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TO ALL: this is our last message on investorshub, as we have decided not to renew our IRP membership here. We are content to have created a backlog of posts that may be examined in the future.
Good luck to all, and we hope you seek the advice of a registered investment advisor on your exposure to risk in AMRN, and on hedging strategies.
ggwpq,
You’re right—that would certainly make an Advisory Committee (AC) meeting being held to discuss the Vascepa efficacy supplement a bad omen, signifying that FDA may consider the purported efficacy of Vacsepa from the REDUCE-IT study as dubious.
Regards,
-MRC
Remember Repatha, a far less safe and efficacious CVD drug with much more trial patient data, was approved in 6-month time without AC. Vascepa will be a far easier and quicker decision for the FDA. -ggwpq
Can you imagine if the ICER report mentions the potential for REDUCE-IT results to be inflated, and perhaps even carries that somehow into QALY calcs? Could this be a similar set up to pre-AHA, where the stock price was inflated and pumped up on good expectations only? This time it anticipates no AdComm and fabulous ICER report, both currently priced in. What happens if it is let down?
This may prove to be a very interesting month for AMRN.
-MRC
Right now we give sNDA approval about a 40% - 50% chance. However, that is if no AdComm. If an AdComm is announced, that drops to ~25% - 30%, especially if the stated "Agenda" on FDA.gov regards the efficacy/trial design/placebo choice. And then if the AdComm vote comes back majority "no," chance of approval falls to less than 10%.
Still, in any scenario, it could of course happen. Then we see a loss in the consolidated patent litigation for Amarin being >85%.
If they do not get sNDA approval (either in late Sept or late Dec if PDUFA is at some point extended 3-months), and are issued a CRL instead, perhaps requiring DDI studies to exonerate mineral oil in the perceived malabsorption of cardiac medications before granting approval, as our first Citizen Petition requests, then the stock will likely fall below $5, and then continue to below $2. If they get approval, but then lose the patent litigation case, stock will probably also fall below $5, and continue lower to <$2. If they lose both, it will certainly fall below $1, and it won't be long (maybe 12 - 18 months) after that that they are delisted (relegated to OTCBB), and then not too long after that, they will likely cease to be a going concern.
All this from the lofty current market cap of $7.2 billion. Amazing disconnect the market is showing for this ticker.
Regards,
-MRC
In case anyone is wondering, NO, we very much do NOT want to see retail investors lose money in AMRN. Absolutely not. We really do hope they have asked the advice of a registered investment advisor who can examine their personal situation (like, say, having >80% of all assets--home equity included--tied up in AMRN stock) and help them mitigate risk here, which may be as simple as selling just 15% of their AMRN long shares position and buying $14 strike Jan 2020 puts with it.
It bothers us that while management are running away with over $90 million in insider sales since AHA in November, clearly spooked by something(s), they are out of the other side of their mouth promulgating a story that has gotten retail investors ever-deeper into AMRN. And we are sure a very large portion of these retail investors cannot at all afford a 50%-80% loss of their AMRN long position, should the negative catalysts we see on the immediate-to-medium-term horizon come to fruition.
No one actually has to get hurt here if they have hedged appropriately. Please consider talking with an advisor about hedging/risk. Do it for yourself and your loved ones.
Kind Regards,
-MRC
rafunrafun,
Why would you conclude "the time for an AdCom has expired" when the FDA specifically states in guidance the following:
-mid-cycle review for Priority Review apps: ~3 months into review timeline
-mid-cycle communication: within 2-weeks of mid-cycle review
and further states that one of the purposes of the mid-cycle communication is to tell the applicant of finalized plans to hold an AC meeting or not, and if plans to hold one, communicate the date (and also tell them when that will go live on FDA.gov).
As HDGabor pointed out, the CEO stated that the mid-cycle review occurred--or he was informed it was planned to occur--on June 28th. Two weeks from 6/28 is 7/12, or tomorrow. And knowing how FDA usually handles timelines, that will probably mean the mid-cycle communication will occur exactly on 7/12, or on 7/14, though it could be today, and could even be somewhat later than 7/14. These are "goals," not guarantees.
The mid-cycle comm is a "communication," meaning they actually talk, usually on the phone (CC). The applicant can and should ask questions. Although it's highly likely that FDA will tell them "no current plans to hold an AC meeting" if there are no current plans to, the applicant (Amarin) can and very probably will outright ask them if not given an answer, and will (as promised) report the answer by PR. And, of course, if there will be one, FDA will communicate that directly (and the date).
So, in actuality, the most likely time you will hear of the content of the mid-cycle comm, including on whether there will be an AdComm and the date, is after hours tomorrow, or Monday morning, with somewhat less probability after hours today, and less probability each day after the 14th. The "window" is not closed, it is not "expiring," and if anything we've finally come into the most likely time an AC meeting and the date will be reported regarding AMRN.
If/when the AC meeting comes, keep an eye out for the stated "Agenda."
Ex.:
Agenda
The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.
Your TA will always lag behind high-frequency trading algos (quant funds). It is no longer useful in today's age. Although it may at times randomly steer you right, you will on average do better simply allocating monies to an index fund, or relying on exhaustive due diligence in placing your trades, as all high-return non-quant hedge funds do. Your style is a throw-back to the 90s/early 2000s, and is irrelevant.
The statement: "AMRN will never see another 52-week high ever again," which we think is highly probable (perhaps 70 - 85% likely), is based solely on our exhaustive research. Research that well-established firms are willing to pay for.
If you continue to follow your dated TA you will almost certainly lag market benchmarks. Only retail investors take any of it seriously.
That brings up the one way you can consistently make money off of TA, and that is by selling its teachings to retail, a large percentage of whom are unsophisticated enough to think it works.
Kind Regards,
-MRC
There will never be a new 52-week high in AMRN ever again.
Let's see if that ages well.
-MRC
No, that’s not correct. The guidance is also quite clear on this.
...Solicited amendments [requested by FDA; i.e. blood pressure data from REDUCE-IT?] are usually reviewed during the current cycle provided they are received early enough. The RPM processes the amendment and distributes it to the review team.
Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date.
Yes, but, plans can change during an application review. We agree it’s most likely to have occurred, but also possible it was deferred as per our last post.
Regards,
-MRC
Looks like you missed it: mid-cycle review meeting WAS on 6/28 … the FDA could not "held off on the mid-cycle review altogether" … since it is history now. -HDGabor
Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date. If the planned date for discussion of labeling and PMRs/PMCs is changed, the RPM will notify the applicant. (See MAPP 6010.8)
For PDUFA V [and VI] “Program” applications [including current Vascepa sNDA], the new planned review timeline will include a new planned date for the internal mid-cycle review meeting, if appropriate, depending on when during the course of review the major amendment(s) is accepted for review. All other milestones are adjusted to the new goal dat
HDGabor,
We don’t know of a case where the FDA never communicated to the sponsor of a priority review application whether they plan to hold an AC meeting or not. In every example we are aware of, it is either communicated by day-74 letter that “there are no current plans to hold an AC meeting,” or they mention preliminary plans to hold one then, or wait and fully confirm the AC meeting and date at mid-cycle communication CC (which comes “within 14-days after internal mid-cycle review”). We are also unaware of any cases in which FDA waits until mid-cycle comm to tell sponsor or confirm sponsor’s request for clarification that there will not be an AC meeting. Suppose it could happen, but unlikely. Thus, our >80% chance we are told by Amarin there will be an AC meeting and the date of the meeting, and soon (next week the latest).
The only possible deviation to this we can see is if the FDA held off on the mid-cycle review altogether (see section of guidance we posted), knowing they would be sending Amarin an Extension Letter, pushing the PDUFA date back 3-months, and with it the planned mid-cycle review date. They could deliver, along with this Letter, notice of preliminary plans or definite plans to hold an AC meeting, and if plans are definite also a date. Or, in this case (PDUFA extended), they can also wait until “within two weeks” after the new mid-cycle review date, which date would be about 4.5 months into the new 9-month total review, or mid Aug, to let Amarin know on AC meeting plans at that mid-cycle communication CC, which would then be in late Aug.
It is certainly a swirling web of info: if this, then that, and if that, then that and that, but no longer that or this... These reviews are complex.
On the ANCHOR biomarker data submitted with MARINE, FDA confirmed they didn’t even look at its efficacy data but only safety data during MARINE review. Reason being they did not have full ANCHOR dataset, and chose not to infer from study report only, even though it did contain top line biomarker data (see our “Why Didn’t the DMC Recommend the REDUCE-IT Trial be Halted?” section of our first CP). Prudent choice, in our view. Didn’t even touch it.
On why an AdComm, these are the three specific reasons given by FDA (except for all NCEs and BLAs, etc):
A review division may need AC input, for example, when: 1) the clinical trial design used novel clinical or surrogate endpoints; 2) the application raises significant issues on the safety and/or effectiveness of the drug or biologic; or 3) the application raises significant public health questions on the role of the drug or biologic in the diagnosis, cure, mitigation, treatment, or prevention of a disease. —FDA
HDGabor,
Interesting thesis. Considered the ICER report but the content would in our view be predictable, thus not significantly market moving. Similar to predictable AHA data on secondary eps, or follow-up second event data at ACC (~30% RRR etc).
And of course, we differ on what we view as likelihood of AC meeting. Also consider the recent move up as a possible market reaction that incorrectly assessed the “AdCom” window as closing and an announcement less likely thereafter. Adam Feuerstein added to this misunderstanding with a follow-up article expressing incorrect assertions of FDA guidance (“60 day notice” doesn’t exist, etc). The PR was in our view interpreted to mean an even greater possibility there wouldn’t be an AC meeting now. We feel that assisted the propulsion over $23, though was misguided.
I guess we will see. Not long now.
Good luck to you.
-MRC
Sts,
Extending the PDUFA date due to major amendment caused by solicited (requested by FDA) additional data submission is very possible here, either very soon, or closer to currently planned PDUFA date. However, the fact that FDA’s goal is to convene AC meeting no later than 6-weeks before the planned PDUFA date for priority review apps doesn’t mean it is at all too late for FDA to inform Amarin there will be one. In fact, a very common time to tell the applicant there will be an AC meeting, and the scheduled date, occurs two weeks after mid-cycle review, or about July 12th for Amarin. Somewhat later or earlier is of course quite possible.
Why anyone would want to sit passively in a long position here is beyond us. Especially after this run up. All you are possibly missing by selling until early-mid September are negative catalysts. In fact, the only positions that make sense until then are short leveraged.
Regards,
-MRC
Hayward,
That “most likely” range was based on the likelihood they would receive communication from FDA in the day-74 letter regarding preliminary plans to hold AC meeting or not, plus some possibility they would be told later during the mid-cycle communication (held by CC within 14-days after mid-cycle review). It is standard practice to at least be told by FDA they are not currently planning an AC meeting in the day-74 letter if they are not planning on one. In this case, FDA did not communicate that they were or were not yet currently planning on holding an AC meeting in the day-74 letter. That became definitely known to us on June 25th as per the CEO’s public remarks. That shifted the most likely window to 14-days from mid cycle review only. That would be up to or somewhat after July 12th.
To sum it up, the day-74 letter is when you normally hear of preliminary plans to hold or not hold an AC meeting (can be sooner for priority review apps). Clearly FDA was still undecided by day 74, or perhaps contingent upon reviewing new data submitted by Amarin (solicited) that might be cause for an Extension Letter instead. That would give the review team more time to decide ultimately what to do by the planned mid-cycle review and subsequent communication. Lots of moving parts. The key for FDA is to maintain flexibility during their review. If they’re not sure of something they will dig deeper until they are sure enough to act/request/communicate.
So:
-PR from Amarin that an AdComm meeting is planned and the date, or that one is not currently being planned by FDA, will come this week or next. If not:
-They may have been sent an Extension Letter instead, and will have to report a 3-month push back to the PDUFA date, and possibly also mid-cycle review. News on AdComm could be sent with the Extension Letter, or FDA can wait until the now pushed back mid-cycle review to decide definitively.
Likely drop below $19 on AC meeting announcement, and probable drop below $17 on PDUFA extension announcement. Worse if both announced.
We outline these overhangs for AMRN here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149837081
Good luck to you.
-MRC
Hi bogatie,
A great question. If you examine the effects of different doses of statins you’ll notice that between nothing at all and low dose—let’s use atorvastatin 10 mg as example—a marked reduction in LDL-C occurs. About 35% in our example. From there, the net reduction is greatly depreciated with every doubling of dose. The one study we cite shows about an approximate 5% further absolute reduction in LDL-C for every doubling of statin dose. So, 20 mg atorvastatin will cause about a 40% overall reduction from baseline, 40mg will result in about 45%, and 80 mg will result in about 50%. Thus a 15% further absolute reduction in LDL-C results from 8-fold the dose. Do you see the problem with the observed 10%-11% retrace from baseline at years one and two in particular in mineral oil placebo group? What might that signify? A multi-fold reduction in the absorption of statin dose.
Notice that in the TNT study both groups began on 10 mg atorvastatin. Then, one group was given 80 mg and experienced a further 14% absolute reduction in LDL-C. That was from 8-fold the dose. However, the RRR of the 80 mg group vs 10 mg dose group by end of study was 22%.
We highlight the fact that LDL-C began returning during the last years of the study as further evidence—not conclusive, but evidence—that statins were being attenuated, and with dropouts being common late in the study such a phenomenon would be expected. For instance as in ODYSSEY, etc.
Regards,
-MRC
The nearest potential negative catalysts:
There are a few key points in time in which the FDA will inform an applicant whether it plans to hold an AdComm meeting or not. The most common being the day-74 letter. And so we expected it to reveal to Amarin FDA's preliminary plans to hold one or not. When the CEO emphasized as late as June 25th that they have been told absolutely nothing either way about it, then it became clear the FDA was waiting until the mid-cycle internal review to discuss and finalize plans for an AC meeting (meaning one is likely), and planned to convey that to the sponsor in their mid-cycle communication (within two weeks after review). Otherwise, in their day-74 letter they would have very succinctly stated to Amarin, "FDA does not currently plan to convene an Advisory Committee meeting."
The market, and numerous posters/investors do not seem to realize the events up until now actually make the possibility of an AC meeting much more likely than not. We've read 95%, 90%, 99% etc chance of no AdComm. In our view, it is probably more like >80% chance there will be one now.
So the AC meeting announcement is one catalyst. A negative catalyst if it occurs because by far and away the most common reason for FDA to request one is:
There are significant issues regarding safety and/or effectiveness of the drug or biologic. --FDA
...Solicited amendments [requested by FDA; i.e. blood pressure data from REDUCE-IT?] are usually reviewed during the current cycle provided they are received early enough. The RPM processes the amendment and distributes it to the review team.
Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date. If the planned date for discussion of labeling and PMRs/PMCs is changed, the RPM will notify the applicant. (See MAPP 6010.8)
For PDUFA V [and VI] “Program” applications [including current Vascepa sNDA], the new planned review timeline will include a new planned date for the internal mid-cycle review meeting, if appropriate, depending on when during the course of review the major amendment(s) is accepted for review. All other milestones are adjusted to the new goal date
Yes, the Titanic looked very good on paper. So did many other engineering failures.
Math will help lead to a correct placement or materials to handle loads etc., and that will usually be applicable in reality, especially when overloads are factored in (margins of error). That doesn't mean math exactly reflects reality. That is why margins of error exist.
If mathematics cannot exactly replicate reality, then our musings on whether or not the sNDA for Vascepa is approved by FDA without a hitch that much less so. The variables are exceedingly numerous, and how many unaccounted for in this or that thesis?
All that is spoken or deduced can only ever be an approximation. But the more detailed the evidence and the more numerous the data points used to advocate a given position, the better aligned that position with the true odds inherent in the position. Our analysis, which is far more extensive than any available on AMRN, especially the puddle-water deep musings of buyside, portends a far higher likelihood the negative catalysts possible and that are approaching come to fruition than the $7B+ market cap in AMRN gives these credit for.
Regards,
-MRC
No, but we will tell you that math is a fantasy that only exists on paper. Reality is full of jagged edges and things that are indivisible but can only be described as separate. For example, what is one share of AMRN? Is it really one share? How do we quantify one share? Only in its comparison with another share. That is circular logic. And at any given point in time the value of the share is not the same as a previous point in time, and there is an ever-shifting overhang of potential dilution further separating what defines "one share," therefore what defines one share is in flux.
One orange is not ever the same as another orange. So what is "one orange?" It's a trick of language to help us discuss reality, but isn't quite accurate. One US dollar at time point A is not one US dollar at time point B. Everything is an approximate. Math is a lie.
Regards,
-MRC
Jesselivermore,
Correct, that is why trading securities, including of course AMRN, should be considered a zero-sum game. If you don't think it is, perhaps you do not understand the rules.
https://www.vanguard.co.uk/documents/adv/literature/zero-sum-game-2013.pdf
Regards,
-MRC
Should everything they ever say about a healthcare play be counted as wrong because they made many "wrong" calls before? -MRC
NCE covering Vascepa doesn't expire in 2021. It expired in 2017. If they were granted 3-year exclusivity (and so not NCE exclusivity), they would have lost to ANDA filers nearly two years ago. Or won. But, most likely, lost.
Regards,
-MRC
rafunrafun,
Your analogies belie the bias inherent in your argument. They are not at all the same.
If an individual sees reason to believe an outcome has a certain chance of occurring that causes the risk:return of an investment in that outcome to be skewed to the negative (such as getting $0.40 but losing $0.60 for every call on a coin flip), and for that reason believes the best ROI to be a short sale on the investment (being the one holding the $0.60 end above), but ultimately is wrong about a particular outcome (one isolated coin flip), then were they "wrong" in taking the short sale position above? No, they were right, regardless of outcome.
And even if they were wrong on the risk:return--say they believed they would be on the $0.60 end but were really on the $0.40 end--it does not by that fact invalidate every call they ever make from that day forward.
We've pointed out to you before that Baker Bros, who has an enormous stake in AMRN, has made "wrong" calls 55% of the time. Since inception, they have lagged behind every healthcare ETF/index fund out there, which have all handily beat the S&P in the same time frame, while they barely have. Are they good? Are they bad? Is the timeframe/number of calls too small to confidently conclude one way or another? Should everything they ever say about a healthcare play be counted as wrong because they made many "wrong" calls before?
So you are quite mistaken. But fully entitled to continue in your faulty logic.
Regards,
-MRC
First of all you did not provide any evidence … just your view / interpretation of available info.
The counter-arguments will be the real evidences as:
- no AdCom
- FDA approval
- settlement with ANDAs or the favorable court decision
If all these in the bags: will you think you were wrong or it will means everybody were wrong and ignored the "evidences" provided by you? ... -HDGabor
ev·i·dence
/'ev?d?ns/
noun
noun: evidence
1. the available body of facts or information indicating whether a belief or proposition is true or valid.
Shorts better hope the FDA doesn't formally notify AMRN of no AdCom -Tastytheelf
biowreck,
The sad reality is, if Baker Bros Advisors are wrong on their AMRN call, about 3-4% of their AUM goes up in smoke. A significant ding, no doubt. But what do you think the average NPV loss for retail AMRN bulls would be? 3-4% like Baker Bros, or a little higher?
Good luck to you.
-MRC
rafunrafun,
This is yet another logical fallacy. If individual A. makes argument B. based on evidence C., and argument B. is later proven wrong, and subsequently individual A. makes argument D. based on evidence E., that remains as yet unproven, it is illogical to conclude that argument D., which relies on evidence E., is faulty, because argument B. was proven wrong. Further, it is a compounded error to then assert all arguments by individual A. are wrong because (s)he made argument B., which was proven wrong, ergo all subsequent arguments by individual A. are de facto wrong.
Once again, you must present counter-evidence to our current arguments regarding Amarin Corp., including our evidence the REDUCE-IT results are confounded, and FDA will likely not approve the efficacy supplement without supplementary data proving mineral oil has no effect on multiple cardiac medications, and also our evidence that the patents covering Vascepa are all either invalidated for lacking novelty and/or for obviousness, or are otherwise not infringed by ANDA filers. You have not even attempted in the slightest to do so. That is your prerogative, but it should be pointed out.
Regards,
-MRC
Have any of you thought about making money shorting AMRN? The goal of investing in AMRN is to show a positive ROI, right? You feel that AMRN is an excellent long play, that it will be acquired probably for multiples of its current pps. That is certainly a good basis for a long investment.
But what can happen before the sNDA is approved (if it is)? An AC meeting announcement would most probably cause a sell-off, and an announcement one way or the other is coming soon. We think the behavior of the FDA towards Amarin, as revealed by the CEO at multiple conferences, portends that there will likely be an AC meeting (>80% likely). There is this smaller but ever-present risk that EVAPORATE will be placed on clinical hold, and if that occurs the stock price will fall precipitously, perhaps to <$10. The AC meeting itself could expose unfavorable briefing docs and return an unfavorable result. And/or, within one month to even just before a decision on 9/28 there could be a PR from Amarin that FDA had previously requested information that Amarin submitted and as a result of that submission considered it a major amendment to the sNDA, and thus is extending the PUFA date to Dec 28. There could still be no settlement by mid Dec in patent cases, causing the likelihood of bench trial to be very high (ANDA filers win these overwhelming majority of time).
OR, it's clear sailing to late Sept.
But what is the risk:reward here until late Sept? In our view, the situation Amarin currently finds itself in is extremely skewed to the "risk" side. The market is behaving as if it is 1:5, when it is probably more like 5:1.
Why not only hold puts? And wait until we at least get to mid Sept before deciding to go long again? Let's look at an example:
-Your cost basis in AMRN is $11/share.
-You sell all shares of AMRN at $22, locking in a 100% gain.
-You purchase $14, $15, and $16 strike puts, expiring Jan 2020, with 15% of your above total sold position (15% of basis+profit)
Then two things happen:
-You lose 70% of put value when mid Sept comes and stock is still >$20.
-At this point you still hold those puts as hedge, but go long with the 85% in cash still sitting on the sidelines, losing about 10% overall but avoiding any heavy losses.
or
-The stock suffers from the above risks coming to fruition, and your put position is currently up 300% -- equivalent to a 45% gain in your long share position.
-You still like your chances despite negative info in briefing docs and negative AdComm vote, so go long your 85% cash sitting on the sidelines, buying at $9 and getting nearly twice the shares you sold from $22. You maintain your put positions as hedge in case PDUFA extended and/or CRL comes.
-OR, because of all of the negative catalysts, increase your put position--OR close it out and lock in 45% gain on top of your already 100% gain.
It doesn't seem logical at all to do anything other than sell all shares and buy puts here. You can always adjust later after the risks pass by.
However, this is not investment advice, and is for informational purposes only; you should seek the advice of a registered investment advisor before doing any of the above.
Regards,
-MRC
Tastytheelf,
Just for fun (yours in italics):
- EPA doesn't do anything [we never stated this]
- It causes liver damage [evidence suggests that fatty acid ethyl esters, such as Vascepa, after long term use may cause organ damage. We provide evidence of this here: https://www.regulations.gov/document?D=FDA-2019-P-3156-0001 ]
- It does work, but it's just a dietary supplement [it works to lower triglyceride levels, and lower some other markers. It may reduce the risk of ASCVD at 4 g/d, but because the results of REDUCE-IT appear to be confounded, DDI studies would at the least be needed to exonerate mineral oil in the perceived malabsorption of cardiac medications, and/or a new CVOT with an inert placebo conducted. And yes, it's just a dietary supplement.]
- It does work, but DPA is better [we never stated this]
- It does work, but the patents are no good [if by "it does work" you mean at lowering TG and some other markers, yes we advocated that; if by "it does work" you mean reduce risk of ASCVD, see point above; but on the patents, yes we argue they are "no good"]
- It does and doesn't work literally at the same time [that may be true. See points above]
Kind Regards,
-MRC
rafunrafun,
Yet another logical fallacy is presented.
We say, "the strength of the evidence presented should make or break an argument, not the qualifications of the one presenting the argument."
You respond, "qualifications are necessary to determine employment."
Can you see which fallacy you committed? Review:
https://writingcenter.unc.edu/tips-and-tools/fallacies/
When we say "REDUCE-IT appears confounded, and the RRR materially inflated, because _________." The blank is our evidence. If you want to disprove our argument, you must confront the quality of our evidence, not run background checks on us.
Our evidence is presented for all to see here:
https://www.regulations.gov/document?D=FDA-2019-P-3156-0001
Regards,
-MRC
dmlcento,
Thank you for an excellent example:
If you tell me that right now it is Thursday in St. Louis, MO, that is incorrect and you can argue all day that it is correct, but that doesn't make it so. Right now it is Wednesday in St. Louis, MO. End of argument. -dmlcento
SocialBoom,
We have actually spent little to no time trying to prove the same Steven Giardino that posted on ihub previously about his views on REDUCE-IT failing and his arguments that were negative on NWBO and their tech is not a member of MRC. We have spent almost all of our energy on the argument itself, including what our research has revealed to us to be the confounded nature of the REDUCE-IT trial, Amarin's frivolous IP covering Vascepa and its uses, and the out of synch risk:reward compared with current market value. It is AMRN longs that are seeking to slide around and look past these arguments that are focusing on who is making the argument. That is of course a very common logical fallacy, that those who want AMRN to "make them rich" unconsciously commit to help enable them to ignore the content of our research.
Regards,
-MRC
ggwpg,
No, there is no burden on us at all. We will occasionally attempt to redirect AMRN longs' focus to what actually matters--the content of our arguments themselves. But we understand if they cannot find the ability within them to do so.
Regards,
-MRC
rafunrafun,
Why do you think you are trying so hard to figure out and tell everyone who the members of MRC are? In the end, does it help or hurt a long thesis in AMRN? Does it prove or disprove any of our arguments on Amarin and REDUCE-IT?
If a student that is not a PhD yet writes a paper on neuroscience (this is common from PhD students), should the content of the paper be disregarded because the student has not yet earned a PhD? Some of the best research papers in the world were written by students with no accolades as of yet.
We hope you can see how misdirected and what a waste of time your pursuit is. It does nothing to speak to our actual arguments on REDUCE-IT and Amarin Corp. And FDA, for one, will seriously weigh everything in our three CPs, regardless of who they think we may or may not be. In fact, they do not care at all the qualifications of those that submitted it. They are only concerned with the content itself. We would advise AMRN longs to do the same. But if you just cannot help yourselves, well then that is too bad for you.
Regards,
-MRC
dmlcento,
You have just committed another logical fallacy here (they are often connected in a string of fallacies). Here the fallacy is known as false dichotomy.
It is easy to commit these fallacies, and they are quite unconscious. It is hard work to remain objective about a matter we very much want to be true, such as, that REDUCE-IT is not materially confounded, that FDA will approve the sNDA on or before Sept 28, that there will be no AdComm because there are no "significant safety and/or efficacy questions" on REDUCE-IT, that their IP is a "rock solid fortress" that is impenetrable by ANDA filers, and they will likely settle with terms similar to TEVA, etc. etc.
Bias is powerful. Try telling someone in love with a person that is abusive to them that that person is abusive and the relationship should be ended. Watch them defend the person irrationally. There are many, many examples of denial, delusion, and bias. And it is very apparent amongst stock market participants. Because if they are wrong, they will lose money; if they are right, they will "get rich." Therefore, compulsively, they will attack counter-arguments to their "get rich" beliefs. Such as, "AMRN will be bought out for $199."
This is the primary reason we have instituted the company policy that no member of MRC may actively trade individual tickers.
Regards,
-MRC
It is up to you to interpret it however you wish. Without conclusive evidence it will always be conjecture.
The address of MRC is listed on our webpage. You may send us a postcard and we will receive it.
When considering an argument that is favorable to a long-thesis in AMRN, it seems that long investors are biased to accept it without much consternation. However, when considering an argument that is unfavorable to a long-thesis in AMRN, it seem investors are biased against accepting it, and rather than debate it, slide past it and seek to denigrate the individual making the argument. Why do you suppose that is? It's a very common logical fallacy:
https://writingcenter.unc.edu/tips-and-tools/fallacies/
Please review these fallacies and check to see if you are committing one or more of them in your debating on all things AMRN.
Regards,
-MRC
The name of the President and CEO of MRC is Steven Giardino. However, he does not reside in New York, never had, and never was a contractor or tradesman. That poster states that he is a Steven Giardino that is a tradesman living in New York. And so, you can see that they appear to be two different people.
rafunrafun,
There are a few key points in time in which the FDA will inform an applicant whether it plans to hold an AC meeting or not. The most common being the day-74 letter. And so we expected it to reveal to Amarin FDA's preliminary plans to hold one or not. When the CEO emphasized as late as June 25th that they have been told absolutely nothing either way about it, then it became clear the FDA was waiting until the mid-cycle internal review to discuss and finalize plans for an AC meeting (meaning one is likely), and planned to convey that to the sponsor in their mid-cycle communication (within two weeks after review). Otherwise, in their day-74 letter they would have very succinctly stated to Amarin, "FDA does not currently plan to convene an Advisory Committee meeting." The CEO really should have said nothing about it.
The market, and numerous posters/investors do not realize the events up until now actually make the possibility of an AC meeting much more likely than not. We've read 95%, 90%, 99% etc chance of no AdComm. No, it is probably more like >80% chance there is one now.
Regards,
-MRC
Bolio,
No one affiliated with MRC is a tradesman. Although I did attempt a deck board repair last month. It went okay.
We can understand the pursuit to identify the members of MRC, and it is amusing at times the variety of individuals we are thought to be, but without the help of law enforcement and subpoena, it is almost certainly outside of your reach.
Our goal here is to share our research on Amarin Corp., and create a backlog to be reviewed later by other parties. Our research can be debated. You are quite free to read and critique/disprove anything in our 82-page citizen petition, or, if you have purchased access to it, our 250-page greater report, which includes an exhaustive analysis of the Vascepa IP and potential future market prospects (and limitations thereof).
Have a look at our CP that highlights the potentially confounded nature of the REDUCE-IT trial, and feel free to post your critique here afterwards (click on PDF):
https://www.regulations.gov/document?D=FDA-2019-P-3156-0001
Regards,
-MRC