs to be.
At the ADCOM the FDA will ask the panel of experts 2 questions. The first question will pertain to safety. The second question will pertain to substantial evidence of efficacy. Federal regulations require the FDA to ask these questions.
The answer to both question is very obvious IMO.
To FDA follows the advisory panel's verdicts about 3/4's of the time:
https://www.forbes.com/sites/matthewherper/2010/10/12/the-fda-ignores-its-advisors-a-quarter-of-the-time/#2941fa143b97
"FDA is plenty concerned already."
I don't see it. IMO you are focusing on the teeny tiniest shred of negativity that you can find and you are blowing it way out of proportion. You even admitted yourself as an uber contrarian that Vascepa likely showed a 15% RRR, even after all your extensive digging and attempts to find flaws. You think the FDA are going to ignore a 25% RRR (or even a 15% RRR) and deny patients access to a drug that has clear benefits and very little in the way of safety concerns relative to anything else currently approved and on the market?
There is a boatload of info clearly showing EPA's anti-inflammatory effects and positive influence on EPA serum levels irrespective of whatever the placebo arm data shows, and at the end of the day patients will be taking 4g of EPA if approved - NOT 4g of mineral oil. So your points are mute for me.
"No strong evidence for biological activity of the same mineral oil was identified in connection with FDA approval of VASCEPA in July 2012 based on the MARINE phase 3 clinical trial, in connection with FDA review of the ANCHOR phase 3 clinical trial, or after several years of quarterly review by the Data Monitoring Committee (DMC) for REDUCE-IT after FDA requested that the DMC periodically assess unblinded lipid data to monitor for signals that the placebo might not be inert. While the DMC noted variation in LDL-C measurements in both arms and that a small physiological effect of mineral oil might be possible, the DMC concluded that it was not possible to determine if the LDL-C increase in the placebo arm was a natural increase over time or due to the mineral oil, they found no apparent effect on outcomes and found that this small change was unlikely to explain the observed benefit of VASCEPA over placebo.
Each of the three VASCEPA clinical trials, MARINE, ANCHOR and REDUCE-IT, was conducted under a special protocol, or SPA, agreement with FDA in which mineral oil was agreed with FDA as an acceptable placebo."
https://www.vascepahcp.com/vascepa-efficacy/anchor-study/
And you are trying to argue that the FDA are going to turn around after all of the above and after the sponsor has spent over 6 years and around $500M on trials, and deny approval based on the placebo and unsupported claims of mineral oil affecting absorption? Completely ridiculous.
Thanks for posting. A very thoughtful analysis.
No doubt that there's an art to TA. With such a vast selection of technical instruments to choose from, human analysis and interpretation of the data is obviously highly subjective. Two people can look at the exact same data points using the same TA tools and come to completely different conclusions, and two people can look at completely different data points using completely different technical tools and arrive at the exact same conclusions. There is no gold standard and no fool proof 100% guaranteed method of success in terms of accurately predicting future prices. How accurate would you say that your methods are? 70%? Higher?
"Once AMRN prints $24, there is no overhead resistance and the ride to $30 should be pretty quick..."
One caveat to that. If $24 is printed on a daily/hourly/minute time-frame it carries far less weight than if printed on a weekly/monthly time-frame IMO. Would you agree? Based on the TA methods that I use, I want to see a $24+ close posted on a weekly/monthly price bar before I start getting excited about the prospect of it going to $30 and beyond.
JMO. I hold a very modest amount of AMRN shares and don't day trade the stock.
Thanks for the message. I'm a purist when it comes to price gaps so i'm still very wary of that gap between 16.12 - 16.28. The story obviously unfolds day by day, week by week, and month by month so still too early to tell what will happen in January yet, but with what i currently see im thinking that its taken down to fill that gap and then even further down to the $15s and maybe even briefly to the $14s.
The volume has to do with the decent amount of selling that occurred down there on the 13th and 14th - weak hands that need to be shaken down - and i'm fairly certain a good amount of them are still around.
I'm looking for a close at or above 20.83 next week for the end of the month. That would be a very bullish signal for me with this stock for 2019. I'm looking for a close above 23.34 end of year then. If we get that I think you're correct and it will continue on up without filling the gap. I have my doubts though and think it fails to overcome the resistance around 23.
We shall see. Best of luck however you're trading it anyway.
But there is no data -that's the whole point! You know your way around the published scientific literature and i know you've been digging very very deep trying to find some of the "substantial data" that Nissen claims exists. So far I haven't seen a shred of it which tells me that Nissen is either spoofing, flat out wrong, or straight up lying. You've trawled through studies from India, Iran and also presented rat studies but I see nothing that will even remotely concern the FDA.
That study is absolutely worthless.
They didn't even write the correct dose:
"Participants received 4 mg of omega-3 (EPA: 720 mg, DHA: 480 mg)..."
4mg?
And on top of that they don't even include the baseline LDL-C and hsCRP values. "Jumped 9.43mg/dL" from what? 142mgs/dL? hsCRP "jumped 0.68" from what? 2.8? This is important information that has been completely omitted.
Ok Raf that's great. Have an awesome day now.
Thanks for the reply.
"It's key to understand that not all LDL is created equally."
Agreed. And HDL-C for that matter. There are huge misconceptions about what HDL and LDL are and what they do.
LDL is commonly regarded as 'bad' cholesterol, and HDL 'good' cholesterol, but these ideas are completely outdated.
LDL can be subdivided further into LDL pattern A and LDL pattern B.
Pattern A LDL are large, fluffly particles. Pattern B are small, dense LDL particles. How each of these affect blood vessels and heart health is very different.
Pattern B LDL (small and dense) is the dangerous one. These small, dense particles can easily lodge between the cells lining blood vessels. Once there they oxidize (become rancid). They also cause inflammation. Over time they create artery clogging plaque.
By contrast, pattern A LDL (big and fluffy) does not lodge between cells. Some people speculate that this is the beneficial form of LDL because of this. In fact, LDL in its good form is essential for building muscle. It is also associated with low triglycerides.
https://ezinearticles.com/?Cholesterol:-Are-You-a-Type-A-or-Type-B?&id=6346260
If Epanova achieves a decent RRR but raises LDL-C significantly, I wish AZN the very best of luck arguing their case with the FDA. If GSK couldn't do it I don't see how AZN can.
HDL is not all the same either. HDL-2 particles appear to be anti-inflammatory and protective whereas HDL-3 appear to be pro-inflammatory. The literature is still fairly sparce still though.
Thanks for posting.
A lot of hypotheticals going on there :)
Out of curiosity, why have you focused on atorvastatin? Weren't the patient's in R-IT on different brands of statins?
Upset? :D Like you were when you had my past 2 weekly predictions bookmarked - itching to dig the knife in - but you didn't get the chance to because they were correct? Lets see how next week's prediction works out. I'm on for 3 in a row now Raf. Up to the low $20's where it will close by Friday IMO. Incorrect predictions happen. Particularly when day trading. I'm fine with them but aim to limit them.
"The last guy here who tried PPS predictions, didn't do so well."
And if he couldn't do it no-one can, is that the idea? Seems like bizarre logic to me.
Explain to me your opinion on how multi-billion dollar hedge funds make their money will you? Tell me about algorithmic trading and the strategies that hedge funds use to make profits from stock trading. Or do they all just buy stock purely based on fundamentals and trade them without any real clue in which direction the markets will move short term and long term? Pure blind speculation is it?
Agreed. It's all educated guess work really. Too many variables involved to be able to accurately predict the outcome.
"Storm is a brew perhaps. Let's see if they don't slam this down to the $14's again by Thursday."
"Perhaps (adverb): possibly but not certainly"
You are correct. It didn't dip below mid $16 again - I had my doubts that it would - and it didn't - this week - but it certainly will IMO at some stage over the coming months. Mark this post.
Any stock price predictions yourself there Raf? Up is it? Perhaps? Certainly? Do you really have any idea or are you simply holding the stock based on optimism and on a wing and a prayer? Hopefully it keeps rising and then you're gonna sell?
Should we all just ignore the technical aspect to trading and do as you do? Is what you believe the most important thing around here? Should we not maybe respect each others opinions and differing approaches to trading this stock?
You tell me.
Good call on the close above $19 :) I thought that they would close it under 18.50 and screw over the 18.50 and 19 strikes for sure. Bodes well for next week anyway and a move back up into the low $20's.
I think profit taking starts the week of Dec 17-21. Should bounce off the resistance around $23 and start trending back down towards slowly $14 after that. Too much volume down there at $14-15 for them not to re-test that area and pick up more cheap shares. Still a gap in the low $16's between 16.28 and 16.12 that need to be filled also. I'm think by the end of January and February. Should start creeping back up in March towards $20 again. After that in April/May it will blow past $24.
What's your thinking?
Funny, you had nothing to say the past two weeks when my weekly predictions were accurate.
The STRENGTH trial is 4g of Epanova at 55% EPA and 20% DHA to be accurate. So they have about half of the good stuff Amarin has, and the other half is the DHA and filler which is liked to raising LDL-C. I personally can't make head nor tail of why they are even running the STRENGTH trial knowing Lovaza's effect on LDL-C. Lovaza is 47% EPA, 38% DHA, and the rest filler. Lovaza raises LDL-C by 45%.
Thanks. No flies on Dr. Bhatt. I consider myself to be fairly up to speed with the science surrounding all this stuff, but Dr Bhatt would still run rings around me.
He has over 750 peer-reviewed publications! The man is a machine :)
https://physiciandirectory.brighamandwomens.org/details/416/deepak-bhatt-cardiovascular_medicine-boston
Yes, I called it on here before it happened.
Also called the drop in price this week with others doubting that there would be any drop:
I said the share price will drop back down well below $18, more than likely into the $14's, on less volume than it did last week. I also said the price will have recovered by the end of the week.
ziploc_1:
"I doubt it....The take down last week was kind of a perfect storm"
BostonTrader:
"There are a few reasons I don’t see a retest or even getting below $17. The first being that option open interest is not anywhere near as high as it was last week."
Went down to the low $16's. Volume 140M last week; 26M this week which is significantly less volume than last week irrespective of the holiday and half day today. Will close around $18 - $18.50 today.
The fact that it wasn't taken down to the $14's tells me that they will be back again at a later date. I see low $20's next week and the week after. Will more than likely bounce off the resistance around $24 end of December and head back down during January and February. By March it should be on its way back up again IMO.
Thanks.
"Both James Stein and Ethan Weiss have moderated their stance and I think in general adopted a positive interpretation of reduce it data. This is evident through their tweets. Sekar Kathiresan has turned very positive and probably the staunchest supporter of reduce it on twitter."
So what's changed? The data looks the exact same to me as it was when it was first published in the NEJM. Looks like a fair amount of scrambling and back-tracking going on from where im sitting. Any ideas on why that might be?
I did some digging into that Herper article that was released right after the AHA meeting:
https://www.forbes.com/sites/matthewherper/2018/11/10/fish-oil-derived-drug-shows-great-promise--with-big-caveats/#2d253e7b3291
"...the result comes with a major asterisk. Cardiologists who reviewed the data for Forbes see a big problem with the study...."
Herper cites Harlan Krumholz first who is not exactly blown away by the R-IT data. He seems to think Vascepa is little more than an omega-3 supplement and published this in August:
https://www.jwatch.org/na47431/2018/08/26/do-n-3-supplements-prevent-cardiovascular-disease-patients
The R-IT data proves him wrong.
Next up is Stephen Nissen who doesn't appear to be very impressed either. He's the principal investigator of AZN's STRENGTH trial - a competing drug to Vascepa. Obvious conflict of interest there with his opinion.
Krumholz and Nissen have worked together before:
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000144
Next is the cardiologist Ethan Weiss who has placebo issues. Not a whole lot I can find with him in terms of conflicts of interest but Herper has quoted both him and Nissen in the same article before:
https://www.forbes.com/sites/matthewherper/2014/06/19/dna-studies-show-triglycerides-cause-heart-attacks-pointing-to-new-treatments/#451540784241
Next is cardiologist James Stein who is highly skeptical. He's mentioned in the same article as Nissen here, offering "strong support for Nissen":
http://www.cardiobrief.org/2017/07/24/nissen-calls-statin-denialism-a-deadly-internet-driven-cult/
Next up Sekar Kathiresan, another with placbo issues. He's received research grants from both AZN and Amarin.
Next Deepak Bhatt, obviously positive, and with obvious ties to Amarin.
Finally, Sanjay Kaul who is very positive. He seems to have had conflict of opinion with Niessen before:
https://www.medicinenet.com/script/main/art.asp?articlekey=83099
Unbiased and impartial opinions? Not by a long way.
Well said. Not familiar with the DCTH CRL and i don't dare look :)
My own take is that there can be 'factors' at work behind the scenes that the general public are not privy to when it comes to these FDA decisions - completely unrelated to the science - that can sway FDA opinion (it is a government agency after all). The FDA should be completely impartial and non-biased of course but you know how things work on this wacky planet. It is what it is.
From where im sitting the benefit and safety profile are undeniable here so id give it an 80/20 chance of being approved. I can't say ill be betting much money on it though :) If BP buyout Amarin over the next few months on the other hand I think its chances of approval increase to 95/5.
Publish away my good man. I'll be more than happy to dismantle it for you :) Just be sure that any claims you make in reference to statins/mineral oil/absorption are backed up and referenced with robust scientific data - and preferably on human beings rather than rats ;)
"...still not at all sure how FDA will handle the issue"
I'm not entirely sure either, but going off the FDA's comments at the ANCHOR ADCOM i'd be inclined to believe that it does get approval:
"the critical question which patients care about is ultimately, do the observed changes in lipids and lipoproteins with Vascepa while treated with statins translate into a benefit on cardiovascular outcomes?"
So lets look at the R-IT Vascepa data:
TGs: -22%
non-HDL-C: -4%
LDL-C: +3% (and still well under 80mgs/dL)
HDL-C: +3%
ApoB: -3%
hsCRP: -13%
EPA: +394%
And the above translated into a 25% RRR in MACE, a 28% reduction in stroke, 31% reduction in heart attacks etc etc.
Looks like an open and shut case to me. The only thing that concerns me slightly is the 'fish oils' as a drug class thing. No reason why they should wait for STRENGTH with RRR of 25% and greater in R-IT with no serious adverse side effects, but you never know. Whatever way you slice it Vascepa and EPA are in a class of their own so it's completely unfair/unscientific to compare Vascepa to any fish oil containing DHA.
Another prominent European cardiologist impressed with the R-IT data:
"By the way, will the best biomarker of clinical response to this drug end up being plasma EPA level itself?"
YES! :) That and hsCRP. But you may as well also add the Arachidonic Acid (AA) biomarker into the mix and start evaluating patients EPA/AA ratios.
"A total of 284 consecutive patients who underwent elective PCI were enrolled and stratified according to median serum levels of n-6 PUFAs (arachidonic acid [AA]), n-3 PUFAs (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), and serum EPA/AA and DHA/AA ratios. The relationship between these PUFA parameters and the incidence of MACE including cardiac death, acute coronary syndrome, PCI for de novo lesions, and coronary artery bypass grafting, was analyzed. Multivariate analysis showed that among the PUFA parameters, only a high serum EPA/AA ratio was significantly associated with a low incidence of MACE in all the models tested."
https://www.jstage.jst.go.jp/article/circj/76/2/76_CJ-11-0941/_article
Another paper re EPA/AA and coronary plaque:
https://www.jstage.jst.go.jp/article/circj/75/10/75_CJ-11-0352/_article
"Association of serum levels of arachidonic acid and eicosapentaenoic acid with prevalence of major adverse cardiac events after acute myocardial infarction"
https://www.jstage.jst.go.jp/article/circj/75/10/75_CJ-11-0352/_article
I just can't wrap my head around the idea that people can't wrap their heads around the differences between EPA and DHA. There's a mountain of scientific literature on EPA and DHA and the obvious differences between them if anyone actually bothered to look. Blaming the MO for the high RRR is far more convenient though and far less intellectually taxing. Willful ignorance and blinkers are fine to hide behind short term but they will always come back to bite you in the ass in the long run.
I'm torn between the STRENGTH trial and what im hoping for. From the perspective of science and patient benefit i'd love to see them turn out a 26% primary RRR. But based on the available scientific evidence I don't see it happening. A 5-10% RRR is my guess. If you are in the 'fish oil' as a class of drugs camp, then this result would be ideal for Amarin as it would further validate this supposed class of Rx drugs, with Vascepa and EPA still being best in class (and in reality being in a class of it's own). But you would then have the issue with all the OTC fish oils trying to crash the party and steal market share. So for Amarin it is probably better if STRENGTH achieves its primary RRR but fails to get approval because it raises LDL-C significantly, as Lovaza did. The finger then gets pointed squarely at DHA. But what will the 'drugs as a class' brigade say then? Some skewed logic about not having enough evidence to truly initiate the paradigm shift because only 1 'fish oil' has ever showed any real benefit? Completely ridiculous but it wouldn't surprise me.
Thanks for the link. Well he has his work cut out this time. I look forward to reading all about the "considerable data" that he says he has:
"...there's considerable data that mineral oil interferes with the absorption of statins."
5m47s - 5m55s
Raf,
I agree with you. I'm cutting the guy a lot of slack. If he waited a few days after the AHA meeting and released this latest article then instead of the one he did, there would be no issue here for me. The latest piece is far more balanced at least in terms of the opinions presented and who the opinions are from. From a science perspective it obviously still falls way way short of the mark but at least he's attempted to frame the debate better - a non-existent debate as far as i'm concerned when you look into the data and science - but an apparent debate nonetheless, and one that you can trace back to Nissen.
Who knows, maybe he'll write a 4th article and get stuck into the science and conclude that the dissenters had it all wrong. I wouldn't hold my breath waiting for it though - this is FORBES we're talking about (a business magazine). There will be far more balanced and well researched pieces released elsewhere in the coming months. There should be some decent editorials in the NEJM.
Thanks for the message. Exactly. The trick with scientific evidence is to observe the totality of the evidence and do it without bias or judgement -if you want to arrive at the truth. If you have skin in the game or an axe to grind then your interpretation of the data and your conclusions will always be biased. Good thing for Amarin that it's the FDA who will determine whether or not they will get the label expansion and not AZN and Nissen. There's simply no weight to their arguments in the available scientific literature, and they know it, which is why there is talk of running a placebo statin trial in a desperate attempt to create some data, rather than taking a step back and trying to better understand EPA and the data for what it is - spectacular for all the right reasons IMO.
It's all a game of polarity (duality) at the end of the day - negativity/positivity, joy/misery, virtue/vice, love/hate, darkness/light etc etc.
I'm not certain about how things work in the courts but my understanding is that it all boils down to 'intent'. What is/was Nissen's and AZN's 'intent'. What was Herper's 'intent' with his article after the AHA meeting. Whatever about that, I think I know what his intent was with yesterday's article, and I think you do too :)
I couldn't help but notice that the hedge funds were on their best behavior yesterday. The DOW down 550 and another Herper article released, the perfect opportunity to attack Amarin you would think, yet the share price closed the day flat at precisely 0% on low volume. Nothing to see here SEC :)
I had another read of Herper's latest article there. I like it. For me it's balanced journalism and well researched, but the central theme itself is ridiculous.
Look at the title: "Is Amarin’s Fish-Oil-Derived Drug A Historic Breakthrough Or Not? It’s Complicated"
Complicated for who exactly? Those with bruised ego's who fully expected R-IT to fail spectacularly and are now scrambling to make sense of why they were so wrong? There is nothing complicated about this for me at all. I did my DD and researched the subject matter thoroughly before I bought my shares, and to me there is nothing complicated about it. Nor is it complicated for Dr. Bhatt, the AHA, the NEJM, Amarin, the ACC, and most of the cardiologists and doctors who have looked at the data. So what is the issue here?
The issue is a complete lack of respect towards Amarin, Dr Doogan (former head of R&D at Pfizer before he joined Amarin and designed their trials), the Baker Bros, and also the FDA themselves. All of the above have carefully scrutinized both EPA and the mineral oil placebo well before all the Johnny-come-lately's ever arrived, and they all gave it two thumbs up (the FDA one thumbs up perhaps at the ANCHOR ADCOM as a precaution until the R-IT data was known-overly cautious IMO but considering the size of the potential patient population maybe sensible).
Anyone focusing on the mineral oil placebo as a scapegoat to explain the amazing RRR simply does not understand how the human body and diet works, doesn't understand the scientific literature well enough, and doesn't understand how EPA works and what 'fish oils' actually are.
IMO, the main reason why the majority of the investment community thought that R-IT would fail was because they thought that it was 'just another fish oil'. I've been hearing them bang the same drum for years. It is not another fish oil. Fish oil's by definition are composed of various different omega's (3,6,9 etc), and will typically contain very small amounts of EPA alongside DHA as their main ingredients. This, combined with the small 1-2g doses used in previous studies is the reason why so many of them failed to show any efficacy. The R-IT results are what happens when you ditch the DHA and other omega fillers, and you get the dosage correct - AND you have patients with optimal LDL-C levels on statins.
The only studies worth their salt while trying to determine if R-IT would succeed or not was the JELIS, MARINE, and ANCHOR studies. All other studies were largely invalid because of the DHA and other fillers, and lack of statins.
The naysayers would have had the R-IT RRR down for around 2-12% maximum IMO because they thought it was 'fish oil'. If it was any higher than that, then they could just say that the results were inflated because of the mineral oil (which they also didn't understand).
So the initial RRR was released at the end of September and showed the primary RRR at 25%. 'What?!' 'No way no how!' 'No way we have this wrong.' 'It's the mineral oil! Has to be!' 'Let's get them the week after the AHA when they least expect it'. 'Not a hope in hell the data is clean.'
But now that the dust has settled, it turns out that on closer inspection, and with a better understanding of the data, they got it wrong on both accounts. The RRR has nothing to do with the placebo, and was as high as it was because of the EPA and dose. Experts from Oxford and Harvard are agreed. The only ones that I can find that have any real issue with the data are Dr. Nissen and his associates working with AZN on the STRENGTH trial. Ain't that somethin'.
And AZN changed their placebo from olive oil in the EVOLVE trial to corn oil in the STRENGTH trial - 'very fishy' some might say,
"But I just did..."