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Happy Friday.
Currently the PPS is down 10% and the back-biting rats are back in force. The board has gotten very nasty and personal again.
I’ve been thinking about all the various discussion topics and have come to some conclusions of my own:
We really don’t know what game plans are being devised by management, and we can’t expect to know. We also don’t know what considerations the FDA is making with respect to Vascepa, and we never will. We also don’t know the extent that Vascepa will be accepted by the medical community.
Given all this uncertainty - the regulatory snafus, the less-than-stellar rollout of V, the balance sheet issues, there is great room for doubting the prospects of AMRN. And that is certainly reflected in the current stock price (down to $0.94 as I write this). However, there is still a GREAT DEAL of positive potential:
1) FDA could agree to an expanded label, especially since they seem to have painted themselves into a corner with their SPA decision. 2) Sales could begin to accelerate. KOWA’s involvement, further acceptance by insurers, more referrals based on positive patient results, etc. – all of these are potential drivers. 3) REDUCE-IT might produce excellent results. Not at all out of the question. 4) Additional CV-related studies – like the ones Zumantu frequently finds and posts – could eventually sway not just the FDA, but key organizations to give EPA the same kind of respect that statins have enjoyed. 5) Purified EPA will begin to gain traction in non-CVD treatments (off label prescriptions, primarily). 6) Unknown developments in knowledge about how EPA works and its potential benefits.
Given what we DON’T know, it’s easy to be down on this investment. But given what we DO know, in terms of potential upsides, I see no reason to sell off even at this level and take a huge loss. It may seem like the longs are dreaming, but I feel otherwise.
Having the best-in-class EPA drug is reason to stay the course, while the experts sort out where EPA belongs in the medical playbook. It’s not going away anytime soon, that’s for sure.
As you are fond of saying, "Who cares?"
AMRN may not be a direct target of algobots, but it's certainly being traded by them - what other explanation for ping-ponging 100 block shares back and forth all day long?
To which I add an observation from NASDAQ site -- just minutes ago there were over 30 trades of exactly 300 shares each. All in a row. I have no idea if this has any meaning, but the pattern makes me suspicious. Low level accumulation? Bots? Hmmm...
Zumantu - as a long term investor, I can't thank you enough for this kind of information. Keep up the great work!
Good to know, rafunrafun. I see that Levin also has about 7.7 million listeners a couple of recent books that have been best-sellers.
Notably his last book, "The Liberty Amendments" which specifically talks about subjecting Federal departments and bureaucratic regulations to review and re-authorization.
We might get better, quicker traction on a press release to him, informing him of the AMRN / EPA story.
Hmmm.
Update on Media Contacts (including "60 Minutes"):
Now that I'm back from a 4-day mini-retreat in the wine country (emphasis on WINE!), it's good to see the various comments and suggestions. Thanks for looking into 60 Minutes address, rafunrafun. I also like your post about Mark Levin. Perhaps we can perhaps send something his way, as well. Zumantu, I couldn’t agree more about the google approach for editing the press release(s). Sounds good.
May I respectfully suggest the following, updated plan?
1) Establish a google group for all the above. We’d need a moderator, I think. Also, perhaps a group name is in order – like “EPA Awareness Alliance.” (Yeah, I know it’s a not much better than “Teenage Mutant Ninja Turtles for EPA,” but the press release will need to identify the sender in some way.)
2) Tailor a press release that can be used for a variety of journalists/media.
3) Identify potential media contacts, and get contact information.
4) Send it out and see what happens.
I don’t see any real harm in this, and I think there’s potential benefit, even if only one or two media sources pick up on the story.
Who’s in? (And if we can keep this ball rolling, are there any potential Google moderators?)
SF Guy
Why are there only 9 testimonials on the EPADI website? I would think it would be much larger. Without more compelling comments from physicians and medical experts I think people would tend to disregard the comments section entirely.
Press Release Update 1
Obviously there is interest in releasing a press release to 60 Minutes, and various other investigative news organizations. So let’s keep moving forward. Here’s my current perspective:
1) We do not have to provide lots of medical and regulatory information in the press release. What we have to do is convince someone in investigative journalism that there’s a potential story there. In order to achieve that goal, the release has to be compelling, succinct, and presented by an expert or group of experts. That is my opinion, but I think I know how to do an effective press release, since my area of expertise is in marketing.
2) The press, based on their audience and journalistic mission, will decide what the “story” is about – we won’t. It could be about AMRN, it could be about the FDA, it could be about FDA/CDC. It could also be a highly positive piece about potential new life-saving drugs that are on the cusp of success (one of which is Vascepa). That decision is out of our hands.
3) Given the range of potential stories, there is likely some respectable editor/correspondent already working on some version of that story and would be interested in more information. So I am hopeful.
3) Should the press release result in inquiries, we should be ready and able to relay journalists to the best possible sources of information. Top of the list is EPADI. Other leading candidate would be researchers/professionals already familiar with either Vascepa or EPA in general. (Your ideas are especially welcome on this point.)
4) Our overall goal is not to hold the FDA’s feet to some fire – it is to expand public awareness of the value of getting Vascepa out to larger, more diverse patient populations. (If someone at FDA falls by the wayside as a result of collective efforts on behalf of Vascepa, so be it. It’s not what I’d call a victory for us.)
That said, we have time to do this outreach without unnecessary panic and anxiety. Let’s respect everyone’s various efforts. No matter who contacts outside news media sources, etc., it’s probably all good – there is no such thing as “bad press.”
JL, et al - Would you like to proceed along the lines I’ve outlined above?
"Sounds to me like you're describing the EPADI....."
sts66, very good point.
The EPADI certainly would be a good source for journalists, but we have to drive them to it. MarketWatch carried good PR for EPADI back in June, but as far as news cycles go, that was practically another era. Now the press has Ebola, elections, ISIS, all sorts of things in the immediate windshield.
Another press release to all major media might snag something. It's all I can hope for, in terms of press.
I feel if a press release came from a dedicated, concerned group of clinicians and practitioners I think it would be easier for editors to look further.
Based on your suggestion, perhaps we should just directly add the EPADI website address to the press release. I think we should also include personal contact information, so questions can be fielded in person, not just directed to a website.
Thank you, investorfreak69. There has been other positive feedback, so I'll get this out right now:
I strongly suggest that the press release come from a group of concerned parties, esp. those that transcend the investment nature of the story - that is, concerned medical professionals, government employees, and people with serious CV health issues. (Simply being an investor in AMRN does not lend urgency to the message.)
I feel the message will have much more potential impact with the support of medical professionals, in particular.
JL, et al - are you willing to lend your personal support to this effort?
If so, I would be willing to coordinate the initial effort, which includes adding information on the press release that gives media appropriate contacts for more information.
Thanks for the input. If others concur with the overall idea, let's do it. In the meantime, I suggest the letter come from either a physician or a group of physicians / medical practitioners. I am not a physician, I just put that language in the draft. This is essentially a press release - and that's what news agencies paw through to come up with story assignments for their editors to investigate. We don't have to over-educate these people, we just have to get them interested in following up to see if there's a story there. If they are interested, we can then share more detailed information with them - links, contacts, etc.
Here's how I would get media attention:
We are probably spending way too much time explaining science, and not getting to the reason a news program or newspaper would want to cover this story: it's about corruption in the pharma world, not about pharma in a corrupt world. Let's think about not trying to kill their enthusiasm with a lot of scientific background, but instead, do more or a "press release" that can be shared with not just "60 Minutes" or "Frontline" but also the NY Times, LA Times, Washington Post, etc...
Here's my rough draft...please comment!
Dear “60 Minutes” Editor:
Picture this…
You’re a small pharma company that has developed a new, best-in-class therapy for preventing cardiovascular disease – the number one killer in the US. This new therapy – clearly gaining acceptance in the medical community at large – is a potentially revolutionary new chemical derived from fish oil, and protected by dozens of long-term patents. (If fact it could be the “aspirin” of the 21st century, with all sorts of uses.)
Initial test results prove successful – and the FDA approves limited sales of the new drug to an extremely small population (those with extremely high triglycerides). To expand the use of the drug to a larger population, however, the FDA gets you to agree to commit to spending hundreds of millions of dollars to conduct long-term tests that will take several years to complete. In exchange, the FDA agrees to allow expanded sales once the tests are well underway.
Then, just as you have spent hundreds of millions of dollars to meet your part of the agreement, the FDA suddenly – and mysteriously - reverses direction and, in an unprecedented action cancels the agreement without just cause or due scientific process. With no recourse, except more appeals to…the FDA.
Again, this is an unprecedented action by the FDA, and was never communicated beforehand to your company.
Moreover, information regarding various FDA personnel involved in this unexpected maneuver indicates major conflicts of interest with big pharma rivals working on similar therapies - and a large hedge fund.
Going forward, the FDA continues to stall decisions, appeals, and even lawsuits to keep from having to allow your small company from being cleared to sell its drug to a larger population. Your stock price drops from $17 a share to under $1 a share within months. While still committed to spending hundreds of millions more to keep this drug alive, your company is suddenly on the ropes and fighting for survival.
A Senate Committee has recently asked the FDA about its behavior about the cancellation of this agreement (called an “SPA”), but due to the endless bureaucracy, it’s highly likely the FDA will get away with their actions and the real truths will never come to light.
That is, unless a news program like “60 Minutes” steps in to bring these matters to a larger audience.
If this can happen to small pharma companies – including those working on important new drugs to combat cardiovascular and infectious diseases – is the FDA really acting in our best interests? Or are they acting on behalf of big pharma, and Wall Street?
Is “60 Minutes” interested in this kind of story, then please contact me. I am a physician from ___________, and can point your editorial staff to several important website and other sources of information to help you make a decision about whether or not this is a newsworthy topic.
My number is _____________. I hope to hear from you soon!
Back to the science for a second. Please excuse my naivete, but is it possible that it's the anti-inflammatory properties of EPA molecule that presents the best argument for CVD reduction, or is it the triglyceride lowering function? OR, is it perhaps EPA's anti-inflammatory properties that perhaps do double duty in reducing CVD and lowering triglyceride levels (regardless of their culpability in CVD)?
What prompted my question is my reading on how other drugs (birth control pills, diuretics and steroids) elevate triglyceride levels. I was thinking perhaps these kinds of drugs may have disruptive, and perhaps INFLAMMATORY effects on certain systems, with a resultant rise in triglycerides.
JL, others, I would love have your thoughts on this.
Getting "60 Minutes" to do a piece on Amarin/EPA is probably too narrow a focus for them. THAT SAID, they MIGHT be much more interested in doing a piece on the Statin industry and its influence on everyone from practitioners all the way up to the FDA. That's when EPA (and possibly Amarin history) might come in handy for them. Regardless of whether or not Amarin gets mentioned, it might help build positive awareness of EPA alternatives - and possible help boost sales long term. And that might well be worth the effort. There's plenty of disagreement brewing over the role of statins - and it might be a good story for 60 Minutes, esp. due to their viewer demographics.
Nofan: "You can continue to blame the government for every bit of bad news. OR You can start blaming Management."
OR, you can probably do better by assigning blame around where its appropriate. Certainly management has not been perfect, but neither has the FDA. There's a lot of blame to go around.
It's all about where we go from here, and - I agree with you - it's about selling the product.
I don't blame doctors for being reticent to write prescriptions for a new EPA product, even if it's "best in class." This I believe is due to a wide range of issues, including education, uncertainty on behalf of leadership organizations, all sorts of conflicting studies, and a plethora of approaches to cardiovascular health issues. (Just yesterday my cardiologist told me he now believes mere dietary changes - cutting out wheat, rice and such - are going to do the trick for me, in addition to my low dose statin regimen!)
I'm hoping there will continue to be - in addition to ANCHOR study - plenty of new studies about the benefits of trying a purified form of EPA. JL has repeatedly pointed out the inflammation angle on this chemical, and if it holds true, this ultimately will be more about anti-inflammatory properties of Vascepa beyond just the CV market.
Management's most recent communication may indicate they are going to concentrate efforts going forward on increasing sales in order to bridge the current "valley of death" mode currently illustrated by the PPS. I am hoping Management has figured out various plans for long term growth.
I suggest a Time Out for all the Chicken Littles on this board. The most recent wake of "bad news" (such as it is) has almost everyone sniping at each other. "management needs to go", "we need to sue FDA" "delisting is imminent", arrrrgh!
The company has plenty of cash on hand to be operational well into next year and likely well into 2016/17, as well, if scripts continue to increase meaningfully. And with KOWA helping to sell, I expect scripts to increase at a higher clip sometime in the 4th Quarter.
Management obviously has a number of options to consider as to current regulatory processes, as well as patent protection, etc., but my guess is they won't be relying on us to guide them. They are experts, we aren't.
Please, let's get away from anxiety-based assumptions, scenarios, guessing games, etc., and try to post something insightful next time.
If you all can't wait 2-4 weeks to see what steps management takes next, then you obviously don't have the stomachs to be investing in biotech. Take a couple of breaths and lets get back to some sanity here.
Let me add my two cents to your very good post, Birzinho. The issue here may not be a standard "breach of contract" as we know it commercially, but essentially malfeasance. Public officials can be sued for malfeasance.
I think it entirely possible that a judge would likely rule that FDA's determination of "SUBSTANTIAL scientific issue essential to DETERMINING the safety or efficacy of the drug" is not just erroneous but willful. (Especially is improper notification of AMRN is also demonstrated.)
Just recently a judge ruled that FDA's procedures on an ADCOM clearly violated conflict of interest standards...so their administrative track record is not in the greatest shape.
I doubt AMRN would take such a drastic path as a breach/malfeasance complaint. However in order to keep that possibility alive, their leadership may be required to give FDA every opportunity to correct their mistakes. I would not be surprised at all if they went through the entire appeals process, regardless of FDA's record of denials.
Bottom line, I hope NCE and sNDA decisions make this a moot point! Nobody wants this to go to court, if it can be worked out another way.
JL, I say let 60 Minutes make the call as to whether this matter is newsworthy enough to pursue. They don't always need a smoking gun to be interested in a story, although I think several conflict of interest issues (not limited to AMRN's story) are substantial enough for them to want to look into it further.
This is another example of of government agencies ignoring their mission, as set forth in congress...it could easily fit into a larger story that 60 Minutes may already be considering. The oversight agency for car safety is currently getting slammed big time, and it's newsworthy. The AMRN story has a parallel fit. They could also interview members of the congressional committee to learn more about recent directives to FDA to clarify their protocols...
Additionally, I don't think ADCOM members would be all that willing to speak to the press about that particular debacle, if they know it's 60 Minutes doing the questioning. Documentaries don't have to adhere strictly to "fair and balanced" at all times, anyway.
So, in summary, let's put the best elements of the story in front of 60 Minutes, and let them make the call. No harm in that, is there?
After hours trade blocks of 923k and 461k. 8 and 10 minutes after closing, respectively.
1) First clue comes quickly, in today's statement: Specifically 8-k language: "However, FDA concluded that in its view the totality of scientific data and information, including its reevaluation and improved understanding of the relevant scientific knowledge since the ANCHOR trial began, does not support use of decreases in triglycerides as a validated surrogate for cardiovascular risk reduction in the proposed patient population." Particularly the "including" part of the statement, which - although it appears to be simply a summary of the FDA's decision - points strongly in the direction of the company feeling it can make a strong case against the FDA's reasoning. Notice also, the inclusion of calling out the nature of the failed drugs as fenofibrates and nicotinic acid. Sounds like someone is getting their ducks in a row to me - either for further appeals/discussions with FDA relative to sNDA, or for 1st Amendment purposes.
2) Your very artfully veiled aspersion that I may have engaged in the folly of past advocacy efforts on behalf of AMRN, via letters, emails, etc. is completely wrong - I have engaged in none of those efforts. (Although I do very much applaud other investors who have taken time to shake as many governmental/regulatory/media trees as they can.)
3) Also, cut it with the claims that I have very little knowledge about the "plumbing of WS." My original comments had nothing to do with WS activities. Plumbing is for toilets.
You are reaching in all the wrong directions. So please also cut the "with all due respect," too. Pretty much everyone sees through that stuff.
LAD, in light of the July 2014 vote for Board of Directors
(Mr. John F. Thero 44,996,686 FOR and 2,708,976 AGAINST, Dr. Lars G. Ekman 43,184,072 FOR and 4,517,832 AGAINST, Dr. James I. Healy 44,752,294 FOR and 2,954,648 AGAINST) I sincerely doubt a "grassroots" campaign by common shareholders has any chance of toppling management. (Has it ever happened, I wonder?)
It seems much more likely to me that Management, with the Board's guidance and blessing, is quietly working on various plans and contingencies for improving the long term success of this venture.
Regardless of the daunting combo of current regulatory/competitive/fiscal/legal challenges, I believe current management has a much, much higher chance of succeeding (xx%?) than your "off with their heads" campaign (0%).
Call, email and mail letters to every BOD member if you like, but this tactic will serve only as a mindless nuisance to the people actually fielding your complaints - their support staff.
Today's News on Alzheimers and Cholesterol - Relevant?
Not sure what this may portend for a compound like Vascepa, but the NY Times Science section today has an interesting article about apolipoprotein E as it relates to dementia/Alzheimer's. I leave this to the experts on this board, and if this is irrelevant, then I apologize in advance.
The article is entitled: "Tactic in Alzheimer’s Fight May Be Safe, Study Finds"
What is FDA Thinking? Nice post - esp. the missing link idea. What we may be missing is an accurate idea of how the FDA is working these days. I don't think any large agency like FDA is in complete lock-step about anything. So the "FDA" probably isn't thinking anything.
What may be the problem - and perhaps cause for some significant delays - is that currently the FDA is undergoing political turbulence about the agency's mission and procedures. There's got to be a lot of political machinations in an agency that large.
Just a theory, but wouldn't this explain quite a few of the difficulties Amarin has experienced? The blind-siding of the ADCOM? Delays, delays, delays? And perhaps even the heightened scrutiny from the Senate?
It might also portend greater chance of reversals at the higher level of appeals for Vascepa. Certainly there is good evidence that Dr. Jenkins has had to over-rule some of these shenanigans at the lower level.
Yes, I am loyal, suffering long.
Joe Z's current Executive Profile on Bloomberg shows that as of July 24, 2014 (!) he is one of the Directors of Gliacure. This is a privately held company in Boston. They are focused on the development of novel therapies for neurological and neuropsychiatric disorders based on glia targets.
Also, his Executive Profile shows a Bachelor's Degree in Chemical Engineering and an MS degree in Biochemical Engineering, both from Drexel. He followed up with an MBA in Finance from Indiana University. All good credentials.
I bring this up because I want to make a point of identifying where Joe's strengths as a leader may (or may not) be. I think for the bulk of his career he has been chosen to lead companies based on his experience and ability in bringing new drugs/therapies to fruition. He may or may not be all that interested in taking companies past that point.
I don't believe it was a mistake to have him lead Amarin during the time period in which the company was trying to get final approvals for expanded populations. He is very confident about Vascepa, as a chemical and as a great development in CV therapies. And he touts the patents as the lynchpin of success for this chemical.
As for financing, as soon as it became apparent that the FDA wasn't managing the process in the way Joe and others expected...then additional financing options became an urgent necessity. We simply have to get through a much longer period of time than originally anticipated.
What Joe probably isn't interested in, as a CEO, is leading a sales effort, and all the operational details involved in that effort (including to some degree, financing). Based on this, my assumption is that his retirement as CEO was a mutual decision, and his retention on the BOD is related to ongoing research/study efforts. He also has a huge financial interest in the success of the company. His new position at Gliacure supports the idea that his heart is in Development and not in Operations.
Simply put, I believe Joe was the right guy at the right time, and as soon as the scenario changed, he did the right thing by bowing out and letting someone else take the reins. He wasn't "canned" and he hasn't been a failure.
I also feel all the concerns about the financing issues will be resolved, once sales reach a certain level. When your company starts becoming successful, financing terms get a lot easier.
The tobacco decision was Lorillard (and RJ Reynolds) vs FDA. You can read the ruling somewhere, if you search. I read it, and it pales when compared to conflicts of interest related to the Amarin ADCOM. So I agree, you should include a reference to that in your letter.
Best post of the day! I'd hate to be an FDA attorney / FDA manager after that decision. This clearly puts more pressure on FDA to consider reversing direction set by ADCOM, SPA decision, etc...I am getting more hopeful every day. Thanks, BB.
ladavis, I really don't care to speculate what happens if NCE complaint is dismissed by judge, because, again...that was not my point. My point was only to the necessity of filing the complaint as part of the fiduciary responsibility of AMRN management. If judge rules against AMRN it may or may not have a on SPA problems - depending on the judge's comments in the ruling. If judge rules for AMRN, it may or may not have a bearing on SPA problems, depending on the judge's comments in the ruling. Regardless, I was responding to the idea that the NCE complaint is a complete waste of time and money. Perhaps it is, but if they don't pursue the complaint, then what? Shareholders sue for not defending their interests? Hmmm. Like we need another shareholder lawsuit right now.
JL, much respect here, too. I look forward to all of your posts. However, my first point was about fiduciary responsibility to uphold shareholder value (and there may be meaningful value there - not much but something), and my second point about impact of a pro-Amarin NCE decision on FDA's approach to handling the SPA controversy. For instance, NCE proceedings may shine additional light on FDA's procedural flaws related to Vascepa. I agree - NCE is minor and not intrinsically tied to SPA, but there may still be management issues at stake for both AMRN and FDA here that compel the NCE suit.
NCE suit has become a necessary action, I believe, because NCE has some meaningful impact on the value of the company. If so, the directors may have a fiduciary obligation to sue to achieve that inherent value.
Regardless of past management statements that downplayed the factor of NCE relative to SPA, they still have to recognize its importance to the overall success of the company.
Another reason to believe the NCE suit may be important is the potential impact it may have on the SPA appeal, should the judge rule in favor of Amarin's NCE complaint. If this happens, I believe the FDA will be even more motivated to re-evaluate their decision on the SPA.
So Amarin may well have a number of good reasons to spend money on the NCE suit.
Is there any chance some of the additional expenses of financing arrangements may be recoverable via legal actions, appeals, etc.? Or is that a hopeless cause?