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rafunrafun,
"I was just following orders" seems to be the line of the folks who've made the worst acts recoded possible.
I used to think like you but I no longer have symphony for the minions. Theses are supposed to be professionals in their field (some just masquerading). Shame on them if they choose to be part of corruption.
Whether it's someone selling bogus investments or govt agents suppressing/ignoring information to maintain a lie, everyone has a choice.
Hey ZiP, "FDA is neither stupid or overtly corrupt"
I'll say this much. I dealt with a gov't agency for an extended period of time awhile back and their willingness to believe their own bull shite was stunning. Actually, it was scary, given their ability to drastically affect (for the worse) the lives of citizens.
I'm not joking, man. That experience was an epiphany; I finally understood this incredible fear some people have of big govt.
Are the employees stupid? Individually, probably 50/50. But they're like a cult. Once the smart 50% join the club, they're indoctrinated into stupidity.
Corruption is just a natural side effect of their sickness. It's unavoidable. It's what follows when you convince yourself you're right and refuse to be moved no matter the damage caused.
Stupid and corrupt? I'd say that's a nice way to put it. They're much worse than that, though.
HD, I'm normally with you bro but I'm going to have to disagree with you on Kowa. I know you're working with the info you were given but that "5-call" crap is complete horse shite.
To be frank, that data point could have come from some 2-bit marketing research firm in butt-fudge Idaho. Who knows. But because JT regurgitates it on a c.c., it's supposed to be written in stone? Please...
Kowa stinking the joint up isn't because they have yet to make 5 phone calls; they stink because of other reasons (no insurance, could care less, fantasy football). Who knows. But one thing I do know is it's not because of some 5-call minimum.
I'd be ecstatic if sales pick up quickly and significantly. But if that's going to happen, it's going to be because of skilled salespeople. I've dated a couple of lovely pharma reps in my time (patting myself on the back) and have also done some phone work as well.
Dialing is a numbers game in the sense that the more folks you call, the more likely you are to speak to someone. But when you do, you need to sell that person.
To think you get brownie points just for dialing / visiting the same doctor 5 times is asinine. Jesus, what's going on in JT's head? Man, he's just lost sometimes.
ps. the derogatory comments were entirely directed toward JT
Alternatepatel, ahhh, the old days. I was having dinner with friends in Paris the night amrn received Marine approval. A buddy texted me with the fda's decision. The food, the wine, the news; it was a perfect night. I was riding a sizable option position from $9 to $15 and thought it was just the beginning of what would be an incredible run. Now I'm looking for work as a dog walker in NYC (exaggeration for effect).
How I yearn for those old days...
Re: Pharmakon, interesting convo in comments section of seeking alpha b/t David Hughes, author and STS66 concerning its interest in AMRN. Seems they are turn key -- co. fails terms of agreement and the intellectual property is handed right over to Pablo Lagorreta.
Pablo Legorreta -- co-founder and Managing Member of Pharmakon, is also the founder and CEO of Royalty Pharma. Royalty Pharma is the industry leader in acquiring revenue-producing intellectual property, principally royalty interests in marketed and late stage biopharmaceutical products, with assets of over $7 billion.
http://bit.ly/1tbaOJK
http://seekingalpha.com/article/2586135-amarins-value-with-or-without-reduce-it-and-a-final-word-on-management
Point being, I think we (or just me) "assume" Pharmakon has Amrn's best interests at heart. However, they do stand to make more inheriting the IP (if patents hold) and sending directly to Royalty Pharma than giving us a helping hand.
Now, that's pure conjecture and I certainly don't want to think it prefers default to payment. Just saying, it may not be so eager to help.
But your point (which is most important) remains true; plenty of options outside of dilution.
Lead times involved --
I don't have a degree from MIT but let's see how I do.
OCT 28th 2014 minus the July 26th 2012 approval date...carry the 1... add 2...divide by 3...
Ehh, that's roughly 27 months, or 2.25 years. Those communist lines over in Soviet Europe must be much longer than I thought! (tongue in cheek, I love my european bros and sis')
Yeah, IR's answer is pretty disingenuous. Safe to say, it clearly wasn't an option the company considered or pursued when it should have been doing so.
Once again, I have to ask, "why are they getting paid?" That is to say, are they taking lemons and making lemonade? If not, what is it that they're doing with the lemons to add value that exceeds their paychecks?
I have (a little) faith in JT. Maybe, just maybe, he'll shed some light on the CC.
HD, Thanks. Just checking. I was looking at (21M) in op. income myself.
I agree with you 100% that amrn does not need to be cf positive to reach interim. My thought is, can amrn risk going into the interim analysis with just one or two quarter's worth of cash?
If the data is incredibly good, the world is amrn's oyster.
But let's say the data is positive but not blowout quality. It would be tough to raise $ under this set of circumstances.
I think they really do need to align themselves with someone to avoid this scenario.
HD, KIwi, anyone else have any thoughts on these numbers?
HD, I know you posted your own set of numbers previously. Just wondering how they look to you.
http://seekingalpha.com/article/2586135-amarins-value-with-or-without-reduce-it-and-a-final-word-on-management
Raf (and all), read this:
http://seekingalpha.com/article/2586135-amarins-value-with-or-without-reduce-it-and-a-final-word-on-management
I think it paints a fair picture.
Kiwi,
Thanks! If you can't have a little fun on a board moderated by folks with names such as Investorfreak69, where can you?
:)
HD
I apologize; my words were confusing. I was referring to the BioPharma deal and quarterly cap.
In terms of the overall quality of the deal and its benefit to shareholders, this option stands out.
I hear you on not knowing the %. We can make some assumptions but, to your point, not knowing the cash flows makes that a crap shoot.
Hi 1bill, Sir,
A bit of light-hearted humor never hurt anyone. You do realize (as I do) that my comment will have zero impact on anyone's right to life, liberty and the pursuit of happiness. Just like your saying my post "sucks" will not affect my evening (although it did make me laugh).
Read my posts (if you're bored) and you'll realize that, I too, have provided this board with "much needed legitimated truth", though not nearly as often as other regular posters.
My comment was merely to make note of how some folks go after anyone who presents an opinion that isn't "rosey", so to speak. But do know, Sir, that I am a owner of amrn and have the same hopes and aspirations for the company as you.
HD and Kiwi
Kiwi -- My comment on Jessie was tongue-in-cheek. A bit of low-brow humor, definitely (but I did chuckle at the thought). I do agree with you that the odds are in our favor. It's been a long time coming.
HD -- Bingo. Yes, the loan AND some dilution and no complaints from me. The subsequent dilution really set me off. The value of this loan, I believe, was in its structure and the provisions it provided SHOULD a buyout have occurred before the end of 2013. It was an effective bridge to get to anchor and BO. The modified interest payments are a very nice feature (life saving) but believe the company overplayed its hand. The misstep for me was not planning for a double whammy -- no Anchor, no buyout. A proper probability tree would've shown this outcome having some chance of occurring.
I'm excited about the chances of an expanded label. With it, I believe Kowa will take over the sales operation (expanding sales force and the like) and believe the stock will see double digits within 6-12 months. I was actually quite shocked they pulled off what I thought was an excellent partnership and can see a lot of synergies between the two companies (even if it came a bit late). I bought more shares after the announcement of the deal. Hopefully I don't get buried for a 2nd time!
HD, Bravo! Unfortunately, I do have to ask -- why would you post factual information that paints such a gloomy situation for our beloved amrn for this lot? I mean, you're driving guys like Jessie crazy! He's probably been stewing all day, sitting in front of his computer for hours trying to think up a way to expose these numbers as incorrect. (I'm just having a laugh) But they're not. 40k, more or less, is the number.
A small contingent of folks here refuse to accept what is, in my very humble opinion, a truth; amrn crack mgmt's decision to take on the pawn shop pharmakon loan vs diluting in the 10's set off a chain of events that have ultimately turned this company into a binary bet. Because of this single decision, every FDA action against us (as unjust as they may be) has been magnified and forced us deeper into a hole. So deep that the company is now nothing more than a bet; an option contract on the direction the FDA will move in September. Good news and we move up significantly. Bad news and we drop below the 52-week low based on the very high probability the company will dilute.
Dilution at these levels means everyone's ownership will be cut in half. Won't be the end game but the company is not viable on marine sales alone due to it's current expenses.
Your question on rx renewals is poignant. The fact that the best in-class drug has yet to hit an inflection point is glaring, at least, to me. Something is amiss. Rx's are not accelerating at a pace the math would suggest.
Amrn's rebate costs as a percentage of revenue are flat to increasing, suggesting the company has to continue supporting sales vs the insurers. I'd guess, whatever the reason, it may be exacerbated by a negative decision, putting a drag on future rx growth. The company cannot fund itself into the future on 10-12k/week rx's. Or, I should say, suppliers of capital hoping to get paid won't let them continue to operate without increasing capital.
Anyway, whether you agree with my sentiment or not, keep up the good work.
HDGabor,
In my humble opinion, I have a hunch this is a result of the pharmakon loan. I had forgotten how aggressive the pay-back schedule became over time.
The fact is, even if we double our rx's, it appears we won't hit the $80M burn rate due to what will be rising interest expenses -- to the tune of close to $30M this year alone.
This means rx's need to go from 7k to (fill in the blank). I'd say 20k. Can we do it?
Now, the caveat is we have a "quarterly cap" option and can pay a percentage of revenue instead of the $8M/Q scheduled and push the remainder in the future (paying interest on interest). What's the % we pay? It's listed as *** on the 8-K.
*** is defined as:
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934
Might anyone else know this number or is it a well-kept secret?
So why didn't they wait for Kowa? It appears amrn has accepted the fact it will pay the portion of revenue vs scheduled payment. It's possible Pharmakon forced the issue, recognizing amrn may not have the $ to pay them when the big pmts start kicking in based on the fact that large pmts to both them and the convertible guys would coincide.
Think about it.
You're logic is correct. It's hard for people to understand the cost because the raw number isn't staring them in the face. It's like an internal fee that looks puny on the surface but shocks you when broken out and valued over time.
In terms of communication, it could be two-fold.
1) They really are playing this by ear and hoping sales save the day before they have to make another big decision.
2) They are attempting to overcompensate for a previously boisterous guy (JZ) who certainly irked the legal dept and put the co. in harms way.
Hey JL, is it an art or a science?
Thanks for the reply. I appreciate your candor and efforts in providing info. Like others have said, I do enjoy reading your posts.
What I'm looking for (and I think others) is a sign that mgmt is fighting/scratching/clawing for every penny in every deal it does. And, for whatever reason, it always seems the co. leaves a bit to be desired.
Some of that is the stench JZ left. On one hand, he was comfortable enough to say, "not a penny under $30". On the other, he left investors and analysts clueless as to what was happening. This is not conjecture; he made that bed.
Having structured deals in the "real world", I'm aware of the intricacies involved. In terms of this deal, the values can fluctuate wildly due to the subjective nature of the inputs. The question is, is it art or science?
For example, it wouldn't be shocking if a banking institution viewed amrn as a "not going concern" three years from today. Solely based on balance sheet/cash flows and sales trajectory, it's a valid argument and would make a loan very expensive. But an institution valuing the future of this drug and its marketplace would see it in a much different light.
So, the value the 2-yr option amrn purchased really would be in the eye of the beholder.
Folks can look at the Mona Lisa and, while appreciating the work, value different attributes. We can all agree that delaying this event by two years is a good thing. However, I fall into the camp of Kiwi and HD Gabor in asking several questions:
1 - Was this needed at this very moment in time? (Kowa rx growth = stronger financial position / less expensive options)
2- Does this actually get us any closer to 2017? ($0 cash inflow = possible future dilution or BK)
3 - Did we pay too much? (with this and the previous deal, $10 is the new $20)
The future will answer these questions. To sell or not to sell? I'm already numb to the price (since 2012) and will hold what I have left until R-It.
What's done is done. However, we shouldn't stop scrutinizing every deal. The manifestation of an efficient market is price discovery. If we, as capital providers, don't seek this, we lose the right to call ourselves investors.
JL, my bad. Amrn's option to make good utilizing cash or shares was applicable only to the bond holders seeking to convert at the exchange rate (which they would only do if in the money)
You're right in that the holders could put the bond to amrn at par on the specified dates.
I definitely put the cart before the horse on that one. I'm still working on the cost portion, though. The cost will ultimately determine if the deal was fair to both parties
Whalatane, debt schedule is as follows:
3.50% on $150M = $5.25M/ Yr or $2.625M every January and July
The Pharmakon schedule, pulled from amrn's 8k on 28 Feb 2013 (and yes, those are quarterly pmts) http://files.shareholder.com/downloads/AMRN/3102499193x0xS1193125-13-84191/897448/filing.pdf
2.1 PAYMENTS DUE TO PURCHASER .
(a) (i) Until such time as Seller or its Affiliates have paid the Threshold Amount or otherwise met the requirements of Section 2.1(e)
or Section 2.1(h) , then subject to the Quarterly Cap in Section 2.1(b) , Seller will, or will cause its Affiliates to, during the Payment Period, as
applicable, pay Purchaser the scheduled quarterly amount set forth in the corresponding table below (each, a “Scheduled Quarterly Amount” ):
(1) each Calendar Quarter occurring
Scheduled Quarterly Amount (in the event it is not a Quarterly Cap Event Quarter)
in the last two Calendar Quarters of 2013 $2,500,000
in 2014 $8,000,000
in 2015 $10,000,000
in 2016 $15,000,000
in the first Calendar Quarter of 2017 (in the event no prior Quarterly Cap
Event Quarter) $13,000,000
(2) each Calendar Quarter occurring
Scheduled Quarterly Amount (in the
event there is or has been a Quarterly Cap Event Quarter)
in the first Calendar Quarter of 2017 (in the event of a prior or current
Quarterly Cap Event Quarter) The lesser of (1) the Outstanding Threshold Amount and (2) [***]
in the second Calendar Quarter of 2017 and thereafter (only in the event
of a prior Quarterly Cap Event Quarter) The lesser of (1) the Outstanding Threshold Amount and (2) [***]
JL, please take a look at the following statement:
In addition, on January 9, 2012, we issued $150 million in aggregate principal amount of 3.50% exchangeable senior notes due 2032, or the notes. The notes are exchangeable under certain circumstances into cash, our ADS, or a combination of cash and ADS, at our election, with a current exchange rate of 113.4752 ADS per $1,000 principal amount of notes. Although we intend to settle these notes in cash, if we elected physical settlement, the notes would initially be exchangeable into 17,021,280 ADS.
http://files.shareholder.com/downloads/AMRN/3102499193x0xS1193125-13-84191/897448/filing.pdf
This is amrn's 8k released on 28 Feb 2013. Page 40 of the document, 2nd to last paragraph. I don't want to jump to conclusions just yet as I haven't had an opportunity to completely review the document. But if it truly was amrn's discretion to settle the bonds in adr's vs cash, this restructuring was a complete theft of shareholder value.
Once again, I need to take a closer look. I could be wrong. I'm currently searching to see if I can find all the details of this initial offering.
But I think we need to parse the original deal and the cost of this current deal a bit further.
Whalatane, No, it does not. Tic Toc
The New Notes will bear interest at a rate of 3.50% per annum from, and including, January 15, 2014, payable semi-annually in arrears on January 15 and July 15 of each year, beginning on July 15, 2014.
https://www.sec.gov/Archives/edgar/data/897448/000119312514199919/d728525d8k.htm
BioB,
You know as well as anyone there were missteps on mgmt's part throughout this process. To say you can't be upset with them is a bit of a stretch, to say the least.
Plus, if they start feeling a bit blue, they can always create a new bonus plan for doing the impossible. Something like perfect attendance at work.
HDGabor, someone on this board said you were a smart fellow and I concur. You seem to be genuine in your questions and responses. So I apologize for insulting you previously. Plus, I was a bit tipsy at the time and my gf was irritating me.
You're asking all of the right questions. The problem is, you're not going to like the answers you seek. I haven't broken down the numbers yet (because I'm drinking again) but, on the surface, this deal seems very expensive -- especially, as you correctly stated, it does not add a single $1 to the balance sheet.
I think this latest act by mgmt explains my recent post.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=101929405
This board is full of very intelligent individuals but, to my dismay, many wish to ignore the value mgmt is constantly destroying to focus their attention on the fda and other matters. But, in my opinion, the decisions mgmt makes over the next few months will be critical to salvaging the share price for investors today.
However, right in front of our eyes, at a moment where every decision is vital and demands the utmost scrutiny, they give Corscicanto a sweetheart deal -- the same people I mentioned as "annihilated" in my last post. Yeah, they're having the last laugh.
And in response, only a few folks are scratching their heads. To the contrary, more are applauding the deal. At minimum, even if we all agree amrn needs the extra two years, I think closer scrutiny will show this was a very expensive price to pay. I mean, would you want someone using your checking account to constantly overpay for groceries? If not, then it is a problem.
The decisions mgmt makes over the next few months will be critical to salvaging the share price for investors today (and by that, I mean panicking and diluting out of fear the share price will continue to fall). We can't keep giving them a pass and blaming the fda. There are variables this company can control. We need to hold them accountable.
I mean, for pete's sake, this has to be the only company on the face of the earth that, facing a cash crunch, can dilute and not raise a nickel!
Page 21 - Royalty and Milestone Obligations
http://files.shareholder.com/downloads/AMRN/3102499193x0xS1193125-14-191000/897448/filing.pdf
On December 30, 2013, the Company issued a notice of termination of its API agreement to BASF as
a result of BASF’s non-compliance with the terms of such agreement. BASF did not remedy within a contractual 60-day cure period
and as a result, this agreement terminated on February 28, 2014, though the Company may enter into a new development and supply
agreement with BASF and may purchase supply from BASF
Bidmark,
You missed one of the points I made. I apologize if you were insulted; I was getting a bit irritated at insults directed toward ajax because he wouldn't satisfy everyone's curiosity.
In terms of the CFO, yes, amrn has one listed by title. What I opined is, if you read the terms of the pharmakon deal, this co. has the power to determine how we raise additional funding.
Period. Of that, there is no question.
So, while the CFO has the right to do his or her job, it is Pharakon that makes the final decision. It's all there in black and white.
In terms of you suggesting I wasn't posing fair questions, of that we will have to agree to disagree.
It is not asinine or unreasonable to expect a company to provide ranges in terms or expenses, revenue, etc. Without them, we are left to do exactly what we are doing with ajax's statement -- decide for ourselves.
A portion of the debt is convertible into stock (you think you got killed; those folks may get annihilated).
When amrn accepted the pharmakon loan instead of diluting in the teens, I (and a few colleagues) reviewed the terms and came away thinking two things:
1) the rate was higher than comparable co.'s were receiving, akin to what one might receive at a pawn shop (and, indeed, IP was used as collateral) and resembled a steaming pile of shite
UNLESS
2) it is only being used as a bridge to get to the sale of the company.
Ding ding! This is why I stayed in the stock. The terms included a discounted payback amount should the company be sold by the end of 2013. This was favorable to amrn/us if a deal was done
Now remember, the stock was north of $10 when the pharmakon deal was announced. Pawnshop JoeZ was still playing his ingenious "3 paths" card before taking this deal and the company was absolutely in no position to attempt to go at this for the long haul.
All of the facts above scream the most reasonable assumption to make at this point is that P-shop Joe had an agreement in hand and the final amount was to be determined on decisions to come (nce, pdufa, etc).
What we now know is that he was just bluffing and the loan has become an albatross.
So, let me repeat my first question: were you born or hatched?
Proof..link...link...proof. We want it, we need it!
Are you people mutants? Were you born or hatched? I'm embarrassed to be included in this group of tin foil hat wearing amrn investors.
What makes your demands so incredulous is the fact that you (excuse my caps) OWN THE LEAST FORTHCOMING COMPANY I'VE EVER COME ACROSS!
What kills me is, outside of the folks like ajax and those who've come to his defense (whether they agreed or not), it's clear that most of you actually don't understand what you own. And by that I mean the company, not the drug.
For a group so adamant for proof of anything not bullish on the company, can someone please tell me, in no uncertain terms, exactly how amrn plans to reduce it's cash burn to $80M for 2014?? Link, proof, source?
Because Thero said so? Did you tell you how? How much further can amrn reduce expenses? Anyone? CAN they reduce expenses? Anyone? What is the revenue projection (because they clearly have one based on the "we will be cash flow positive in most scenarios)? Anyone? What is the exact date for Kowa reps to hit the ground? Anyone?
Nope. Basically, amrn does what it's famous for -- making broad statements and allowing you to use your imagination to fill in the blanks. And (excuse my caps) NONE OF YOU BUST THEIR BALLS!
Can any of you say with any certainty whether amrn will wait to year's end before making a decision on dilution? Anyone? Might we all wake up tomorrow morning and get ambushed by a massive dilution?
If I asked the name of amrn's CFO, what would you say? Trick question - it's not a person but an entity. Technically, Pharmakon is the CFO because it has final say on the most important financial decisions regarding amrn. And guess what -- it ONLY cares about getting repaid and not shareholder value (dilution).
Most can not answer even the most basic of questions about this company's finances because you refuse to hold mgmt's feet to the fire, refuse to hold them accountable. While you're attempting to put the FDA out of business, it's amrn that's dying a slow death.
Ask yourself, "why is mgmt always so vague?" Remember the self-imposed quiet period. Haha. What a joke. Well, it's my experience that companies that have absolutely no idea what will happen next tend to be vague because they find themselves "managing" the situation instead of running the company.
You know that feeling you had when taking an exam that you didn't study for? That's the feeling Thero has every morning. And in terms of his $80M number, he doesn't know how amrn will get there either. He's just massaging the numbers in hope that, eventually, sales will save the day.
The scary thing is, mgmt will know before us if sales are picking up fast enough to save their incompetent arses. And, if sales don't, you'll find yourself sitting in front of your computer on a Thursday at 15:59 saying, "hmm, I'm going to give amrn one last week to prove itself; if rx's are poor tomorrow, I'm selling."
And wake up on Friday morning realizing Thero beat you (and me) to the punch and hit the reset button.
Bio, dude, I just clicked on roughly 10 different citizen petitions and CDER showed up every single time when I clicked "view more information". So, I don't know with 100% certainty but I would opine that the cder is not responsible for sponsoring the petition but rather playing some role in processing the comment(s).
BioBill, I am with you 100%. While some may want to attribute investor disdain toward jz to sour grapes or some level of naivety in regard to how the markets work/ bio stocks trade, that simply is a false argument.
jz has made numerous decisions/errors that have backfired and placed this company with "a very special asset" in a very uncompromising position and continues to do so.
i mean, some of the things that he has done are SO DUMB, you are forced to believe we are on the cusp of being bought as they aren't sensible decisions for a company expecting to be a stand-alone, ongoing entity.
You have my support!
Greymatter1, what was the strategy, you ask. Well, there is no strategy! From the "symbolic" buys this week to this rejection, clearly they are just throwing crap against the wall.
"Amarin has not been successful to date in convincing the FDA to accept its appeal for review at a level above the review division within FDA or in convincing the FDA that the appeal of the SPA rescission is a matter sufficiently distinct from the ANCHOR sNDA to warrant separate consideration under the formal FDA appeal process."
It appears (to me) that the appeal was rejected because amrn wished to appeal the rescission of the SPA but the fda has said amrn must first wait for its decision on Anchor because, to them, they are one in the same.
Once again though, for mgmt to be constantly in contact with the fda, you have to wonder what's being discussed in these conversations. Maybe amrn was told beforehand it could request but most likely be denied a hi-level meeting and decided to move foreword anyway. Maybe mgmt is clueless. Who knows.
Coleman's comments are either meant to be a painfully obvious hint as to what is to come for amrn (expansion) or a declaration of war against it and other drugs which follow in its path.
He says the following in the bloomberg article:
The results of a trial with Merck & Co.’s Vytorin, called Improve-It, has the potential to change the equation if the drug’s cholesterol lowering ability fails to translate into longer life and fewer heart attacks, said Colman
“Looking ahead, the results of the ongoing trial Improve-It will provide important insight into the incremental effect on risk for major adverse cardiovascular events of adding a non-statin, LDL-cholesterol lowering drug to subjects receiving background statin therapy,” Colman said.
There are several very distinct parallels between this drug (Vytorin) and Vascepa.
1) Their affect. Accroding to the fda website, Vytorin is "used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol ("bad cholesterol"). Vasecpa does this and more, regardless of how it does it.
2) Amrn is also conducting a trial that "has the potential to change the equation" and "will provide important insight..."
3) This "Improve-It" study is actually mentioned along side Aim and Accord as studies that will "provide important information on the incremental benefit of adding a second lipid-active drug to statin therapy"
4) In regard to the studies, poor results would drastically affect the company as well as the entire space. {This, in my opinion, addresses thoughtful arguments of not granting now to force amrn's hand in seeing R-it to completion. Vytorin is selling but still conducting the trial}
5) Warning on the label -- Maybe a future parallel. Take a look at the bold print under the picture on Vytorin's website:
VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.
So, I say all this because Coleman clearly understands at this point that the fda's decision on amrn will have a dramatic effect as it will set precedent for all other drugs following amrn. With all of the attention on him/fda/this issue, when I hear these comments, my first thought is: why would the fda show flexibility w/Vytorin on its label and allow it to be marketed to the masses with the nasty side-effects it has shown (google simvastatin) while waiting for validation but completely turn down amarin and it's extraordinarily safe profile?
I could be wrong but I'm having a very difficult time understanding the fda's position. It wants the data from both Improve-it and Reduce-it, has shown the flexibility in the past to adjust labels, and is facing a decision that could change the face of innovation for co.'s seeking new cures (for the worse), why would it move in any direction other than working with amrn to get this done?
It's a win-win if it does, a lose-lose if it doesn't. Please tell me if I'm wrong in regard to the science (not an apples/apples comparison) but, on its face, I cannot determine a rational reason for not expanding in terms of the benefit for all parties involved -- patients/fda/amrn vs. the thought process involved in terms of the rationale for allowing vytorin/pcsk9 to market themselves while waiting for trial results.
In regard to the letter, it looks great. The arguments are sound and grounded in facts.
Not that you need my help, but I would suggest shying away from adding anything grounded in nothing more than "suspicion". In my experience, it's the best way to get someone who was taking you seriously to dismiss you as nothing more than a crackpot.
The thing about option trades is those placing them understand they are tracked electronically via algorithms and any aberrations are investigated.
My point is, we have absolutely no idea of the investment thesis for placing this trade; it could be nothing more than a very successful trade.
Incorporating this as an integral part of what we can all agree was an fda process full of wrong-doing may (in my opinion) weaken the argument and cause it to be seen as an attack on everything and anything that seemed to cause/predict amrn's drop.
But, then again, I'm not an expert in this area so take this post for what it's worth.
Labner, sad but I can't blame him. When you invest for yourself, you'll sometimes be willing to ignore issues with mgmt if you believe in the product. But when you are representing (or speaking to) the interests of many others, it's irresponsible to do so.
I know a lot of inst. money that won't touch this with JZ at the helm but would be willing to revisit amrn with a fresh face. The reason is jz has already failed to navigate the fda once; why bet on him to be successful the second time around.
Don't get me wrong -- there will be funds that see value at $1.50. But a lot of that $ will managers rotating out of investments that have done well and doing a bit of bottom feeding. They'll be looking for nothing more than .30-.50 cents, maybe $1, out of amrn (nice return if this is your entry point).
I'm still long and hope amrn (with or without jz) can right the ship but, even if I disagree, can still appreciate the position of guys like Scott.
It's a shame he wouldn't elaborate more on his likes or dislikes; I would like to know his thoughts. I've heard enough from guys like Stephen Rosenman, who couldn't get himself to say a bad thing about jz if his life depended on it and very often (and very irresponsibly) posts headlines such as "nce coming this week", "fda throwing out adcomm", etc. He seems like a nice guy and well-intentioned but is embarrassing in the "accountability" department and never distinguishes in his writing the difference between what he does professionally (consulting) vs. investing.
The value on the investment side in the nearer-term (now - 12 months) most likely will only be realized through label expansion as the limited salesforce will (most likely) not be able to increase revenue at a rate high enough to excite investors on the fence, meaning amrn could be dead money for awhile.
Longer term, I don't need to tell you that (based on today's available medicine), amrn could/would easily be a $20+ stock with successful results from reduce-it. But, even w/successful results, will the face of medicine in this space change during the period of time we are waiting for results?
The good thing is the discussions bt the corrupt/criminal fda and amrn are heating up. We should have answers to our questions sooner than later.
Chas, you're right. While the fda may have infinite resources, the "political capital" of the current admin. is running on fumes.
I mentioned before, there are a lot of very smart people on this site who speak to the science. But I believe it's the economics that are just as important to this story.
At this moment in time, this administration has zero interest in facing a story about corruption in the fda that allows BP's to protect the profits of their less effective drugs due to the stalling of allowing superior drugs to enter the market, which ultimately (over time) leads to higher costs to the masses.
That, in and of itself, would p!ss a lot of people off. Many who are struggling have NO PATIENCE for a story about collusion to keep their prescription costs higher or denying them a better product for the same cost for the sake of multi-billion dollar companies.
As we all know, with twitter/fb/whatever else there is, a movement no longer is 100% dependent on a large news organization to take up its cause.
If it is uncovered that the fda has acted inappropriately, I think an immense (and non-relenting) amount of pressure can change the whole dynamic of this argument. If, in their hearts, decision-makers with the fda are feeling a bit uneasy about this situation, the thunderous foot steps they hear coming may prompt them to walk a more righteous path.
Labner, Haha! I'm glad you like it. I'm close to converting but it's the work of folks like yourself that keep me hanging on.
Dancing, Bingo! The failure to decide on this issue is incredible. Beyond words.
I read something previously about the fda wishing to create more transparency. Well, let's start here. The fda has had the same information on vascepa since it was approved. At this point, there are only two things they can say that make any sense whatsoever:
1) Yes/NO
2) Undecided Based on the following {...}. When we receive the following, we will make our final decision within X amount of days of receipt.
Great! Now I know what you want and approx. when you'll receive it. Now I can make a sound investment decision based on this information.
Not answering nor providing any clarity on what information it is seeking and when it will decide does SIGNIFICANT damage to a company and creates a dead-weight loss in the economy as those providing capital cannot put any degree of certainty around the event.
So, for a country that forces everyone to participate in the equity markets via 401k's/IRA's/pension (forced contributions) etc, it is unacceptable for the fda to feel it has no obligation to anyone to provide clarity.
I watched the ceo/employees of Goldman Sachs sit before congress and answer questions in regard to the information they choose to or not to release to counter-parties. Sh!t, they're trying to put one guy in jail.
Apparently, our gov't thinks (rightfully so) that timely/accurate information is the fabric that holds together the largest, most liquid and most transparent equity markets on the planet.
Yet the fda can withhold what it wants, when it wants, how it wants to the detriment of both investors and (most importantly) patients??
I wonder what percentage of amrn investors have converted to Nihilism? Let me know when the next group meeting is; I'm not far behind you.
Ha. I hear you bro. But it does matter -- in terms of accountability. If the fda has made an error, pressure can (possibly) force them to correct such an error and (hopefully) help us to recoup what we've lost.
Pie in the sky, maybe. But I will say I have never been more wrong (thus far) on an investment in my entire life. And many other very intelligent folks I know are in the same boat. This is a first.
So, if this is a first for us, then maybe the stars are aligned and the fda is about to deal with a few first's of it's own.
Hope (and a little common sense on the part of the fda and mgmt) is all we have left. I'll take it. It beats the alternative.
Interesting thing about the adcom agenda is that the purpose is stated as clear as day:
This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
If this summation is accurate, amrn proposed to do nothing other than reduce the indicators listed above in the stated group. Nothing on the agenda remotely suggests amrn was proposing to reduce cve's (unless I'm missing something).
A lot of facts still unknown -- what did amrn know (if it knew anything more) and when. I'm looking forward to getting a bit more color this evening.
I don't want to put the cart in front of the horse, but if the fda, in no way, shape or form, communicated to amrn at any time that there were concerns about the validity of R-It, there actions are criminal and significantly more egregious than anything Rajaratnam did in terms of destroying wealth or trust in the markets.
We should know shortly. ..
sts66, this is what's listed on the fda's website:
Agenda
The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.