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Advisory Committee meeting notification? In the latest press release, Amarin stated:
One cardiologist’s interesting take on Lovaza vs high-purity fish oil supplements. Relevant to the discussion on Vascepa vs OmegaVia EPA:
http://www.cureality.com/blog/post/2009/03/24/do-you-work-for-the-pharmaceutical-industry.html
-MRC
Calmustang,
That’s not for all meds, only heat sensitive (insulin, etc). Also, it is outbound. Do you have evidence that (a) pharmacies care at all about temp control for Vacsepa/Lovaza specifically, and (b) that they are packaged and sent to pharmacies in temp control containers from the manufacturer?
-MRC
Have you seen the talent Matinas has attracted? That actually came to them? It’s worth looking into.
As said in the last post, you may be better served thinking of this as the evolving statin market. Once 4S established the efficacy of HMG-CoA reductase inhibitors to reduce ASCVD, numerous other HMG-CoA reductase inhibitors came out that did not have outcomes studies, but docs prescribed them anyway over the older versions. Why? They were better at doing what they were designed to: lower lipids and inflammation. Now, there are rTG and other forms of EPA our there, and they are better than EE forms like Vascepa. There’s just no denying it. It’s a significant headwind for AMRN bulls.
On MAT-9001 we went patent diving and found some very interesting things. It’s essentially 85% free fatty acid EPA and around 10% FFA-DPA. Think of an Epanova analogue to Vacsepa, with some DPA to differentiate IP. If Amarin makes it, they will run their hypertrig study and get on the market fast. Then it’s up to docs, who may very well choose it over Vacsepa.
But Amarin is not likely to make it. Highly probable they will be delisted before end 2022, or cease to be a going concern altogether by then.
-MRC
Could a generic Vascepa make the same claim? Yes. Why? It delivers the same or better API, which is in this case EPA.
There’s no escaping it. If increasing EPA serum levels to or beyond a certain level (the entire point and only relevance to taking Vascepa) reduces your risk of ASCVD, then that can be had in a number of ways, from a number of different supplements. Amarin themselves admit this when they erroneously state “it would take X number of fish oil pills to get that much EPA” in one of their adverts.
Think of the statin market. Once it was known that HMG-CoA reductase inhibitors reduced risk of ASCVD, lots of different kinds came out, all under the same category (HMG-CoA reductase inhibitors). There was a link in the reduction of LDL-C, and theories that HMG-CoA reductase inhibitors that lowered LDL-C more were more effective than those that didn’t as much. Which is probably true. By extension, these are all EPA supplements. Vascepa really is an EPA supplement. It’s designed to get EPA into your blood. So these are all the same kind of “drug.” Think of Vacsepa as the 1.0 lovastatin, and OmegaVia EPA as the better, 2.0 atorvastatin. Same concept.
Regards,
-MRC
And where is that quote from? The most reliable data from numerous studies confirm greater bioavailability of rTG form vs EE—and especially when taken with lower fat meal or no meal.
Here are two decent little overviews:
https://shorthillseye.com/fish-oil-triglycerides-vs-ethyl-esters/
https://www.civicnutrition.com/blogs/news/choose-triglyceride-fish-oil-instead-of-ethyl-ester-fish-oil
-MRC
Whalatane,
Numerous inaccuracies here. For one, these manufacturers all use “hot trucks” to transport product to pharmacies/ your home. If it is a problem (and not at all convinced of that), it affects both. Walking into an air conditioned pharmacy may have given you the illusion it was born and always kept in a cool dark place, but that isn’t reality.
Secondly, the actual amount of EPA is 500 mg in each 500 mg capsule. The IFOS data also confirm this. Where are you getting your 85% from?
https://omegavia.com/frequently-asked-questions-omegavia-epa-500/
For Vascepa, they state “at least 96% EPA-E,” or 960 mg per 1 g cap. So OmegaVia likely has more API than Vascepa.
Regards,
-MRC
It’s difficult to take anyone’s anecdote very seriously. There are serious control issues involved in off the cuff, at home on your own self-studies. This person had a different experience than you:
Yes, taking rTG form with food increases absorption a bit. Now compare rTG on empty stomach with ethyl ester on empty stomach. The rTG goes down to about 70%-80% efficiency, while ethyl ester does all the way down to ~20%. A similar thing happens with a very low fat meal. Which, btw, fat content of meal is not in the Vaacepa label, despite its high importance regarding bioavailability of the “drug.”
And the pills are much easier to swallow as 500mg.
-MRC
Well wait—you helped make my point. The numerous failed omega-3 studies used prescription ethyl ester omega-3s (Lovaza). Is that a supplement, or a drug? You think the studies failed because you think it takes 4 g/d EPA only to reduce ASCVD risk in at-risk subjects, yes? Not because Lovaza was a supplement and not a drug.
EPA is EPA is EPA. If you believe REDUCE-IT, you believe above a certain threshold of EPA absorption (perhaps absent DHA, etc) lowers your risk of ASCVD. So, take OmegaVia EPA 500, and get that EPA. Get even more than Vascepa will give you, and get it without the need to also take the pills with a high fat meal every single time, and without the potential organ damage from years of ingesting fatty acid ethyl esters.
This is easy. It’s not hard. It’s a supplement. It’s a nutrient, that you can supplement your diet with. It’s not even a debatable point.
Regards,
-MRC
fordyoz, the point is the API; that’s all AHA was saying. Just get the right amount of API, with as little harmful non-API as possible. With EPA it’s easy. You guys tout the EPA/AA ratio a lot, right? More EPA = better, meaning lower ASCVD risk, yes? So get OmegaVia EPA 500. Cheaper, better formulation (don’t have to worry about how much fat is in the meal you are taking it with, or if you’re even taking it with a meal—and no potential organ damage from fatty acid ethyl esters), and extremely easy to get (on Amazon).
The outcomes study is done. It proved to you all that a high dose of EPA every day lowers risk of ASCVD. Easy. Take OmegaVia EPA 500. This couldn’t be easier.
Kind Regards,
-MRC Team
No, there are extensive third-party CoAs done on the supplements that should be recommended (like OmegaVia). The CoAs are publicly available. At the very least, physicians should educate themselves and allow that knowledge to better help them on recommending what treatment to take for their patients.
If you are vitamin D or iron deficient, simply purchase a well regarded vit D or iron supplement from a company with a publicly available CoA. If you would be benefited by 4 g/d EPA, take OmegaVia EPA 500 in the better absorbed rTG form, not dependent upon being consumed with high fat meal for absorption, held to higher standards than USP-NF (regulates Vascepa) on PV and p-AV (TOTOX), and is manufactured in FDA CGMP regulated facilities. Get more consistently absorbed EPA, save a lot of money (1/7th the cost), and don’t have to worry about potential long term deleterious effects of fatty acid ethyl esters, which have been implicated in organ insult.
As stated to bfost, it should be thought of more like a generic drug. What matters is the API and getting that into your bloodstream. Once you know a certain amount of API has an effect via outcomes studies, you only need to prove you are getting the API. OmegaVia gives you the API (EPA), and even better and more consistently than Vascepa. In fact if they could make Vascepa over again (developed in the 1990s) today, and IP weren’t an issue, they would probably make it just like OmegaVia EPA. Because, frankly, it’s better.
This is also why Matinas Biopharma is a real threat to Amarin—if AMRN makes it far enough that it will mater.
Regards,
-MRC
fordyoz, no just quoting the AHA from ca. 2002:
“Patients with CHD should be encouraged to increase their consumption of EPA and DHA to ˜1 g/d, which is the dose used in the GISSI-Prevention Study. Table 3 presents omega-3 fatty acid content of various fish and supplements as well as the amount required each day to provide ˜1 g/d of EPA+DHA. Although this level of EPA and DHA intake potentially can be attained through fish consumption, the requisite amount of fish intake may be difficult to achieve and sustain over the long term. For those individuals who do not eat fish, have limited access to a variety of fish, or cannot afford to purchase fish, a fish oil supplement may be considered. Depending on the preparation, up to three 1-g fish oil capsules per day will be necessary to provide ˜1 g/d of omega-3 fatty acids. The most common fish oil capsules in the United States today provide 180 mg of EPA and 120 mg DHA per capsule. It is important that consumers read the nutrition label to determine EPA and DHA levels in the fish oil capsule.”
https://www.ahajournals.org/doi/full/10.1161/01.CIR.0000038493.65177.94
No, doctors and the AHA were doing and recommending doing just that after GISSI-P data.
Apples and oranges. You are first of all talking about a device, not a “drug” with almost no SAEs (i.e. Vascepa), and secondly a device that if manufactured deficiently would result in extreme morbidity.
As stated, FDA applies a risk-based approach to CGMP compliance surveillance.
Regards,
-MRC
“Noeructation” (these handles!) and also to north40000,
NoE, we agree, you’ve outlined that well. And we are sure you are mindful that there are prescription vitamins with equivalent dietary supplements, for instance vitamin D. Are you really that much better off getting a prescription vitamin D supplement vs a vitamin D dietary supplement? We aren’t talking about dangerous APIs here. We’re talking about refined fish oil.
What does FDA actually do to regulate drug products like Vascepa, and does that make Vacsepa safer than/better than products like OmegaVia? FDA has a risk-assessment approach to surveillance of drug manufacturing facilities to ensure they are operating under CGMP guidelines. For a product like Vascepa, with a very low risk profile, and overseas facilities, they probably have only gotten one or at most two abbreviated inspections since 2012. These inspections almost never actually take test sample of the product and run CoAs. They are examining the facility itself, the equipment, health and safety standards of the workers, and other various compliance measures. The FDA runs a full inspection pre approval, but once things are running with no major unprompted issues being alerted to them, they don’t look very often, and when they do, they don’t look very hard. And again, no certificates of analysis (CoAs) unless for very good reason.
Okay so if workers aren’t wearing appropriate attire, or condensation is leaking into a batch, or paint is peeling on multiple walls, or equipment is past due on maintenance, they issue a warning to get those items resolved, and check back to make sure they are, and then they’re off and running.
In one sense these regulations can be a hinderance to drug innovation because if there is new tech or process discovered and you want to adopt the change to make it better, you have to go through hoops. So drug companies most often keep the same old process and formulas without any changes for sometimes 20+ years.
A company like OmegaVia runs CoAs all the time, and has its product produced in facilities that are also FDA CGMP compliant. For example, as per these FAQs:
I’m sorry, but I can’t reveal my profession. The strength of an argument must be based solely on the argument itself, and how compelling the evidence presented to substantiate the argument, not the credentials of the one making the argument. Otherwise, a truth spoken by one without an advanced degree or position will not be regarded as truth, and an untruth spoken by one with an advanced degree or position will be regarded as truth.
When it comes to authority, and execution of power, credentials are paramount. Because power is given by the people and for the people, and must be earned by established designation (MD, JD, Captain, Senator). Here, we are debating truisms, that live or die based on the strength of the evidence presented alone.
Regards,
-MRC
“Told us so?” We think there is a roughly 40% chance the Vascepa efficacy supplement gets approved without a hitch. We wouldn’t be very surprised if FDA responded to our petition by stating that they have determined the issues brought to light were not significant enough to require DDI studies. We think it is more likely they agree with our analysis, and have perhaps been turned on to a point or two that they then looked deeper at and may have realized in the abundance of data that only they and the sponsor can see that there are numerous red flags that justify requesting DDI studies of Amarin. We also think >85% chance they lose the patent litigation cases in late Jan/early Feb (most ANDA bench trials resolve in under 8 days).
Here’s the low down: if the above odds more accurately reflect the risk:reward of AMRN, and considering realistic projected peak sales, the stock should be trading nearer to a $1.2B market cap, not over $7B. Instead, the market obviously thinks well over 90% chance approval without hitch, and about equal for patent litigation win.
Essentially all stocks are speculative investments, and some carry far greater risks than others. High risk should de facto stifle the market cap relative to conservative future peak sales estimates. It hasn’t here because the market does not think the risk is at all high. Our analysis has revealed the market is quite wrong about that.
And so, it’s a bit more complex than “right,” and “wrong.” The best analogy is gaming. If someone walks up to a roulette table and places chips on 15 numbers, and wins, were they right? If they lose, were they wrong? No, they are “wrong” regardless, because they weren’t “getting odds,” as they say.
We don’t recommend this of that position on a stock, but our analysis has revealed that AMRN is severely overvalued, and far riskier to own than the market has given it credit for.
Regards,
-MRC
What do you think “regulated by FDA” actually means? Do you think FDA visits Amarin’s manufacturers or swipes a bottle of Vacsepa and does chemical analysis of it every 6 months? Or requires Amarin run CoAs routinely and submit them to FDA? You don’t actually know what “regulated by FDA” means, do you?
In actuality, OmegaVia is better regulated than Vascepa. There is just a lot of misinformation out there as to what the quality of an FDA approved drug product entails. Another example is vitamin D. There are prescription forms, for infants etc., or you may purchase them as supplements and save some money. Physicians “prescribe” supplements all the time, perhaps advising certain brands as more reliable, and that is that. Everything does not need a script. The ones apparently most bothered by the idea of taking OmegaVia EPA instead of Vascepa are AMRN bulls. Imagine why?
Do as you wish, but as a physician, recommending patients take a lower than recommended dose of a brand name “drug” to save them money when there are cheaper, better absorbed alternatives out there, is not good practice.
Regards,
-MRC
Massulo, I’m afraid you’ve missed the point completely. The only rationale given by that physician to take 2 g/d Vascepa for at-risk patients is because 4 g/d is currently too expensive. And, presumably, because telling people to turn to third-party tested supplements that show exceptional TOTOX scores and accurate or better levels of stated API (EPA) to get their 4 g/d of EPA would not benefit the company they are invested in. That is deplorable.
Regards,
-MRC
bfost, have you ever prescribed a generic before? Did you not realize those generics are not exactly the same as the reference listed drug (RLD), sometimes even using a different carrier of the API altogether? Did you know that generics aren’t required to be tested in outcomes studies, but may rely on the studies of the RLD? Did you know that the active pharmaceutical ingredient (API), and extent of API absorption, especially “not less than 90% of RLD” is all that FDA is concerned with? Did you know the API of Vacsepa is not necessarily ethyl ester EPA, but just EPA? Because it is broken down and absorbed as EPA in serum, and that is the relevance of ethyl ester EPA, to allow EPA to be absorbed? I’m asking because your continued request for outcomes studies for what is in every relevant way generic Vascepa, and a type that actually delivers at least equivalent but most often more API to the patient (and more consistently, not requiring high fat meal for max absorption), shows a lack of understanding in this regard, one that a physician truly ought to possess.
If you are very hard up on the ethyl ester form (which ignores a good deal of reliable data for rTG form), then there are Carlson Labs’ “EPA Gems,” and Minami’s “Plus EPA,” and also HormoneSynergy’s “Synergy Pure EPA,” that all have updated CoAs that show the same exceptional purity as OmegaVia, but are in ethyl ester form.
Advising your patients to take half the dose of REDUCE-IT, when you believe REDUCE-IT, is terrible practice. If you believe REDUCE-IT, you must get them the same levels of API. That should be your goal. Not recommend half-doses of the brand made by a company you are invested in, based on spurious, open-label JELIS data, that showed an equally comparative RRR (with strokes included) of only an insignificant 11.5%.
-MRC
Citizen Petition Submission no.3
Many research papers highlight only the downside or detraction to a position, especially in response to overly-positive papers that promulgate an idea. Our report specifically set out to see what detractions there could be in the REDUCE-IT data, to counter-balance the absolute flood of positive writing on the trial, and because the scientific method demands it.
Do not forget, a clinical trial is designed to prove a hypothesis wrong, not right.
https://blogs.stjude.org/progress/hypothesis-must-be-falsifiable/
We seriously doubt many AMRN bulls have read much of our citizen petition, much in the same way a certain poster here, despite his great expertise in patent law, has not even examined the Vascepa IP. It is a form of denial. The inability to truly and exhaustively seek to refute something you believe, something you very much want to be true.
Kind Regards,
-MRC
Yes, most likely window. Later is still quite possible (through next week even). After the 22nd very unlikely. That is because the mid-cycle review took place on or around June 28th, and the FDA sets a goal of "within two weeks" from that review to communicate the content of the review with the applicant that they can share, and that may assist with the review process. Sometimes the mid-cycle review occurs a bit earlier than exactly "3 months" for priority reviews, and the mid-cycle communication sometimes comes early in the "within two weeks" window. So, for Amarin, 6/26 - 7/10 is a most likely window. It is still not improbable for the mid-cycle communication to come on the 12th, or 15th, or 18th for Amarin.
If we get through 7/22 and no word on AC meeting, then there probably won't be one.
Regards,
-MRC
Companies with drug candidates, and/or just the drug candidates themselves, targeting NASH resolution. There are quite a few.
We have also gotten interest in performing customized analyses. We see that being largely the direction our firm will go in. These reports will be privately distributed to the respective clients that commission us to perform these targeted analyses, and you'll never see them, unless our clients subsequently decide to publicly disseminate them.
Our analysis on Amarin Corp. is our first as a company, and we are babysitting it a bit if you will. We are also conducting an activist campaign of our own volition, to set precedent, and because as always, we very much believe in the strength of our analysis, and feel it may help over-burdened regulators.
Regards,
-MRC Team
High-EPA dietary supplements that can be purchased without a prescription (very convenient) are better than Vascepa in multiple ways. And if 4 g/d Vascepa, or the end result of taking this supplement, which is a sharp increase in serum EPA levels, can reduce the risk of ASCVD, then this advice may harm at-risk patients:
Citizen Petition Submission no.2
Honestly, we’re concerned. No one, including their families as a result of their irresponsibility, has to get badly hurt here. That’s why hedges exist, and that’s why registered investment advisors exist, to help market participants mitigate risk and make investments that can help secure their future and those whom they affect. A number of AMRN bulls have proudly admitted to being “all-in” without any hedge at all. Many are older men with families that depend on them. That is terribly reckless, and we can’t help but feel for what we see as likely to happen to them. Call it a sense of obligation to a least mention it. It can, along with everything else we write, of course be ignored.
Good luck to you.
-MRC
To our knowledge, it was not company policy at that time that insiders acquire and dispose of securities pursuant to 10b5-1 trading plans. Perhaps after the fallout of ANCHOR SPA rescindment and the legal difficulties that followed they were instituted.
Also, keep in mind that seeing a sale pursuant to a 10b5-1 plan does not tell you very much unless other details are also divulged. Most common for such plans is a 30-day restrictive trading window or less. For all we know the insider sales 7/1 - 7/5 were set up in early-to-mid June.
https://advisor.morganstanley.com/capitol-wealth-management-group/documents/field/c/ca/capitol-wealth-management-group/Defining_the_Fine_Line___Locked_Version.pdf
Regards,
-MRC
HDGabor, well at least on the AC meeting we should have a clear idea over the next two weeks. On our CP, we think it will have a modest impact, but an impact nonetheless. If you analyze past CPs that weren’t filed in an attempt to thwart generic entry, the statistics are more favorable. We also have evidence that private dialogue has been effective with the agency, and have previous to our submission engaged in that route as well.
Regards,
-MRC
Well it appears a litigious threat at least got them to take off the Vacsepa mention comparison. How sad is it that this company has to defend against supplement merchants selling the exact same thing as their “drug” on Amazon and elsewhere?
HDGabor, the quantity and price are:
Unfortunately, that’s what happens when your API, including any uses of your API, isn’t proprietary:
It is truly amazing to witness all of the acrobatics that AMRN bulls will perform to ignore the obvious. JZ’s most recent sell-off of shares, which further makes the recent pump PR very suspiciously timed and adds to the evidence insiders may have committed securities fraud, is also evidence of something obvious: he, along with every other insider except the CEO, does not want to hold shares of AMRN, and would rather at every opportunity trade them in for cash now. Why? Why dump constantly? They must believe the risk in holding shares outweighs the potential reward from their appreciation in value.
We are now approaching $90 million worth of shares dumped by insiders since the AHA meeting in Nov. No one on the planet knows as much about (a) the content of previous discussions with potential acquirers and licensees and their misgivings/apprehensions about the chance of getting label expansion and the security of the IP; (b) the content of the ongoing patent litigation cases, and the confidence/lack thereof their attorneys have in a win (notice the CEO will only sheepishly say “we like our IP,” okay well you can “like” anything, but it doesn’t make it good or strong or likely to hold up in court); (c) what their regulatory expert consultant(s) have been advising them on how the process has been going with FDA so far, what it means and doesn’t mean, and the impact a Citizen Petition may have, and the potential for FDA to place a clinical hold on EVAPORATE or not. And, relatedly, the advantages in undertaking a massive secondary ($300mm - $400mm+) before negative catalysts can significantly, perhaps irrevocably, affect the share price. And that if they do not raise very soon, it could prove foolish.
This upcoming week we are entering the most likely window of time in which FDA will communicate to the applicant (Amarin) the content of their internal mid-cycle review (goal: within 2-weeks after it is held), and with it relay to them their decision on whether or not to hold an AdComm meeting, and if they will, what date will be set. The applicant will then publicly report what that date is before it has a chance to appear on the web. July 8th - 12th is the most likely window now in which we will be told of an AC meeting and the date. Somewhat later is of course also possible. But if the 22nd comes and goes without any mention of an AC meeting, then at that point there probably won’t be one, and you may breathe a temporary sigh of relief. Why a sigh of relief? Because by far and away the most common reason to hold an AC meeting is because “there are significant questions as to the safety and/or efficacy of the drug.” In fact, if a drug is approved without an AC meeting, the FDA makes a note of just that in its letter to the sponsor. For example:
Will AMRN bulls be more willing to concede the recent insider sales are evidence of securities fraud if a massive secondary comes soon? That would be the "icing on the cake", would it not? Or perhaps some negative communication with FDA relayed to the public?
The CEO has been very careful, and has conducted himself and his handling of trades outstandingly -but the other insiders, well.
Please do not forget to speak with a registered investment advisor if you are overweight AMRN securities, and if a sharp and sudden downturn of the stock would be destructive to you and your family's well-being. You could be wrong about AMRN, couldn't you? If the loss would only affect you, okay, but wouldn't loved ones also be harmed? There are also numerous ways to hedge your position to protect it against loss, if you just cannot bring yourself to reduce your exposure to AMRN, such as purchasing Jan 2021 puts. A registered investment advisor can look at how much you have at risk vs your NPV and guide you well. You may be surprised at how much they can help you expose capital to high reward scenarios while still minimizing your risk substantially. Please do seek one out. We do not want to see anyone, and any one's families, get hurt.
Happy 4th to all.
Kind Regards,
-MRC Team
Avii77,
The attempt at and execution of fraud are not always the same. These sales were set up in advance based on 10b5-1 plans, but the majority of such plans (the stipulations of which are entirely up to the company that imposes them) allow insiders to sell securities in a minimum window of 30 days or less. Some as little as two weeks. Unless the SEC Form-4 states specifically, you cannot know when exactly the insiders set up the transaction and date they intended it to execute (which isn't always exact either -there is some headway in the execution).
The press release came early morning 7/2. The transactions that occurred from 7/1 - 7/3 are as follows:
Joseph Kennedy: exercised and sold $610,308 worth of securities on 7/1
Michael Kalb: exercised and sold $409,827 worth of securities on 7/1
Aaron Berg: exercised and sold $2,745,756 worth of securities on 7/2 and 7/3.
These three individuals may very well have been pressing hard for the release of information by 7/1, but it came a day late. Only a thorough probe by SEC and DOJ can, along with witness testimony, be able to ascertain all details. But it is by all appearances illegal insider trading.
We are not interested in contacting the SEC or DOJ to start an investigation, although we think other persons may. There is certainly grounds for a thorough probe here. Our goal is to advocate for our research and seek to help in whatever way we can the FDA to make a decision that will benefit all US citizens.
Regards,
-MRC
This is brazen securities fraud via insider trading. And it isn’t the first time.
Suspicious, one-month early increased revenue guidance? Doubling of sales reps? “Assuming” sNDA approval? A positive sign on the balance sheet? Was this really an early gift to AMRN bulls, or does management have other reasons for dropping this premature “optics” package?
We think it was a prudent, shrewd move. In our view, Amarin insiders have carefully weighed the risks and what the pending communications with FDA may mean for their ability to go to capital markets and raise significant funds. Right now they have nothing but positive to say. Within two weeks there could be an AdComm announcement, and/or FDA may request additional data, which would ultimately extend the PDUFA date. And there is also the imminent threat that FDA will issue a clinical hold on EVAPORATE.
Thus, the premature rush to get good news out, and we think probably raise cash soon.
Here is yet another example where the market, at least in the short term, is rather oblivious.
Regards,
-MRC
Citizen Petition Acknowledged as Received by FDA
https://www.regulations.gov/document?D=FDA-2019-P-3156-0001
The petition contains all of sections 1.1 - 1.13 and sect 3.3 of our greater 250-page report, entitled “Identification and Analysis of Amarin Corp.’s Harbingers of Bankruptcy”:
https://medicalresearchcollaborative.com/reports?product_id=51
You may submit a comment regarding the content of our petition to the FDA by following the first of the two links above and selecting the “Comment Now” button. We recommend thoroughly reading the 82-page petition first, however, so that you may make a more informed comment.
Regards,
-MRC Team
We obviously believe that funds actively invested in AMRN are relying on a faulty risk-to-return model, which is itself based on insufficient due diligence/incorrect conclusions.
It's not for a lack of trying; funds hire trusted consultants, and over time have developed relationships with the same, leaning on a track record that has proven reliable (i.e. 'consultants "Dr. John" and "Dr. Mike" have helped guide our investments in healthcare companies A - G, and we are up X% in these active/closed out plays. Both Drs. are well-published cardiologists and like REDUCE-IT, think the sNDA is a shoe-in: >95% chance of approval by end of Sept; we can reassess patent portfolio after sNDA approval,' etc.).
Some of the ways in which we think funds have gone wrong here is an insufficient weight given to regulatory thinking and precedent (i.e. what is uninterpretable is not approvable; likelihood of requests for additional data; likelihood of AdComm; potential for clinical hold on related trial), and an over-reliance on mainstream cardiologists' view of changes in LDL-C, including older paradigms no longer regarded as sound, though still adhered to by many (ex. 1 mmol/L reduction = ~22% RRR).
It will be interesting to see how this plays out, and whose research was more comprehensive/accurate: ours, or theirs. But one thing is for sure--if they are wrong, they will go on investing for their clients, brushing off but learning from the experience. Meanwhile, many retail bulls will be financially ruined, particularly because they have too much exposure to AMRN with no net (hedge).
Good luck to all, and don't forget to at least inquire with a registered investment advisor about hedging strategies if you are planning on staying long from this point forward. For example, buying Jan 2021 puts with 10-15% of your position, etc. Especially if you have well over 30% of your NPV invested in this one company (which flies in the face of 100 years of established investment theory). We believe the risks far outweigh the potential rewards here, in particular between now and September, and then again between the sNDA outcome and the patent litigation outcome in late Jan/early Feb.
You may give up a modest appreciation in share price by sitting it out or acquiring puts, but that is far outweighed by what the potential negative catalysts could do to your retirement/trading account, including (a) an Advisory Committee meeting announcement sometime over the next two weeks; (b) an announcement that the PDUFA date has been extended by 3 months, due to the request for and submission of additional data, causing a major amendment to the sNDA; and/or (c) an announcement that the EVAPORATE trial, also sponsored by Amarin Corp., has been placed on clinical hold. Both (b) and (c) in particular would cause a sharp sell-off of the stock, and could blindside you well before Sept 28th.
One example of hedging an overweight long position in AMRN would be securing Jan 2021 puts (ex. 10% of $100,000 worth of shares, or $10K used to purchase $7 and $10 put strikes would yield 500% return on stock trading below $1 by then at current bid prices, protecting some 60% of the $100K AMRN stock position against loss). This could certainly help retail investors with under $2 mil invested in AMRN.
So, please do seek out the services of a registered investment advisor to help weigh the risk/reward here and assist with hedging strategies. Unless, of course, you have never been sure of a thing and been wrong before.
Kind Regards,
-MRC Team