Seeking Alpha

Steve Rosenman's  Instablog

Steve Rosenman
Send Message
Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • Adcom 2-9 Against Label Expansion 59 comments
    Oct 17, 2013 8:23 AM | about stocks: AMRN

    The panel vote seemed like a shock to everyone, although AF had the right and best read on how FDA would treat the situation. I stuck by my thesis, FDA panel did not pan out.

    I believe company needs to step back, partner Marine and drive to successful R-It results - in the absence of another complete shock on Dec. 20th (meaning in the unlikely event FDA ignored the panel as they ignored the SPA, and get approval)

    Sentiment is hold, with trading range-bound until further news develops around forward strategy on both Marine and Anchor, $4-7.

    Stocks: AMRN
Back To Steve Rosenman's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (59)
Track new comments
  • Patrick Harrington
    , contributor
    Comments (26) | Send Message
     
    Keep your head up Steve. There are other opportunities out there
    17 Oct 2013, 08:54 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Steve, I know its a long-shot now, but what are the chances the FDA were to grant approval in December, considering the 9-2 vote against?
    17 Oct 2013, 09:17 AM Reply Like
  • Quoth the Raven
    , contributor
    Comments (2076) | Send Message
     
    $4-$7 price target? Really?
    17 Oct 2013, 09:18 AM Reply Like
  • SA_Member_6137341
    , contributor
    Comments (5) | Send Message
     
    I was too over confident because what I read. Instead I should have gone with my judgment and wouldn't have lost. Hard lesson to learned.
    18 Oct 2013, 03:46 AM Reply Like
  • Attm
    , contributor
    Comments (35) | Send Message
     
    It's FDA who caused the no votes. No hope for the approval for sure.
    17 Oct 2013, 09:20 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    You think the FDA was even going to grant approval when they signed the SPA in the first place, or was it their tricking of Amarin to just get a clinical trial going and wanted to see the results?
    17 Oct 2013, 09:23 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    And what about NCE now? You were so bullish on them getting that. Is that out of the question now too? And does that mean there should be now more delaying of that matter?
    17 Oct 2013, 09:48 AM Reply Like
  • FDA$ucker$
    , contributor
    Comments (2) | Send Message
     
    What's the chance that Amarin will do another NDA for a combo drug Vascepa-Lipitor (or othere statin) using Anchor or other data?
    17 Oct 2013, 09:48 AM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Steve- you need to stop all this SA writing ASAP.

     

    You claim to be some sort of expert in this industry, yet you have not been right on anything. You were just as blindsided as the rest of us.

     

    The issue I have with you is that you never in your articles look at the other side of the coin. You always claim that you have knowledge of positive chatter, but it was all crap.

     

    And really $4-7. Back at it again!
    17 Oct 2013, 10:47 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Yes Steve was wrong but so were all the analysts, institutional investors and retail investors who were bullish on AMRN. Collectively,that represents a whole lot of very educated and smart people.

     

    Piling on now is a classless thing to do. Give it a rest. Nobody who has invested in equities is immune from getting it wrong. The deciding factor in this case was a governmental agency who moved the goal posts, for no viable reason. It appears to me that the fix was in.

     

    Amarin needs to partner. Now.
    17 Oct 2013, 11:07 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    @pirate... you got that right,,, I feel foolish now,, though my feelings have nothing to do with my dd,, in my mind I know I have invested in this product based on the studies iv read,, and especially the market.. and my body feels like it has been violated be a panel that went way off course.. why that is ill never know.. and that's ok.. whats important is that im long in a almost perfect drug.. and speaking bad of others like ring loves to do is part of it.. this isn't the time for rudeness.. people have lost much,, as I have,, and being ignorant at this time is so childish,, good look sr. and all the longs, there is so much more ahead..
    17 Oct 2013, 07:17 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    I agree and I fully take responsibility for my investment decisions.

     

    Guess sometimes its easy to blame someone else.

     

    I'm genuinely sorry Steve for saying what I did- didn't really mean it. What I did mean is that perhaps it would be more useful to examine the bear case along with the bull.

     

    Thanks Pirate for your note- made me rethink
    17 Oct 2013, 11:16 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    I did think it was weird that Hiatt brought up in the last few minutes that it was wrong to sign the SPA and then vote negatively in light of Amarin doing everything on their side of the deal. Tells me FDA screwed them from the beginning by giving them, and us, false hope.
    17 Oct 2013, 11:52 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Sure as hell screwed AMRN! AMRN committed themselves to a very lengthy and expensive outcomes study and took on debt to hold up their end of the bargain. In addition, any and all decisions for commercialization were predicated upon that agreement with the FDA. That is what makes me feel that the FDA is compromised. That knew that changing the playing field would give AMRN one way out.

     

    Unless this is resolved, the FDA has set a precedent that casts a real shadow over the world of biotech. Asking companies to spend millions on Phase 1,2,and 3 trials and then forcing them to complete outcomes studies before having a chance to market their drugs will put a real chilling effect into play. It is counterproductive and untenable for both companies and investors trying to bring new therapies to market. This approach also fails millions of patients that would benefit from these therapies.

     

    If we are to hope for real cures for CVD, this was not the way to do it.
    17 Oct 2013, 12:14 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Ringbellplease - Lots of pain and frustration to go around here. Alot of people got hurt. Some very badly. Myself included. I'll make it as I always do but alot of hopes and dreams evaporated in what appears to me to be a very unfair decision. I have no one to blame but myself.

     

    I believe in the science and that ultimately AMRN will be vindicated. The real question now is how does AMRN get from here to there. I sincerely hope that Steve and others with meaningful input continue to voice their opinions and share their knowledge. Good luck to you.
    17 Oct 2013, 11:56 AM Reply Like
  • Inv Mex
    , contributor
    Comments (13) | Send Message
     
    Pirateescapee - your post above could've been written by me word by word. Good luck to us longs.
    17 Oct 2013, 12:21 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » No issues guys, it's an emotion time given the situation. Only one person I know had the sentiment that actually panned out, and that was AF.

     

    FDA can still accept the indication in December, but it is unlikely.

     

    My original thesis would come back if they live on to fight another day w/ good Reduce-It results.
    17 Oct 2013, 01:01 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Steve - The big question is how do we get there from here? I'm thinking a partnership but I'm not sure whether that ship has sailed or not. Your thoughts?
    17 Oct 2013, 01:06 PM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Pirate dilute to the tune of 125 million shares at 1.8. That gets you through Reduce-It.

     

    Agree with Steve - Outcomes successful - 40 to 60 dollar stock price.
    17 Oct 2013, 01:59 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    mr rosenman,, after losing over 70%, i still believe in the thesis that this novel drug will win out.. my feelings don't outweigh my beliefs, and i know many people are outraged and probably feel quite foolish at this point in time;; so steve why wouldn't amrn cut R-IT and just reapply for just the high trigs for the anchor indication.. i hope i spelled out my question, im a novice trader who made 6 figures in my 1st year,, only to lose it in one day.. but that's my interest. have so enjoyed and benefited from you dd.. please please continue to write.. thanks again
    17 Oct 2013, 08:00 PM Reply Like
  • SJunk
    , contributor
    Comments (17) | Send Message
     
    I totally agree with you steve.
    No one knows for sure about FDA's action on the subject on or before 20 Dec 2013.

     

    GLTA
    18 Oct 2013, 12:28 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » The panel was a circus and the reason AMRN is in this situation is not because the drug failed, but b/c of the FDA.
    17 Oct 2013, 01:04 PM Reply Like
  • aclark819
    , contributor
    Comment (1) | Send Message
     
    AMRN is going to have to back through the FDA regardless of the circus, and whose to say this circus does not occur again? Even if you have faith in AMRN, will they be able to get FDA nod, and will this nod be years from now?
    17 Oct 2013, 09:54 PM Reply Like
  • ozoneranger
    , contributor
    Comments (10) | Send Message
     
    SR,
    Obviously devastating to all us longs. Looking forward, could AMRN change PDUFA request to lower Trigs between 200-500 w/o referring to CV outcomes? While listening to the panel yesterday, it seemed that Dr.Ellen W. Seely was almost suggesting approval if last line was removed(ending at dyslidemea.)."Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?" The panel raised the bar, and still wanted Reduce-it completed, but also seemed to understand a small Pharma wouldn't have the funds to complete w/o expanded indication.
    17 Oct 2013, 01:05 PM Reply Like
  • BillBixby
    , contributor
    Comments (9) | Send Message
     
    ~ "it seemed that Dr.Ellen W. Seely was almost suggesting approval if last line was removed(ending at dyslidemea.)."Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"

     

    Based on this conflicting sentiment of the panelists combined with the ambiguous nature of the voting question and appeared conflation of the ANCHOR and REDUCE-IT studies, I believe there is still a chance (slim though it may be) that the FDA approves Vascepa for the expanded indication with labeling advising that the effects on CVE are not yet determined. The FDA is 10 times more likely to overturn a ruling against approval than for approval.
    17 Oct 2013, 02:41 PM Reply Like
  • Danburydude
    , contributor
    Comments (110) | Send Message
     
    The key word in that question is ' for ' . The question does not read 'grant approval BASED ON co - administration ' .......... The only question this asks is do you think approval of Vascepa and a statin should occur now. That answer was NO .
    That question does not ask if ANCHOR should be approved for an expanded label as a stand alone treatment. I am more firmly in the corner that ANCHOR expansion approval has been decided as per sNDA and this panel was convened to answer the statin combo question. Unless AMRN somehow managed to ask for approval based on statins in February , which is unknown right now, I still feel this was a panel just to answer the combo approval only.
    It would be nice if clarity would come for the investment community. I can tell you who does know the final answer. The same people who in May suddenly knew the ADCOM was all about REDUCE - IT and combo approval. Wouldn't it be nice if they shared this inside information ?
    18 Oct 2013, 04:56 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    Wishful thinking. The stock wouldn't be trading at $2 if that were the case. The tone of the CC says it all. The SPA never guaranteed approval. Just put in place terms for potential approval. FDA changed those terms at some point and we were the last to know.
    20 Oct 2013, 08:21 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » AMRN has a few moves before FDA date coming up in December, legal, regulatory and calling out that idiot FDA reviewer that set up the panel to fail due to confusion and lack of relevant information.
    17 Oct 2013, 02:42 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Good luck with that. The reviewer is but one person within the FDA but it is FDA itself which seems to want keep Amarin out of the mix. Either this is specific to Amarin or the FDA is shifting policy,... period.

     

    If it is the former than we have a real problem with outside influence and a corrupt process. If it is the latter then the FDA is very short sighted and it is possible with enough stink that some sort of compromise can be reached in the interest of drug research and development and plain common sense and fairness.

     

    Regardless, getting into a protracted legal battle or behind the scenes pissing match isn't likely to go in Amarin's favor. Its more of a case of appealing to peoples common sense and decency, highlighting the unintended consequences of the FDA stance etc. You can't do that if you're stepping on toes.

     

    In the meantime, Amarin can't be in a perpetual "quiet period" with its shareholders.
    17 Oct 2013, 03:16 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Yes- the quiet period should end. Enough is enough.
    17 Oct 2013, 03:17 PM Reply Like
  • Patrick Harrington
    , contributor
    Comments (26) | Send Message
     
    I agree the panel was a complete circus show. The fact that the panelists were confused by the question they were voting on was s total debacle.
    17 Oct 2013, 02:59 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Literally 30 seconds before they took the vote, 2 panelists spoke of their concern of the question and what exactly they needed to vote on. Why did they not take more time to discuss what was voted on? They ended the meeting 2 hours early! Unprofessional.
    17 Oct 2013, 03:06 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    I have to believe this is still a $1-2 billion dollar company even with the setback. Would be $500 million sales with BP by 2016. With the potential of Reduce-It wouldn't BP be salivating right now to kick AMRN while they are down and pick up the company on the cheap?
    17 Oct 2013, 03:16 PM Reply Like
  • maillady
    , contributor
    Comments (3) | Send Message
     
    Can you get a support letter written? Look at what the investors are doing in re to Arena. We need someone who can put this picture into words. Im sure public attention would help sway FDA thinking?
    They need to know how ridiculous and corrupt they looked yesterday.
    17 Oct 2013, 05:23 PM Reply Like
  • FDA$ucker$
    , contributor
    Comments (2) | Send Message
     
    Can anybody comment on the whether another sNDA can be submitted either for patients with 400-500 mg/dL of Triglyceride or a combo Vascepa-Lipitor sNDA using the same Anchor trial data? The limited expanded patient population would allow Vascepa to continue to fund Reduce-It and lessen the worry of panel members that too large of a population would be exposed to the drug before Reduce-It outcome data.
    17 Oct 2013, 05:23 PM Reply Like
  • bakemann
    , contributor
    Comments (33) | Send Message
     
    STEVE R.
    thx, for all the articles and DD you have shared with us over the last couple of years. I lost over 30% of my 401k on this and feel your pain. I take full responsibility for my own actions and will recover ! Good luck to you Sir and I hope to read more of your articles soon
    Baker9517
    17 Oct 2013, 05:28 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Steve I know you mean well and you and AF have been going at it but now that he has won so to speak don't start congratulating him.He knows people who know things before you or Amrn longs know it.i Knew when he camein your room here and went head to head he had to know for sure he knew the outcome,it was to much of a risk for his Reputation if he got it wrong.HE KNEW.
    Now as someone above said you have to get real here and know this stock is not at 4 or 7 and wont be for a long time,its under 2 now it was over 7 last Friday for a few seconds.I have been following you and you are part of the reason I lost 20k shares I bought at 14 /11/7/6/5/ but its not your fault,i sold because of greed and people sold today because of fear.Now its time we all get real .905 chance FDA is gonna say no so why even talk about it at those odds.A lot of men cired today and a lot of wifes think a lot less of the person they married and trusted.I didn't tell my wife I sold all my Elan shares at 13 and bought this.
    Anyway we live to fight another day but little cash left, but as I said to my broker last week ,so we have a drug that's safe but not much efficacy [panel think] so its like someone saying you can cross the road there are ot cars on this road ITS SAFE but what if there is nothing on the other side of the road so no need to cross lol.Best of luck everyone im Irish Ive spent the last 2 days in bed looking at the computer because im afraid to put my clothes on and go to the bar [Now That's Dangerous].
    17 Oct 2013, 05:43 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Sorry I said in my last comment I sold my shares because of greed but I meant to say,I didn't sell my shares because of greed and the people sold today at less than $2 because of fear,I don't want anyone thinking I was smart enough to sell my shares at a high price of $ 5 on Tuesday.I may need religion to get me through my time ahead in this stock.Good luck everybody and I have and will always hate AF and the pleasure he gets from people suffering and his followers thinking he is God because he got the answer early.
    17 Oct 2013, 09:45 PM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    You have nothing to be ashamed of dude. You can still look yourself in the mirror and sleep with a clear conscience. You sound like someone who has personal integrity and a code of ethics. Guys like AF and those in the FDA, i wonder. How we live in this life determines where we end up in the next. We all get our comuppance in the end one way or t'other.Those of a materialistic/atheist/... persuasion whose interests are primarily self serving may disagree and good luck to them.

     

    If AF made the case about why the FDA would decline ANCHOR based on the information i have outlined below I would have been all ears. The problem is that if AF did that he would be out of a well paid job. And thats the root of the problem. Were all on our own little journeys and some prefer to take the more scenic dark path route back to the creator. But thats cool, we all have free will. Go out tonight and have yourself a few Guinness, hold your head high and laugh it off as the joke it is.
    18 Oct 2013, 03:20 AM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    Personal integrity remains the worlds scarcest commodity. The FDA is an integral part of a well established racket. How the hell can you say to a company they need to have an outcomes study 50% enrolled involving substantial time and cost before they accept the sNDA for a drug with demonstrated efficacy and safety and then turn around and tell them eh, actually, screw you guys and your fish oil, were changing our minds and want 100% enrollment and completion of the outcomes study showing clear CV benefit before we even consider expanding the label. Its a joke.

     

    The problem I see is fish oil itself and has nothing to do with the actual active ingredient EPA. There is a witch hunt against all fish oil and Vascepa has been passed off as just another fish oil. Thats the root of the problem. Are the FDA ever going to make a fish oil a blockbuster drug? What message would that send out? Take more over the counter supplements like fish oil, eat a healthier diet rich in omega 3's and heaven forbid a diet rich in fruit and vegetables? Let food be your medicine and your medicine food? No no no. Pharmaceutical companes and the FDA cant be seen to be encouraging that. Take the following or leave it but ive done my homework.

     

    We have been socially programmed to seek out medical treatments for illness and disease rather than focusing on cause and prevention. The big money is in disease and treatment. According to the World Health Organization, the United States spent more on health care per capita ($8,608), and more on health care as percentage of its GDP (17.9%), than any other nation in 2011. In 2011, global spending on prescription drugs topped $954 billion. According to IMS Health, the global pharmaceutical industry is expected to be worth $1.1 trillion by 2014.
    The FDA, federal government, the pharmaceutical companies who run the clinical trials to prove safety and efficacy, the AMA, NCI, ACS, accredited medical schools, doctors, surgeons etc are all part of the racket which is basically a private club that has established a way of doing business – making money. They decide and implement the rules and regulations of the racket. Anyone with an effective treatment or apparent cure operating outside this well established racket who does not comply with the regulatory process will be prevented from breaking into the club (forcibly where necessary). A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching (which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail) rose over a five-year period to nearly $1.7 billion in 2003. According to Forbes, development costs between $4 billion to $11 billion per drug. These huge costs obviously create a substantial barrier from entry into the racket.

     

    Cancer is big business. According to the American Cancer Society (ACS), over 1.6 million new cancer cases are expected to be diagnosed in 2013. Cancer remains the second most common cause of death in the US, accounting for nearly 1 out of every 4 deaths. Effective alternative cancer treatments based on plant based remedies and other naturopathic medicine are of no interest to pharmaceutical companies. Why would a company and its investors waste time conducting expensive and lengthy clinical trials demonstrating the safety and efficacy of something everyone can grow in their own back gardens and consume for free?

     

    The ACS attacks non-patentable, natural treatments in an effort to protect the interests of pharmaceutical companies. The ACS' controversial "Committee on Unproven Methods of Cancer Management" reviews unorthodox or alternative therapies, putting many of these treatments on the "Unproven Methods" list. Appearing on this list can mean literal ruin to any health practitioner. Any practitioner assigned to this list is automatically considered a dangerous quack. Funding usually vanishes and the treatment fails before it has even undergone rigorous testing. More than 100 promising alternative non-patented and nontoxic therapies have already been identified and discredited by the American Cancer Society in this way. Included among these are Tumor Necrosis Factor (originally called Coleys' Toxin), hydrazine sulfate, laetrile, Gersons therapy and Burzynski's antineoplastons. Practitioners, activists and cancer survivors are likening the "Unproven Methods" tactic to witch hunts that unfairly target natural therapies over approved and expensive toxic chemical therapies.

     

    The food processing, tobacco and chemical companies help to create the patients that generate the money. Agribusiness and food processing companies sponsor nutritional training in American schools and universities. Food processors bankrolled the Harvard Department of Nutrition. The exponential proliferation of chemicals, particularly in the past half of the twentieth century, has subjected the body to a barrage of chemicals never before encountered. The cumulative effect of those chemicals, toxins and nutritionally devoid food in our diet are a major contributing factor to the degenerative diseases we see today.

     

    What the FDA are actually doing and what the public think they are doing is as different as night and day.

     

    Im 99% certain now that even if Amarin complete the REDUCE-IT trial and the data clearly shows CV benefit the FDA will still find a way to rubbish the study. They will find a major flaw somewhere ridiculous like the placebo mineral oil used or some other such nonsence.

     

    I like many other longs was suckered into the belief that the SPA for ANCHOR actually meant something. You live and learn. Quite an expensive lesson this one but an important one. Am I glad I took a chunk off the table when it was up in the $17's. Those days are a long way off if we ever see them again.
    18 Oct 2013, 02:45 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    hey david,, please continue to set the record straight.. your comments are very insightful.. and most of all truthful.. I so agree with your assessment of some of those who write for the street,, so u should start writing articles.. for more exposure to novice investors.. like myself.. anyway.. whats your take of the future of amrn corp. I personally think that great times are in store for longs.. if all falls into place.. thanks again for your excellent comments..
    18 Oct 2013, 06:00 PM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    Cheers - I wrote an article on the truth about fish oil and seeking alpha wouldnt publish it. I then put it up as an Instablog post on here and it has vanished into thin air. Go figure. Someone wants the truth buried. I've been pondering this whole thing all day today and think I have it finally figured out. This is my take.

     

    It's just dawned on me that this is all about "Vascepa + a statin" - that is the drug and it explains why they havent been granted NCE. Vascepa has zero chance of being approved for the ANCHOR indication as a fish oil alone. Why on earth would the FDA approve a drug 10 times the size of the MARINE indication for a company claiming a fish oil has any CV benefits? Forget about it. People would just start taking more fish oil supplements and eating more fish if word got out that fish oil was of any CV benefit. Thats not what the FDA and pharmaceutical industry want.

     

    Vascepa has to be marketed as a combo drug for the ANCHOR indication or not at all. So until the time Amarin are prepared to partner with AZN or Pfizer or any other big pharma with a leading statin and allow them to sell and market the drug as a combo drug they can forget about it. With AZN or Pfizer etc on board this drug is back on track and the ANCHOR PDUFA will mysteriously then be approved in December.

     

    JZ and co have zero chance of going this alone and being successful because they dont have their own statin. They NEED big pharma. Thats why AZN bought Omthera because JZ was naive and greedy and refused to partner up or accept a buyout offer. There is huge potential for Vascepa and big pharma ARE interested in this drug but JZ aint interested in letting them have it. Big mistake. Look at the share price and the ADCOM farce. The FDA and big pharma will collude to prevent Amarin ever going this alone and reaping the drugs blockbuster potential. Even if they did go it alone and REDUCE-IT does show a reduction in serious CVE's, the FDA will still prevent them from expanding the label citing some problem with the mineral oil placebo or some other such crap. They partner up and things start looking rosy again. Big pharma can easily continue the funding of the REDUCE-IT trial. They end up with data anything close to the JELIS data and big pharma have themselves a blockbuster worth >$10 billion a year. they will also have the supply of the API locked up and an extensive portfolio of patents to protect their asset.

     

    So the bottom line is that JZ's greed and naivity about how the medical racket really works has cost Amarin and its shareholders big time.He should have accepted the $20 buyout offer when it was there. They aint gona get anything close to that now. Big pharma will get this drug on the cheap one way or the other. He needs to partner up or sell the company very quickly or Amarin will be dead sooner rather than later. The market manipulators in control of the stocks share price will see to that, dont you worry.
    19 Oct 2013, 08:20 AM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    Goldman Sachs are clearly in on this big time, no surprise there. The other analysts are a joke and have no clue about whats really going on. Goldman came out with a price target of an insanely low $6.80 pre ADCOM which all longs myself included laughed and jeered about. Thats in and around the region Amarin will be bought out for if JZ finally bites the bullet and decides to play ball with the big boys. With the share price now at $2, a buyout around $7 is all of a sudden a very attractive propostion. JZ continues being stubborn and they will send it down to a $ or under.
    19 Oct 2013, 09:10 AM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Im not going to hog the board but its hard to sleep.When elan stock was taken of the market [tysabri] and people died from it.The investors paid for genuine people on tysabri to travel to the panel meeting ,some in wheelchairs ,so before any fda idiot Chairperson or panel Doc said anything, the atmosphere in the room was electric , people crying ,people who travelled from other countries to beg for Tysabri .The whole panel were like mice and they honestly knew what this drug was doing for the patients even though it did kill people.Result 12-0 yes with huge safety issues but V is different.Its gonna be a rough road for V and investors.Best of luck
    18 Oct 2013, 03:13 AM Reply Like
  • Lelepharma
    , contributor
    Comments (18) | Send Message
     
    can i ask u?
    honestly, why did u sell your shares?
    i understand option traders or people on margin, but do u really believe the value of AMRN is less than, lets say, 4 dollars?
    I know anything can happen but to go worse than this they have to go bankrupt..
    do u believe this?
    or do u fear a dilution?
    a dilution would be to maximize sales for the current indication so the price would eventually go up again..
    Isnt 4 way better than 2, even if representing a loss?
    I ask u coz u seem a smart person and for the time being the idea of sellling didnt cross my mind, not even for a second..

     

    PS
    Another category of people that i understand sold are those that just 'played' the event..the adcomm..
    those people sell, regardless

     

    But i guess u are not one of them..
    20 Oct 2013, 04:22 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    You guys are giving Adam F way too much credit. Has anyone ever seen Adam F admit a mistake or admit he was wrong...Look at ARNA or MNKD or the flip flopping on SRPT back and forth. Adam need to put into his place by someone who got wiped out.
    18 Oct 2013, 01:35 PM Reply Like
  • mimosttr
    , contributor
    Comments (5) | Send Message
     
    Steve,
    Did you happen to catch the BIOWORLD article today regarding Vascepa? Good reading. If FDA is demanding an outcome study for AMRN you can take the same reasoning for requiring studies for many secondary endpoints. This would affect current trials for ISIS, AMGEN, ALNYLAM and others. To quote" The pipeline in CV and diabetes indications is filled with drugs whose benefits are similarly based on surrogate endpoints, and the companies sponsoring those products may be on shaky ground if the decision on Vascepa becomes a precedent".
    I would bet the FDA phones are ringing from BP wanting to know whats going on. You have to wonder if this will come into play prior to Dec. PDUFA.
    19 Oct 2013, 09:20 AM Reply Like
  • stocks_investor
    , contributor
    Comment (1) | Send Message
     
    Voting question was wrong. FDA did not want to re-write it during the meeting.

     

    Asking panel to vote on for which there was no data presented to them is unfair to the panel, sponsor and making a joke out of a govt regulatory body. They cannot be that stupid so other explaination is they're corrupt
    Lowering TG would reduce CV risks, huh!
    Before going into the panel, FDA knew study has only started per SPA so sNDA should be focued on saftey and efficacy.
    Evidenttly they went ahead and asked that they should have at least qualified with what is the downside of approving it untl study is complete. More regulatory work for FDA (isnt that what you'r paid for along with other things) however could save millions of dollars in drug costs and if study holds could possibly save few lives too. There was no need for the panel. FDA can still fix it. I doubt they will though
    19 Oct 2013, 09:33 AM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    The voting question was phrased in such a way that Amarin loses. There was no mistake made. This is a drug worth potentially >$10 Billion annually in the hands of big pharma - NOT in Amarins. Look at the evidence and think about it -the joke that was the ADCOM, the witch hunt against fish oil, the manipulation downward of the share price, no NCE etc has made that clear for all to see. Think about that figure for a minute - $10 Billion. Thats big business and Amarin are going to be denied a free pass and run at it. The fix is in. I hope JZ realizes it sooner rather than later.

     

    There's a slim chance of course that im wrong and ANCHOR will still be approved in December but based on all the evidence would you bet on it? You'd be mad to. All Amarin have ever been doing is the big pharmas donkey work. Sell it to them and they potentially turn it into a blockbuster. Go alone and the FDA et al will bury it.
    19 Oct 2013, 10:57 AM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    I expect Pfizer to make one final offer before year end and Amarin would be wise to accept it. AMRN has already named Pfizer's Lipitor as the statin agent to be patented with Vascepa. There are no shortage of links between Pfizer and Amarin. Declan Doogan was the head of R&D at Pfizer before joining Amarin. Pfizer have the statin, Amarin have the triglyceride lowering fish oil. AZN would not have aquired Omthera if prescription grade fish had no potential. Omthera were aquired for $323 million with additional specified milestones worth $120million bringing the total cost of the aquisition to $443 million.

     

    Pascal Soriot, Chief Executive Officer of AstraZeneca said: β€œThe number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”

     

    So at the very least AZN are definitely interested in the space but with the ADCOM strongly suggesting the REDUCE-IT outcomes study needs to be completed before approval of ANCHOR, Vacepa's clear superiority over Epanova (in terms of safety, efficacy, and the fact they havent even started an outcomes study yet) means it is lagging far behind Vascepa. The Lovaza generic ruling pretty much cancels out Omthera completely.Vascepa also has extensive patent protection and Amarin have already locked up supply of the API. So what is Vacsepa currently worth if Epanova was worth $443 million? There is clearly big potential for a statin Vacsepa combo drug but the only way I can see it realizing its potential is with big pharmas help.

     

    A buyout of Amarin was always on the table. With the ANCHOR indication approved it is obviously worth alot more than it is without. With its approval Amarin could continue to go it alone but with the odds of ANCHOR approval in December having dropped dramatically after that ADCOM, the only real course of action now available is to sell the company. Dumb longs to believe the SPA actually meant anything. The fact REDUCE-IT is already 75% enrolled is Amarin's saving grace. That's worth potentially a hell of a lot to big pharma down the line.

     

    Amarin have also shot themselves in the foot with that financing deal to raise $100 million last December. The Company has agreed to repay Biopharma up to $150 million of future revenue and receivables. The first repayment under the agreement is a repayment of $2.5 million of interest due to Biopharma in November 2013, subject to the limitation described below. Additional quarterly repayments are due thereafter in accordance with the following schedule: $2.5 million of interest in the first quarter of 2014; $8.0 million per quarter in each of the next four quarters, $10.0 million per quarter in each of the next four quarters, $15.0 million per quarter in each of the next four quarters and a final payment of $13.0 million due in May 2017. The quarterly repayments through the third quarter of September 2014 represent interest only.

     

    Except upon a change of control in Amarin, the agreement does not expire until $150 million has been repaid. Under the agreement, upon a change of control, we would be required to pay $140 million, less any previously repaid amount, if the change of control occurs on or before December 31, 2013, or required to repay $150 million, less any previously repaid amount, if the change of control event occurs after December 31, 2013. The Company can prepay after October 1, 2013, an amount equal to $150 million less any previously repaid amount.

     

    http://bit.ly/H4wsMq

     

    So what is that telling you? Anyone care to join the dots? The writing is on the wall, the fix is in. This is how big pharma do business. Without ANCHOR approval Amarin are as good as dead. They are going to have a very hard time paying that loan back without ANCHOR revenue. The current share price totally rules out raising cash by dilution as an option.

     

    The deal will be done by year end or by the end of the first quarter of next year and Pfizer will be unmasked as the mastermind behind it all. You dont get to become the biggest pharmaceutical company on the planet by accident.

     

    So what is Amarin actually worth? Somewhere in the region of Goldmans Sachs $6.80 price target id say. $7 a share is alot better than the stock price will be next year if JZ continues harbouring fantasies of going this alone.
    20 Oct 2013, 07:06 AM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Steve you said you spoke few days before ADCOM that you spoke to a Doctor who had been on several Panel meetings and he said it would go through NO PROBLEM.[a walk in the park]
    Great if you could follow up with this guy as to his thoughts on the failed outcome.Did he think it was a Witch Hunt?Does he think the Panel of Docs really think a drug that's safe but no EFFICACY should deserve a 9-2 NO vote.I think now that we are left in limbo and closer to hell than heaven asking these people questions like this will help us.This stock has been telling us since approval at $15 and all directors selling huge shares and from that day and a huge build up of short shares and even short ing at $5,really do we deserve the pain we feel now.Some will survive emotionally but not financially and sadly some peoples will loose family and friends and peace of mind.We need to be careful from here on as to what we are gambling with ,it may be more than money.
    20 Oct 2013, 11:06 AM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    Absolute crock of an ADCOM. Anchor trials were not based on CV events. That should have had no part in the adcom, much less forcing that into the voting question. If that is how it's going to be, that they are going to just make up new criteria, then it should be mandatory that the "official" voting question be made public (or at the very least available to the company up for approval) PRIOR to the adcom so that a company is not blindsided and completely screwed as Amarin was.

     

    The FDA set Amarin up to fail. If this was the way they were going to go about it, then why even accept the sNDA for Anchor in the first place? Why not deny it and tell them that they want to wait until reduce-it results come in? Why string a company along when you know you have ZERO intention of approving it for what they signed on for under a SPA?

     

    Complete screw job by the FDA. They are basically telling every small corporation out there not to bother trying to succeed, because if you have one that has a drug indication with zero safety concerns under a SPA that met and exceeded every endpoint and you refuse to approve THAT, then every other small company has no chance. You kill innovation by decisions as stupid as this was.
    21 Oct 2013, 11:37 PM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    Why accept the sNDA? Hell, why even agree to conduct the Phase 3 trial in the first place?! Would have saved everyone a whole lot of time and money. This is not over yet though. I say that ADCOM was a deliberate attempt to scare Amarin and JZ shitless and disabuse them of any notions they had of trying to go this alone. The drug has huge potential, thats the bottom line. It's not in Pfizers interests to destroy the company but ADCOM made it clear that unless they sell, the FDA and market manipulators will make damn sure they go bankrupt.
    22 Oct 2013, 12:29 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    david on you on ihub or yahoo message board? we all need your insight..please
    2 Nov 2013, 12:06 PM Reply Like
  • david22hughes
    , contributor
    Comments (245) | Send Message
     
    Thanks for the sentiments but truth is im in the same boat here as everyone else and my theories are just theories. I have no great insight into what exactly is going on. Im making it up as I go along based on all the available evidence. Too many lunatics on iHub and yahoo message board. There's a moderator on iHub with the user name 'Rawnoc'. Have a read of that guys posts and you will see what I mean.

     

    My opinion for what its worth is that the best thing Amarin can do now is accept a buyout offer from Pfizer or whoever. Big pharma will get this drug one way or the other and they will get it on the cheap. Our protagonist JZ previously stated that there were more companies interested in this drug than Amarin had employees at the time - 17 I think was the number. There is no way that has changed.

     

    The one big thing that HAS changed is that ANCHOR aint getting approval so forget about offers of $20, $30, $40, $100 or whatever. GSK bought Reliant and Lovaza for $1.7 billion. Vascepa is a superior drug, Amarin have 30+ patents and API supply already locked up. Is that worth $2 billion? That would mean a buyout share price in the region of $11.
    3 Nov 2013, 05:04 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    hey david did you read about the new cv drup that was approved by our friends the fda,,, I hub 20758
    6 Nov 2013, 02:58 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » This not over, I wrote an instablog that will be coming out soon with some perspective on path forward.
    22 Oct 2013, 09:14 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    could give us some insight on that fenofibrate drug that was approved for the indication mixed dislypidemia...I don't understand why the fda did this ? what the f ?
    6 Nov 2013, 02:57 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    I hub 20758,,,, please read
    6 Nov 2013, 02:58 PM Reply Like
Full index of posts »
Latest Followers

StockTalks

More »

Latest Comments


Posts by Themes
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.