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Steve Rosenman
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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
  • AF Backtracking, AMRN Will Be Approved On Time 161 comments
    Sep 24, 2013 10:48 AM | about stocks: AMRN

    The voice of non-relevance is back folks, and this time he is trying to spin his former prediction that AMRN Anchor decision will be delayed and not approved until more Reduce-It data is available.

    He is now blaming a potential government shut down (wont happen) on a delay for Adcom.

    Well, let's just look at it this way, in approx. 1 month we won't ever hear from AF again on AMRN..Because Adcom will pass on time and Anchor will be approved later in the year.

    Stocks: AMRN
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Comments (161)
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  • Attm
    , contributor
    Comments (35) | Send Message
     
    Stay humble, man... AF, at least on stock price performance-wise, predicted much better for the last 12 months.
    24 Sep 2013, 11:41 AM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    It's real difficult to predict negative results for biotech stocks, considering that most biotech startup drugs fail. Adam is a real Nostradamus there. If he takes the negative route, he'll be right probably 80% of the time.

     

    In this case, the drug didn't fail, but the company didn't get bought out and went it alone (so far), so the results were predictable at that point. If you're on your own, your stock will go by your sales, not future potential, trials, etc, any longer.

     

    In Amarin's case, Adam took a particular interest in bashing the drug and the company because they ignored him and treated him like he deserves to be treated... like he's worthless. As Steve mentioned, all the talk in the world won't make a difference soon.
    24 Sep 2013, 06:29 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    I'm really interested in understanding better this idea that I write critically about Amarin because management ignored me. Where did this idea take root? It's ridiculous on many levels. First, I've had plenty of interaction with AMRN, both on the phone and via email, and when I was bullish on the stock and after I turned bearish.

     

    Admittedly, AMRN no longer responds to my requests for information. That's their choice, but I don't hold it against them. They can talk to me or not, it makes little difference and I wouldn't base my opinion on a company on something as trivial as a returned phone call or email.
    25 Sep 2013, 02:43 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    Adam is so confident with his predictions because his influential friends at FDA and panel might have told him. May be he invited all the panel members to a party to say no.
    25 Sep 2013, 11:20 PM Reply Like
  • duanebecca
    , contributor
    Comments (3) | Send Message
     
    12:18
    Comment From Dawidoff
    Are your feelings still hurt that AMRN didn't call you back but they called back Jason Napodano regarding the patent issue? Haha... No, but seriously, you're not going to start bashing Amarin now because of that are you?
    12:20
    adam feuerstein:
    For those that missed my tweeter temper tantrum, i got #$%$ at AMRN for not returning my phone calls and emails about the patent issue on Weds. The reason i was #$%$ was not because of my ego, but it was because the company's management was talking to analysts and institutional investors but not communicating anything publicly for retail investors. i found that to be fundamentally unfair and told the company that.

     

    You can read the whole thing here,
    http://bit.ly/18rJjQG

     

    This doesn't sound like it doesn't bother you that they don't return your calls. This was from one of your blogs.
    26 Sep 2013, 08:37 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Seriously? Wow...

     

    Let's go back 2 years to refresh your memory. AMRN management was doing a terrible job communicating with shareholders. There was a lot of concern at that time about Vascepa patents, in part because the PTO was questioning the validity of AMRN's patent submissions, turning some of them away. Investors were getting information from the PTO's web site but AMRN management was saying very little publicly. They were talking some to sell side analysts but not to shareholders directly.

     

    My "temper tantrum" was an attempt to get AMRN to be more open about the patent-review process. I wanted them to provide information directly to shareholders and not speak only through analysts. I was advocating on behalf of retail investors!

     

    After my rant, AMRN opened up more, began sharing information publicly and more effectively. At that time, many AMRN retail shareholders thanked me for acting on their behalf.

     

    What you're doing now is re-writing history, claiming that I hold a grudge against AMRN because they refused to pick up the phone when I called. That's ridiculous.
    26 Sep 2013, 10:50 AM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    "My "temper tantrum" was an attempt to get AMRN to be more open about the patent-review process. I wanted them to provide information directly to shareholders and not speak only through analysts."

     

    You mean you wanted them to speak to you too, along with the other "legitimate" analysts who work for respected firms, not a rag like TS.com. Seeing as you're neither legit or a shareholder, they had zero incentive to provide you with any info - good for them!

     

    "I was advocating on behalf of retail investors! "

     

    OMG.....that made me laugh so hard my gut hurt!
    26 Sep 2013, 12:29 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    I call bs on that Adam. You are like a little school girl who got left out of a game of patty cakes. Nice call on Srpt the other day. You saw the stock down premarket so you put out a bash article only to be made into a total fool. Not long ago you were pumping SRPT based upon sales 6 years out. You really should get out of this business..
    26 Sep 2013, 02:23 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Next thing you know you will take some kind of credit for anchor approval. lol
    26 Sep 2013, 02:24 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    You must not have owned AMRN 2 years ago when there was good money to be made in the stock on the long side. Too bad.
    26 Sep 2013, 04:18 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    So angry... The alias explains all.
    26 Sep 2013, 04:19 PM Reply Like
  • duanebecca
    , contributor
    Comments (3) | Send Message
     
    But that's where the idea takes root, Adam. At one point, it very much bothered you that they didn't respond. Why not now? Wouldn't you want to know what the company thinks about your idea that the ADCOM will be negative? Isn't there anything else you'd like to know? Why doesn't it bother you any more?
    26 Sep 2013, 05:32 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    First of all I bought amrn at 3.50 the first time. Secondly I had 50,000 shares on the gap up from 8 to 16. The highest I bought was 15. My average purchase is around 6 as I loaded the boat again in the 5s. By the way I also bought 1000 contracts of MNKD when it was 2 and sold it all when it hit 8. As far as DNDN if I was embarrassed about my trading on it I would have changed my profile. You actually think I am still long on DNDN? I see your game plan is having an offense vs a good defense as you have none. I hope that helps.
    26 Sep 2013, 08:12 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    I agree. This guy Adam can send shivers down the company management. In most cases he knows more than the management of the company knows about because of his connections.
    30 Sep 2013, 05:26 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    @bull hahhahah really ?
    1 Oct 2013, 06:28 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Bullscan, I mean Adam...why don't you stop.
    2 Oct 2013, 04:21 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    Steve, I think you will ultimately get the last laugh but the reality is, AF has handed it to you over the last year.
    24 Sep 2013, 01:11 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I agree stock price is not where I thought it would be - but just to be clear, AF has not handed it to anyone - he has not offered one iota of knowledge relevant to the AMRN situation.
    25 Sep 2013, 09:03 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Not one iota of relevant knowledge? C'mon Steve, we both know that isn't true at all.
    25 Sep 2013, 02:45 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I believe it is (true) Adam. I have not seen you contribute one factual piece of scientific, regulatory or legal relevance on the situation and AMR-101 since you started writing about AMRN.

     

    Your personal attacks on me were even sillier and exposed you as being entirely non-relevant (when it comes to AMRN anyway)
    26 Sep 2013, 09:49 PM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    Steve,
    I know NCE is a sensitive subject, last time I read your board, you mentioned in April that Amarin was making some success with the exclusivity board, however the decision would be postponed to december timeframe due to resources. Has anything changed on this? Could we still get an update in Oct? Have you been in touch with anyone recently?
    24 Sep 2013, 01:54 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I have no knowledge about 'when' FDA will rule on NCE. I believe I stated before I am very confident about NCE because 1) science involved 2) GSKs apparent stance on what constitutes the active ingredients for Lovaza 3) contact with law firm familiar with the situation and their view that it is FDA timing and process, not AMR-101s validity that is holding things up.
    25 Sep 2013, 08:58 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    The vast majority of biotechs will never bring a blockbuster drug to market and many will fail completely. Developing new drugs and therapies is a capital intensive affair fraught with risk and subject to a lengthy, arduous and expensive regulatory process. Consequently, taking a consistently negative position on biotechs will most often make even the untalented look like a sage.
    I don't have a problem with AF's negativity but I think it is worthy to note that he NEVER has any skin in the game, long or short. I think this speaks to a lack of intestinal fortitude. Something akin to the kid on the playground that starts fights between other kids but never ever " trades" punches (no pun intended). AF's writings require very little talent, character or insight.
    So AF is right, sort of like a broken clock which just by virtue of its existence, is correct twice a day.
    SR on the other hand, has his hand in the game and has the moxy to take the risk. In this day and age, few it seems, see the difference.
    24 Sep 2013, 02:06 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    In terms of war, it is like being in a foxhole with someone while AF is at home trying to make moves on your lady....
    24 Sep 2013, 02:22 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » AMR-101 is a blockbuster, make no mistake. Today or tomorrow, will be blockbuster status.
    25 Sep 2013, 08:58 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    TheStreet's conflict of interest rules for employees prohibits me from owning (or shorting) any stocks.

     

    I assume you own AMRN. If you do and believe predicting the massive slide in the stock's value this year was so easy, then why the hell didn't you sell a long time ago?

     

    You could have taken the money invested in AMRN and flipped into a biotech ETF and made 50% so far this year. You wouldn't even have to pick an individual stock to ride on, just buy the NBI and make money. Yet you decided to own AMRN, so you lost 50% of your money. Interesting choice.
    25 Sep 2013, 02:49 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    The Street operates under rules and ethics? Who'da thunk it?
    25 Sep 2013, 04:01 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    you didn't answer my question.
    25 Sep 2013, 05:42 PM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    "You could have taken the money invested in AMRN and flipped into a biotech ETF and made 50% so far this year."

     

    But if he followed your advice from "13 Biotech Stock Predictions for 2013" he would have made a dumb move, right?

     

    4. The Nasdaq Biotechnology Index will close 2013 flat or down single digits.
    26 Sep 2013, 12:45 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    If you are replying to me, what question?
    26 Sep 2013, 04:39 PM Reply Like
  • Danburydude
    , contributor
    Comments (108) | Send Message
     
    Have to admit, the folks that tell the hit blogger what to say didn't get much bang for their buck. The price has rebounded quite quickly. I am still waiting for the article that says a meteor speeding towards Earth is going to delay ANCHOR approval .
    26 Sep 2013, 06:43 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Not really. His 'predictions' had no baring on where the stock price is now.
    24 Sep 2013, 03:02 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    you are wrong go read the article adam wrote on sept 9 2012. ever since pps has been falling and no nce and moreover he has more followers than you on twitter. that shows how irrelevant you and your articles are to everyone.
    2 Oct 2013, 06:25 PM Reply Like
  • Attm
    , contributor
    Comments (35) | Send Message
     
    VVUS doesn't look great...
    24 Sep 2013, 04:05 PM Reply Like
  • 5967241
    , contributor
    Comments (88) | Send Message
     
    Steve, what i've realized over a period of time is that AF is right most(99%) of the times. Now if he is backtracking, i will be a happy individual as an Amarin shareholder. At the end of the day it is about making some $'s back.
    24 Sep 2013, 05:23 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Agreed- I have been a shareholder for the past year and a half now, and I still haven't made any money... I like to think that eventually a payday is coming our way...
    24 Sep 2013, 10:13 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    Well, he needed something to bring down the share price, so govt. shutdown was a good excuse.
    25 Sep 2013, 05:52 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Steve, I'm not backtracking at all on AMRN. A government shutdown in early October, unless resolved quickly, will force FDA to postpone the Vascepa advisory panel. Same goes for other panels scheduled in October.

     

    I want the FDA to convene the AMRN panel as scheduled. It's going to be an exciting event. I'm planning on live-blogging. I'll be disappointed if I have to reschedule due to a gov't shutdown. Lastly, my prediction stands: The panel will vote against Vascepa in the Anchor patient population. I haven't changed my view or backtracked one bit.
    25 Sep 2013, 02:38 PM Reply Like
  • Samuel-
    , contributor
    Comments (103) | Send Message
     
    True.. AF never backtracked, he may have been quiet during the run-up but always kept his stand on a negative vote. Whereas Steve keeps saying it will pass. So yeah I agree about it being an exciting event.
    25 Sep 2013, 03:52 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Why do you THINK it will be voted against? All signs point to a positive vote. What do you know that EVERYONE else doesn't?
    25 Sep 2013, 04:23 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    I lost interest in AMRN after the last offering. At that point, the bear thesis became far less compelling. Many of the investors who were shorting AMRN at the time (those I spoke with) used the deal to cover quite profitably.

     

    I expected more of a run up into the panel, honestly. It's been rather muted. Perhaps we'll see more buying in October.
    25 Sep 2013, 05:45 PM Reply Like
  • cdvescio
    , contributor
    Comments (2) | Send Message
     
    "At that point, the bear thesis became far less compelling. Many of the investors who were shorting AMRN at the time (those I spoke with) used the deal to cover quite profitably."

     

    This translates to..... My friends at a hedge fund made a bunch of money of my completely biased, non scientific, nonsensical bashing of Amarin.
    26 Sep 2013, 09:58 AM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    So your buddies higher up covered...We always figured you were bashing for a reason. It is obvious. Off course we know you are not short. Its your little network that is or was short. You perhaps dont even know who they are as you are the soldier on the ground putting out your garbage.
    26 Sep 2013, 02:27 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    " I lost interest in AMRN after the last offering. At that point, the bear thesis became far less compelling. Many of the investors who were shorting AMRN at the time (those I spoke with) used the deal to cover quite profitably. "

     

    aka "my bashing articles every time a positive article came out on amrn helped my buddies with their positions."
    26 Sep 2013, 06:34 PM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Adam, I think you and Steve should live blog the Ad Com together...

     

    There's no data to support waiting for an outcome study, yet numerous scientific evidence supporting significant reduction in TG, non-HDL-C, Apo B, LDL-C, TC, and VLDL-C. No Afib or increase in LDL...with a risk safety profile literally better than Tylenol. The committee will look like total bafoons if Vascepa receives a neg Ad Com vote for a SPA drug meeting all primary and secondary endpoints with zero safety signals.

     

    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.

     

    Not sure how anyone could really see this ending with a negative vote. Steve get's a paragraph in your Oct 17 th article if Amarin get's an all thumbs up...what do you say?

     

    Williams
    25 Sep 2013, 06:02 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    FDA advisory panels are rarely drug coronations. They're convened to hash out concerns about safety, efficacy or the clinical meaningfulness of data.

     

    I expect the FDA to ask the panel to spend much time mulling over the latter with respect to Vascepa. The central question that remains unanswered, even with the positive Anchor study, is if omega 3s improve cardiovascular outcomes when combined with a statin. There is a lot of clinical evidence presented to date suggesting the answer is no, omega 3s don't reduce heart attacks, strokes, CV-related deaths, etc.

     

    The same can be said for other drugs such as niacin.

     

    The Reduce-It study is enrolling well and will provide definitive answers in 2016, a relatively short period of time to wait. My bet is the FDA and the panel agree that waiting for CVOT data before expanding Vascepa's label is the correct action to take.
    25 Sep 2013, 08:12 PM Reply Like
  • Dmlcento
    , contributor
    Comments (9) | Send Message
     
    AF, have you gone back and looked at all the Endo Ad Coms that took place in 2011, 2012 and 2013, because I have. Everyone, except one gave approval to the drug investigated. Quite a few people have said that Kaul and Prochan(sp) will vote against Vascepa because of the outcome study issue. Even though they both discussed outcome studies in each AdCom that they were involved in, they both voted to approve in each of the Ad Coms. Efficacy above end points, safety as good as placebo and they are already doing an outcome study. Do you still think they are going to vote no this time?
    25 Sep 2013, 08:59 PM Reply Like
  • pwt750
    , contributor
    Comments (67) | Send Message
     
    I find it irrational that the FDA would make it a condition that AMRN conduct a hugely expensive outcomes trial, and then cut off the company from the means of support to finish that trial.

     

    Given the excellent safety signals of EPA, and with the only long term trial of an EPA-only drug returning positive results, along with the fact that drugs failing an outcomes are still on market and widely used, I hope that FDA is indeed rational.

     

    It will be interesting to see if anyone on the committee has an agenda, or worse conflicted interests, to taint the logic. When you say "the panel agree[s] that waiting for CVOT data before expanding Vascepa's label is the correct action to take" it shows the difference between a 'journalist' and a reporter. A bias, and a seemingly bitter one at that, having seen the derision you save for AMRN and it's stockholders. I hope no one you care about would be required to wait 2 more years, they may not have, to see if taking a clean profile drug is any good for them. Not to mention , although not robust, the additional data from all those regular patients would help settle the questions.

     

    Let physicians and patients decide if they have time to fritter around a few years.
    25 Sep 2013, 10:18 PM Reply Like
  • louieblouie
    , contributor
    Comments (23) | Send Message
     
    i work in DC and will be happy to attend and blog on Adam and Steve while they blog on Amarin. Let the games begin.
    25 Sep 2013, 10:31 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    The biggest risk to my AMRN panel thesis is Vascepa's safety. Panelists could vote to recommend approval because the risk that Vascepa does harm is low. In other words, "We don't know if patients will actually benefit from Vascepa, but the drug is safe so approve it now why we wait for Reduce-It results."
    26 Sep 2013, 06:50 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    I have no derision for AMRN or its shareholders. For more than a year, I've told you repeatedly -- warned you -- that the stock was going to fall. That's exactly what happened. I've been trying to help you.

     

    One more point: Vascepa is not the life-saving drug you think it is. Fish oil has become less important to docs, not more.
    26 Sep 2013, 06:52 AM Reply Like
  • hipfreejazz
    , contributor
    Comments (9) | Send Message
     
    Steven Ketchum's (Amarin's President of Research & Development & SVP) comments during Amarin Corporation's Q2 2013 Earnings Call August 8, 2013:

     

    "As a reminder, the ANCHOR study was conducted under Special Protocol Assessment Agreement with the FDA.

     

    This is an extra step that we took with the FDA before commencing the ANCHOR study to ensure that we had a written understanding with the FDA as to what they required for approval of the ANCHOR indication. We believe that we have achieved all that is required. More specifically, we achieved all of the primary and secondary clinical endpoints of the study.

     

    For clarity, the SPA and corresponding regulatory discussions in no way require us to have the outcome study completed for the sNDA to be accepted for review or for the ANCHOR indication to be approved. We announced in Q1 that over 4,000 patients were enrolled in the REDUCE-IT study and that we submitted the sNDA for the ANCHOR indication. In Q2, the FDA accepted the sNDA for review.

     

    As is typical, the FDA provided Amarin with a letter that notified us of this acceptance. This Day 74 Letter is in response within 14 days of the initial 60 day review period of the application is commonly used by the agency to preliminarily flag any early and potentially important review issues. The Day 74 Letter for the ANCHOR sNDA included no such surprises. In particular, the letter did not, in any way, suggest that the agency plans to reset its requirements for approval of the ANCHOR indication.

     

    Some investors have interpreted the AdCom as implying that the agency intends to change the rules for Amarin with respect to the status of the REDUCE-IT outcome study. We have not seen evidence of such a change. We had considerable discussion with the agency over what constituted substantial underway for the outcome study and during these discussions, never did they suggest changing their requirements.

     

    Rather, we believe that they appreciate the broad undertaking that we are pursuing with REDUCE-IT and the scientific seriousness with which we are conducting the study. At this point, FDA has accepted our sNDA for review, which reflects to us that they agree that the outcome study is substantially underway."
    26 Sep 2013, 08:22 AM Reply Like
  • duanebecca
    , contributor
    Comments (3) | Send Message
     
    .... as prescriptions increase by the week. Where will climb stop if less Docs are prescribing?
    26 Sep 2013, 11:18 AM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    "Fish oil has become less important to docs, not more."

     

    So this is why TEVA has sought to invalidate GSK's Lovaza patents and why BASF has purchased Pronova and why a state of the art manufacturing plant is being constructed in France?
    26 Sep 2013, 11:52 AM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    "One more point: Vascepa is not the life-saving drug you think it is."

     

    That statement clearly shows your lack of knowledge about how EPA works - V is a ground breaking drug - proof is already out there via the JELIS study if you bothered to do any research, plus a raft of new research papers published on the efficacy of Epadel in reducing CV/stroke risk.

     

    " Fish oil has become less important to docs, not more."

     

    Vascepa is not "fish oil" - it's pure EPA - ignorance is showing once again, as is your bias against AMRN.
    26 Sep 2013, 01:14 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Haha...
    One problem with me live blogging. I have a real job.
    26 Sep 2013, 05:33 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    Shhh... don't give Adam facts, he doesn't know how to handle them.
    26 Sep 2013, 06:38 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    trying to help us... HAHAHA... You've been trying to help your buddies interests, plain and simple.

     

    Funny how you always lump Vascepa in with every other fish oil, otc, lovaza, generics, etc... when it's been proven that's it's far different from otc, more effective and safer than lovaza, etc. You love to lump them all together when Vascepa reacts differently. It doesn't cause a-fib like lovaza and epanova can. It's safer, more effective, and is by far the better product.

     

    What you like to ignore is Vascepa's anti-inflammatory abilities. This is huge for diabetes sufferers, as well as other inflammatory diseases. If anything, it's MORE important than it ever has been with how many suffer from those diseases....along with the TG reducing indications.
    26 Sep 2013, 06:45 PM Reply Like
  • Danburydude
    , contributor
    Comments (108) | Send Message
     
    Drum roll please................... the above comment at 6:50 a.m. is the backtrack. The ADCOM is about expanding for ANCHOR, not approval for a drug with statins. I believe the ADCOM for ANCHOR with statins will be in a room down the hall. Maybe the hit blogger can take a picture of all the empty chairs in that room to increase the knowledge of the investing public.
    26 Sep 2013, 06:54 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » You are so wrong AF. Most studies do show relevance, the most direct is JELIS on EPA for AMR-101.

     

    Quit reading the fly by night articles that come out on Omega-3s and start doing real scientific due diligence. You will find yourself changing your sentiment quickly.
    26 Sep 2013, 09:49 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Said from a doctor himself (yeah right)
    26 Sep 2013, 09:49 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    so is that what the panelists are going to say ,,, that patients may not benefit from v.. ? im not very smart .. though .. from what ive read I think that patients have benfited from v... right ?
    27 Sep 2013, 08:42 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » you're wrong, just like you were about the delay. sorry.
    2 Oct 2013, 12:26 AM Reply Like
  • KCSVEN
    , contributor
    Comments (35) | Send Message
     
    Omega 3 studies are irrelevant to Vascepa, there has been only 1 known study on cardiac events and pure EPA which did show a benefit. Even the Omega 3 studies done were low dose and included DHA so are irrelevant to Vascepa. Statins have ZERO effect on increasing lifespans, meaning you die the same time whether on statins or not yet they sell 20 billion dollars based on a very small percent of people that actually get any benefit.
    Comparing the bad Omega 3 studies to JELIS or Vascepa is crazy and the committee members are not ignorant to science.
    So Zero studies showing EPA is not beneficial in reducing cardiac events and one showing it is beneficial. So if that is the central question then it's easily answered in the affirmative for Vascepa.
    2 Oct 2013, 11:31 AM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    i agree. i am sure you are tending the panel meeting in person. i think you should raise all your questions to the panel during the 1hour public comments window.
    2 Oct 2013, 06:26 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    AF, so you think the FDA decides to wait 2 years? The problem I see with that is Vascepa is safe and as BiotechBillionair wrote.... there is evidence supporting significant reduction in TG, non-HDL-C, Apo B, LDL-C, TC, and VLDL-C. So the FDA can potentially save lives now and they decide to wait because why? Vascepa is not an omega 3 so there is no clinical evidence that Vascepa doesn't reduce CV-related deaths. Doesn't make sense that they would wait two years but who knows.
    25 Sep 2013, 08:54 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    See my comment above. This is the biggest risk to my negative panel thesis.
    26 Sep 2013, 06:53 AM Reply Like
  • JohnCappello
    , contributor
    Comments (39) | Send Message
     
    AF, This admitted weakness in your position warrants further illumination.

     

    Let’s consider that the target population for Anchor are Diabetics with dyslipidemia and clearly the group who stands to gain the most from an expanded indication assuming it’s effective. So what is at stake here?

     

    There are 28 million Diabetics in the US alone, clearly a staggering number.

     

    Heart diseases and stroke are the No. 1 causes of death and disability among people with type 2 diabetes.

     

    In fact, at least 65 percent of people with diabetes die from some form of heart disease or stroke.

     

    •About 600,000 people die of heart disease in the United States every year–that’s 1 in every 4 deaths from CVD.
    •Heart disease is the leading cause of death for both men and women. More than half of the deaths due to heart disease in 2009 were in men.1
    •Coronary heart disease is the most common type of heart disease, killing more than 385,000 people annually.
    •Coronary heart disease alone costs the United States $108.9 billion each year.3 This total includes the cost of health care services, medications, and lost productivity.

     

    Any way you look at it, the Anchor population is huge, and the risk of death by heart disease is significant, and especially high for Diabetics. The Anchor trial was powered for Diabetics with 70% of Anchor participants Diabetics with Dyslipidemia and that is reflected in the composition of ADCOM panel members.

     

    So let’s look at what we know. Vascepa lowers most, ( if not all) key CV lipid markers; non–HDL-C, VLDL-C, Lp-PLA2, Apo B, TC, HDL-C, VLDL-TG, and hsCRP .

     

    Source: http://bit.ly/19BUWET

     

    In light of this data , it seems clear that the 28 Million Diabetics in the US at risk of CVD and morbidity from CVD will be directly impacted if the panel denies access to Vascepa assuming Reduce it results confirm positive effect on reducing CV events.

     

    Assuming “Reduce it” produces similar results as JELIS in the cohort (~50% reduction ) How many lives people would be spared or improved over the next 2 years ? Anyway you look at it , that number is a big and a thus a potentially serious consequence for any panel to deny it .

     

    If as you suggest, the panel votes to not approve Vascepa and instead wait 2 years, it is denying theraputic access to a very large number of people who are at serious risk but with zero upside from avoiding Vascepa since its proven to have Placebo like side effects. What possible benefit would the panel be achieving by denying access for the population? What are they saving them from? Potentially false expectations, perhaps? That is the only downside risk I see.

     

    Even if Vascepa proves to deliver only 25% reduction CV event reduction ( vs. 50%+ of JELIS Cohort) it suggests ADCOM would be irresponsible to delay it since 25% reduction of CV deaths among 28 million Diabetics is a very big number over 2 years .

     

    At worse case, and there is no significant reduction, then we have millions of Diabetics on Vascepa with improved lipid markers, less chronic inflammation with lower LDL-C but no reduction in CV events. How bad is that scenario vs. hundreds of thousands who died who otherwise be alive?

     

    I’m sure that any one of us with a diabetic family member would never choose to deny access to Vascepa especially with knowledge of its placebo like side effects

     

    I can't see one vote being cast against approval and silly to think otherwise
    26 Sep 2013, 08:40 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Vascepa is a diabetes drug now? Hmmm...
    26 Sep 2013, 07:33 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    You don't seem to have a problem with Lovaza stepping outside it's approved realm???
    26 Sep 2013, 07:58 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Hey Adam. I am a diabetic. Do you know what causes most of the complications from diabetes? You probably do not. Do you know what Vascepa fights? You must not.
    26 Sep 2013, 08:14 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Actually yes Adam. Today I visited my doctor who is one of the top endocrinologist in the USA and guess what he gave me a prescription for? Prescription to fight inflammation as there are several dozen diseases that are caused by inflammation. No I do not have super high trigs so I did not get the prescription for that. Yes the doctor was aware of Lovazas warning and that it caused higher cholesterol. Just a matter of time...You have a lot to learn. I think I am a little bit more familiar with Diabetes than you are.
    27 Sep 2013, 08:57 PM Reply Like
  • JohnCappello
    , contributor
    Comments (39) | Send Message
     
    Diabetics on a statin with mixed Dyslipidemia is absolutely the sweet spot of the anchor pop. Frankly, the fact you were not aware of this concerns me. And this profile made up 70% of Anchor trial.

     

    Why do you think the panel is made up of Endocrinologists? 3/4 of Diabetics die of cardiac issue and mixed Dyslipidemia (especially when on statin already) is a significant risk that is going untreated. Which is why the lowering all key markers (inflammation is key among them) is so important. I respectfully recommend you do some reading on this under served pop. at CV event risk.
    28 Sep 2013, 06:31 AM Reply Like
  • JohnCappello
    , contributor
    Comments (39) | Send Message
     
    Adam,
    Given the long fight you've had with us AMRN longs, I don't expect you to concede my point that Anchor's benefical focus is Diabetics and thus will be approved by ADCOM , but I'll try nonetheless.

     

    As you well know, Mixed Dyslipidemia can be two or more lipids out of wack, and what is usually seen is TGs high, plus one (or more) other lipids high. The segment of the US population most adversely affected by mixed dyslipidemia are the 28 Million Diabetics in the US .

     

    Its not at all that difficult to see that the primary concern of Endocrinologists is reducing the risk of CVD among their Diabetic patients since cardiac issues make up between 68% - 75% of the cause of death among Diabetics.

     

    If you review the lipid guidlines for Diabetics, its usually <100 TGs ) which are more aggressive targets than for non diabetics so clearly lipid markers are a target for clinicians treating diabetics .

     

    Note this article (link) was published this week by Medscape"pulling the alarm" on Heart issues in Diabetics.

     

    http://bit.ly/18BqOcJ

     

    This is just one example that the need to address CVD risk in Diabetics is becoming an alarming and costly health issue. Vascepa is poised to be adopted as a key drug in helping Diabetics reduce key lipid markers, with reduction of inflammation among the most critical in preventing the onset and/or progression of CVD. And, it is for this reason that the ADCOM panel (made up of mostly Endocrinologists) will be focusing on the needs of Diabetics when assessing Vascepa and the Anchor indication. . A drug that has acehieved strong clinical results coupled with an incredible saftety profile.

     

    In further support of my position I offer several recent studies that have been submitted and accepted by ADCOM showing, for example:

     

    EPA increases insulin sensitivity and that EPA improves gylcemic control
    http://1.usa.gov/18BqOcL

     

    EPA increases Interleukin-10 Levels of Peripheral Blood Monocytes in Obese Patients With Dyslipidemia
    http://bit.ly/18BqQ47

     

    EPA improves insulin sensitivity
    http://1.usa.gov/18BqQ46

     

    Vascepa is a powerful adjunct to diet for Diabetics and will undoubtedly become a foundational therapy and the standard of care among those suffering from Diabetes. In summary, Vascepa is not intended to be a drug to fight Diabetes itself, but it will be a drug found in the medicine cabinet of 10's of millions of Diabetics.

     

    Get on the train Adam, its not too late :- )

     

    Regards, John
    29 Sep 2013, 09:09 AM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Adam,
    Niacin is not fish oil. Fish oil is not Vascepa. Why do you ignore JELIS? JELIS sub group and 50% reduction in cardiovascular outcomes is undeniable. If the FDA wants to see the results of REDUCEIT, they'll approve Anchor to support the study costs. Otherwise, Amarin cuts study to penatrate Very High Trigs to Lovaza levels, business before science...the FDA should understand this concept.

     

    Fish oil does crap for CV outcomes, why? EPA blood levels
    Vascepa's EPA levels are 30 times higher than Lovaza, and 50+ higher than OTC ?toxic? fish oils. EPA is "essential" to the science of eicosanoids and inflamation. Over a year ago I though Amarin was total BS, until I studied the science. I could now teach a college level course on the subject, Vascepa will be the number one seller in the next 5 yrs, sell over $10 Billion in one year and take the top spot form Lipitor in life time sales. Perhapse you should research Dr. Sears.

     

    Jokes on me if I'm wrong...a risk I'm taking.

     

    Williams
    25 Sep 2013, 09:26 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Hate to break the bad news to you -- again, but most docs believe fish oils, omega 3s, lovaza, vascepa are inter-changeable.

     

    Vascepa's commercial launch has been a big disappointment for this very reason.
    26 Sep 2013, 06:54 AM Reply Like
  • JohnCappello
    , contributor
    Comments (39) | Send Message
     
    AF, I agree this was an accurate observation by you 8 months ago. In fact, my direct interactions with Cardiologists support your comment that in early 2013 Vascepa was seen as just fish oil.

     

    But let’s flip 8 months later to a week ago and a top Cardiologist tells me he is now writing for Vascepa, understands the role of EPA, dose dependency and states that DHA does nothing to benefit the CV system. In fact he confirms he is writing Vascepa scripts “on-demand” to those at risk (past CV events ) even when TGs are under 200. Another words, "reduce it" indication. Let that sink in.

     

    But to your point, another Card in the exact same practice recently dismissed it recently as simply Fish Oil to my girlfriend an RN. He simply never had the time to read, and had somehow was able to evade the knowledge even when another Physician in his practice had already adopted Vascepa. So here we have two Cards, both unaware of therapeutic value from 4gm of pure EPA eight months ago, to now, where one Card is writing Vascepa Rx while his partner s only beginning to learn of it. In my mind, the question isn’t, will Docs adopt Vascepa, it’s when they do.

     

    It’s a small sample size, but it’s suggests that the word is getting out and the differentiation of Vascepa is finally sinking in . It seems to me that Amarin is turning the corner with differentiation finally being known and appreciated by clinicians. If we start seeing Scripts accelerate, then I think my assertion can be concluded to be accurate - as much as yours was 8 months ago
    26 Sep 2013, 07:43 AM Reply Like
  • Dmlcento
    , contributor
    Comments (9) | Send Message
     
    Would you mind doing some research on the difference between "fish oil" and Vascepa, and there is a big difference, and then write an article illuminating the difference for your audience?
    26 Sep 2013, 09:13 AM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    Only the uninformed lump them all into one category. Seems you fit that group.
    26 Sep 2013, 06:51 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » 'Most docs" ...really Adam. And you are in their circles, a Street.com editorial contributor? Dude, reality check is needed.

     

    I can promise you I know a heck of a lot more opinion leading docs than you (I was on ONN advisory board by the way - read 30,000 docs and nurses) and I can tell you your sentiment is fallacy.
    26 Sep 2013, 09:49 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    Steve,
    I work in a dyslipidemia clinic run by clinical pharmacists in direct collaboration with physicians. According to Adam, "Most docs" really, I work with them on daily basis and we see pts. with mixed dyslipidemia profiles, non-compliant diabetes pts. (A1C way above 7.5 to 9, high ldl, TC, TG), pts. with proteinuria, uncontrolled HTN. These are the complex profiles of pts. we work with on daily basis and lovaza is currently prescribed for these pts. with other meds to prevent progression of their disease. What kind of doctors do you communicate with that tells you that vascepa is just a fish oil? However, physicians we work with dont' present the same picture about vascepa that you are trying to create.
    Vascepa will be approved for anchor and will be a blockbuster.
    27 Sep 2013, 12:46 AM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    Why haven't you switched your Lovaza patients to Vascepa if you're so enlightened?
    28 Sep 2013, 11:33 AM Reply Like
  • pwt750
    , contributor
    Comments (67) | Send Message
     
    sts; regarding your brusque comment - perhaps punjabi does not RUN the clinic, he is apparently striving to enlighten (drag) the powers that be to the new paradigm (into the modern age) . Beyond that I presume you will get a first hand reply.
    28 Sep 2013, 08:15 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    STS66: Fibrates are the first cheap therapy on formulary, then lovaza and vascepa. Do you know how insurance companies work? If not then do some research online and find out how long it takes for a brand drug to get on the formulary list. Doesn't happenn in days or weeks but takes substantial amount of time to have a brand drug on formulary list. Vascepa is not on the formulary list the institution we work for but things will change in the near future as recommendations are there for having vascepa on the list since majority of pts. we see have diabetes as well. Once vascepa gets on the tier 2 program, yes we will prescribing vascepa as the preferred therapy compared to lovaza or fibrates.
    29 Sep 2013, 11:04 AM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    Ah, the lame "push it off as long as possible" insurance companies claim another victim. Doesn't make sense to me, as the cost of L and V is about the same, and V is clearly superior to L. My insurer put V on T2 for commercial customers in July but won't put it on T2 for Medicare plans until Jan 1, 2014 - again, the meaningless diff in cost makes no sense for delaying coverage. They review the formulary monthly, but I believe most major plans do it quarterly or bi-annually. Thanks for the response.
    30 Sep 2013, 02:52 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    hey steve dude u need reality check with your blind predictions.
    2 Oct 2013, 06:28 PM Reply Like
  • Teebonekrusher
    , contributor
    Comments (4) | Send Message
     
    Adam, will you please let us know how many empty chairs there are at the adcom meeting? I remember you doing the same at a investor conference Amarin presented at some time ago. Those are the types of insights you offer which many of us find so meaningful.
    25 Sep 2013, 10:05 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Had you taken my comment about AMRN's half-empty room at the JP Morgan conference in January even semi seriously, you'd have saved yourself money this year.
    26 Sep 2013, 06:57 AM Reply Like
  • pwt750
    , contributor
    Comments (67) | Send Message
     
    af- as long as we are strolling down memory lane,
    I thank you for warning me off of those pre-data-selling data-mining venue-pickin no goods at ACAD. I thank me for not listening to you.

     

    Actually the parallels are even more striking. ACAD had lots of eggs thrown at it it while re-running a more insightful Pima. AMRN, while its re-running an improved JELIS. So predictable.
    26 Sep 2013, 11:31 AM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    What about your prediction that AMRN would be bought out in 2012? Should we have taken that one semi-seriously?
    26 Sep 2013, 06:52 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    I hope you were able to clear you head the other day with your SRPT debacle and already started your back paddling operation saying that AMRN might just be approved for anchor due to its safety. Typical Adam move. Must be tough working for a penny stock company making a 5 figure salary while many of us here are killing it in this market. Like you said you are not allowed to own stocks. Once again you got your nose pressed up against the glass looking in from the outside. Can you remind me again the potential of Srpt revenue 6 years down the road...as you pumped it to watch it crater only to start bashing it at the bottom. lol....nice one.
    26 Sep 2013, 08:31 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    So what would be the downside to approving Anchor? None. Case closed. The stock price suffers because AMRN will GIA for Anchor. BP not willing to pay up until Reduce-it.
    25 Sep 2013, 10:22 PM Reply Like
  • lingkui
    , contributor
    Comments (11) | Send Message
     
    AF,

     

    If you were FDA, would you rather an on-label Vascepa script or an off-label Lovaza script (which might cause AFib and increased LDL by 45%) for treating high trig. patients?
    25 Sep 2013, 10:37 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Docs Rx Lovaxa off label for the Anchor indication already. Ask around.
    26 Sep 2013, 06:57 AM Reply Like
  • lingkui
    , contributor
    Comments (11) | Send Message
     
    AF, thanks for confirming the Lovaza off label situation. So If you were FDA, would you rather doctors write an on-label Vascepa script or an off-label Lovaza script (which might cause AFib and increased LDL by 45%) for treating high trig. patients? Why would the FDA want patients to continue to suffer from AFib and increased LDL? Did you get a chance to comment on what I posted below? I assume no comment means you agree with me, right?
    26 Sep 2013, 08:36 AM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    that was his point, haha
    26 Sep 2013, 06:55 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Yeah, they don't get paid though.
    26 Sep 2013, 09:50 PM Reply Like
  • lingkui
    , contributor
    Comments (11) | Send Message
     
    AF, I respect your opinion. However, Vascepa can't be described just as omega-3. It should be viewed as the only FDA approved pure EPA molecule (hence NCE). If Vascepa reduces MACE but FDA wait for CVOT before ANCHOR approval, it might lead to unnecessary loss of life (James Gandolfini?). FDA should approve ANCHOR in December and let patients and doctors decide to prescribe Vascepa or not. On the other hand, if ANCHOR approved before CVOT results which then fail in 2016, that could lead to unnecessary monetary loss, i.e, copay. What's more important? $1,000 of copay spent over 3 years or potential life saved?

     

    Given Vascepa's safety & efficacy, let patients and doctors decide for its usage, not you or the FDA. Imagine if any of your friends & family suffer from MACE in next 3 years due to ANCHOR not approved, you'll be really mad at the FDA if REDUCE-IT prove successful in 3 years.
    25 Sep 2013, 10:43 PM Reply Like
  • bakemann
    , contributor
    Comments (33) | Send Message
     
    adam,
    with all due respect, if there is no clinical meaningfullness to lowering try's, why did the fda approve lavaza and vascapa?
    25 Sep 2013, 11:10 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    I hope that guy gets a heart attack then he will understand the importance of vascepa and the urgency we have for preventing and reducing various cvd markers.
    25 Sep 2013, 11:17 PM Reply Like
  • samilyn05
    , contributor
    Comments (3) | Send Message
     
    I wish AF would respond to this question by bakemann:

     

    "adam,
    with all due respect, if there is no clinical meaningfullness to lowering try's, why did the fda approve lavaza and vascapa?"

     

    I have the same question for AF. Isn't Anchor about treating triglycerides? Are doctors still treating high trigs? If so, then why not use Vascepa? Does AF and others believe that the FDA is incorrect with their label warnings with Lovaza? Do they think the Anchor data is not sufficient? Do they think the safety profile of V has been incorrectly stated? Why would FDA wait for RI data when trigs are already being treated with many other drugs?
    I would truly appreciate answers to these questions by the many who do not think Vascepa is a good drug for mid level and high trigs.
    I will stay long Amarin and cry foul if Vascepa does not get approved for Anchor.
    27 Sep 2013, 06:01 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    The Journal of Atherosclerosis and Thrombosis

     

    " Eicosapentaenoic Acid (EPA) Reduces Cardiovascular Events: Relationship with the EPA/Arachidonic Acid Ratio"

     

    Published September 18th, 2013

     

    Nuff Said. The currently accepted upper limit for trigs is 150 mg/dl. I assume this limit is not arbitrary. Vascepa lowers trigs effectively and safely. Amarin didn't set this limit. The medical establishment did. The sNDA is about lowering trigs. It is not about cardiovascular events. That is what the sNDA for postive results of a REDUCE-IT trial will be for. However, there is plenty of evidence that EPA does in fact reduce cardiovascular events, should the panel want to go there. There is no good logical reason to postpone approval in the ANCHOR indication. The decision to prescribe Vascepa for this indication should be left to the discretion of individual doctors. It would be extremely poor policy to deny doctors and patients the choice. If the FDA allows a panel to stonewall Amarin for no good reason, it will have lost ALL credibility.
    26 Sep 2013, 12:38 AM Reply Like
  • AFKnowsNothing
    , contributor
    Comment (1) | Send Message
     
    Take heed intelligent investors before you fall for one of AF unfounded articles and end losing as the stock PPS goes up. I have several experiences having relied on AF as a source for my DD and selling based on articles he skillfully writes to throw you off your game. If you are in doubt read this article he wrote about VIVUS where he convincingly suggest (plants the bad seed in your head) that because insiders are selling they must know that they will not be approved and we all know the outcome
    Article: Vivus Insiders Sell Stock Ahead of Crucial FDA Approval Decision by AF. I have so many examples of similar articles fortunately I no longer rely on AF as one of my sources to do my DD. Do not be fooled. Do your DD.
    26 Sep 2013, 12:46 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    Here's a link to the VVUS article you refer to:

     

    http://bit.ly/18rvWjt

     

    Have you kept up with VVUS' troubles since Qsymia was approved. This article reads prescient. You should be thanking me.
    26 Sep 2013, 06:59 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    BTW, Vascepa/Pure EPA is not simply "Omega 3s" or "Fish Oil". That much should be obvious.
    26 Sep 2013, 12:50 AM Reply Like
  • BiotechWill
    , contributor
    Comments (175) | Send Message
     
    Although I enjoy the AF bashing as a matter of juvenile fun, I'll stick to the holes in his denial thesis. First and foremost, he probably hit the nail partially on the head when he talks about the safety being of zero concern, and leading to approval. The other half of that equation is quite simply that Vascepa demonstrates efficacy (and superior efficacy at that) in lowering triglyceride levels - which again, is the indication it is seeking.

     

    I actually can see the possibility of discussions of efficacy in CV reductions coming up, but I see them as having no impact on the outcome of any AdComm votes. I think that the studies that support the possibility of CV event reductions are put together better than the weird meta-analysis/low dose/non-applicable studies indicating otherwise.

     

    What it boils down to, and as I've said before - there is no reason for the FDA advisory panel to not recommend the ANCHOR panel based on the questions that should be asked. It will be first in class in efficacy and in safety - period.
    26 Sep 2013, 08:01 AM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    If "juvenile" means being dead-on right about AMRN going into Vascepa approval and after, then I guess I'll wear the crown proudly. Which adjective should we attach to you?
    26 Sep 2013, 08:06 AM Reply Like
  • BiotechWill
    , contributor
    Comments (175) | Send Message
     
    LOL. I actually meant the people "engaged in AF bashing" as opposed to the "bashing AF is engaged in" - I suppose I could have been clearer by the term "AF bashing."

     

    But, then you had to go and get all personal, despite our recent niceness on Twitter... so I guess in terms of me, I'll suggest the following adjectives: Cool, Nerdy, Fun, Level-headed, Verbose, Witty, Charming, Patient, Intelligent, Charismatic, and Playful.

     

    NOW, when someone attempts to play nice with you and respectfully disagree with your opinion, don't go jumping to conclusions and get all 4th grade playground on them. You have indicated at least one hole in your hypothesis, and one that I find to be a rather large one, and as I have stated previously I also do not think this panel will be as much about REDUCE-IT/CV events as you seem to think. I have also indicated what I find to be other holes in your logic, so again, it will be interesting moving forward.

     

    Someone will be right, and someone will be wrong. Beyond that, time will tell... unless you have some inside information that I do not, in which case feel free to share.
    26 Sep 2013, 08:21 AM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    lovaza is a billion dollar drug, period, vascepa will be. AF says that docs don't believe in fish oil, while most patients with moderate to high trigs on statins are taking fish oil to supplement statins

     

    Vascepa data shows 1st in class, outperforms lovaza

     

    nuff said
    26 Sep 2013, 09:42 AM Reply Like
  • cdvescio
    , contributor
    Comments (2) | Send Message
     
    Crude oil is jet fuel as fish oil is to Vascepa.
    26 Sep 2013, 10:08 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Adam - Let me reitertate the request from Dmlcento. I challenge you to write a well researched, documented and factual piece on the differences between Vascepa and "fish oil" including issues surrounding dose dependency, the effects of pure EPA on atherosclerotic plaque, the reasons that Crestor has been successful and the parallels with Vascepa in terms of hsCRP reduction etc etc.

     

    If you want to expand your audience and garner support and more respect, this would be the way. I'm surprised you haven't done this already. You're a sharp guy. Your motives are what I question. Controversy may increase readership but why not throw a curve ball now and again?
    26 Sep 2013, 03:57 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    And if i disagree with your premise?

     

    I have a large audience already and plenty of respect from peers and readers. Even this small band of AMRN diehards who say they hate me can't stop responding to my comments.

     

    Thank you. I will never take you for granted.
    26 Sep 2013, 04:26 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Haha. Little adam didn't like your response. Total deflection.
    26 Sep 2013, 04:42 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    No, I'm telling him that I disagree with the premise of his question. I don't believe there's much difference between Vascepa and other fish oils.
    26 Sep 2013, 07:34 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    There is about as much similarity between fish oil and vascepa as you and a bald eagle. Ohh crap I stand corrected. You are correct there is no difference. lol
    26 Sep 2013, 08:17 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    That tells me about your knowledge about science, pharmaceutics and drugs overall.
    26 Sep 2013, 09:23 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    Adam,
    Provide one legitimate research backing your points which I think you don't have. I'm glad the company didn't responded to you. The company is busy conducting their company operations then (you know what).
    26 Sep 2013, 09:35 PM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    Adam,
    If you don't care, why you reply back. Why you even come here and make your point without any factual data or research?
    26 Sep 2013, 09:35 PM Reply Like
  • david22hughes
    , contributor
    Comments (237) | Send Message
     
    In August 2011, Amarin announced that it had reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) agreement for the design of the previously described cardiovascular outcomes study of Vascepa formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). In REDUCE-IT, Amarin will evaluate the effectiveness of Vascepa in reducing the first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus Vascepa. All subjects enrolled in the study will have elevated triglyceride levels. Amarin will be responsible for the study which will be conducted internationally. Amarin estimates that the study will require approximately 8,000 patients and take around 6 years for completion. They just announced that 6,000 patients have been enrolled so far.

     

    Once REDUCE-IT was substantially underway, Amarin believed that it would have met all of the requirements to request approval of Vascepa for treating the mixed dyslipidemia patient population studied in the ANCHOR trial. In April, the FDA accepted their sNDA submission for the ANCHOR indication and they have been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.

     

    On June 19th Amarin was informed by FDA of an October 16th Advisory Committee Date in connection with the sNDA for Vascepa in the ANCHOR indication. This is standard procedure.

     

    This quote is from the recent press release announcing the ADCOM;

     

    "For key first-in-class indications, an FDA advisory committee meeting is expected, and this public forum will be an important opportunity to discuss the ANCHOR data, which demonstrated Vascepa's unique potential as an adjunct to diet in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) and mixed dyslipidemia," said Eliot A. Brinton, MD, FAHA, FNLA, Director of Atherometabolic Research, Utah Foundation for Biomedical Research, and President, American Board of Clinical Lipidology. "Currently, many of these patients are receiving another prescription omega-3 which is not indicated for this disorder. Having instead an omega-3 product which lowers LDL-cholesterol in addition to triglycerides, has tolerability comparable to placebo, and is FDA-approved for use on top of statin therapy would be a welcome addition to the physician's armamentarium for comprehensive lipid management."

     

    The other drug referred to is the inferior Lovaza which you will recall has been selling around $1 Billion annually.
    27 Sep 2013, 12:04 AM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    So, would that mean you are not someone manipulating the market for your friends and cohorts, but instead someone who is warning all the longs about investing in a product that is nothing more than an OTC fish oil?
    28 Sep 2013, 08:58 AM Reply Like
  • amrnBagHolder
    , contributor
    Comments (73) | Send Message
     
    That's why you are not a doctor.... Now, I will admit that getting that message to doctors may be difficult but when presented with the proper info they will see the difference. When you (AF) are presented with the proper info you do not. Again, this is why you write investment columns and don't prescribe medication. I think you point out AMRNs biggest hurdle however. Can they get the message out that this is not FISH OIL. If they can't, this will never be close to a blockbuster. If they can, we could have something special. Marketing is the answer, and they need to partner to accomplish this, I do not think they can get this message out on their own - or at least quick enough to avoid another dilution...
    28 Sep 2013, 12:38 PM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    "I think you point out AMRNs biggest hurdle however. Can they get the message out that this is not FISH OIL."

     

    Great point - one I had to make to my own doctor last week, as a matter of fact - some bloodwork showed an issue related to fat intake/digestion, and he wondered whether V might be the culprit - I had to point out to him that V is pure EPA (icosapent ethyl), an omega-3 fatty acid - it is NOT a fat. Many OTC fish oils, OTOH, do contain plenty of fats, thus his confusion.

     

    I'm his guinea pig for using V for inflammatory conditions, so he's following my progress closely - excellent results so far, BTW, Lp-PLA2 has almost disappeared entirely, down to 15 from 400+ in just 3 months, but he's been way too busy to delve into the science behind it so far. Perhaps that will change after he's satisfied V is helping me with no side effects and he begins considering prescribing it for his other patients - he's been way ahead of the curve on the "chronic systemic inflammation is the source of all evil" bandwagon, but has been attacking it from a different angle, primarily dietary restrictions, i.e. treating metabolic syndrome.
    30 Sep 2013, 03:05 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    It is not "my" premise. The research and documentation is out there in peer reviewed medical journals and other venues. Disagreement with "the premise" would indicate that you have already done the appropriate research and yet you are still equating Vascepa with fish oil etc, which would indicate that you have not. I guess it was worth a try, lol. I suppose readership through controversy is more lucrative.

     

    If it bleeds it leads.
    26 Sep 2013, 04:50 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    He won't do the article, because he will be forced to backtrack and side with the truth, which he had to do previously when he was forced to admit that Vascepa was the best drug in it's class.
    26 Sep 2013, 07:00 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    small band of amrn diehards..hahah,, and ive never heard any say they hate you.. they just disagree with your written words... big difference as.. you should know..
    26 Sep 2013, 06:13 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    you should see my inbox
    26 Sep 2013, 07:35 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    The Senate voted Friday to approve legislation to keep the government open until Nov. 15. The vote for final passage was 54 to 44.

     

    No adcom delay, period.
    27 Sep 2013, 06:01 PM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    In case you don't already know, (tongue in cheek) all it takes to get a full inbox is to make a comment that is designed to make a group react. The fact that you actually seem to believe what you are saying makes it all the more humorous...
    28 Sep 2013, 09:16 AM Reply Like
  • Deep.Blue
    , contributor
    Comments (131) | Send Message
     
    Have we ever seen the Adcom make a decision based on cost - or is it purely safety/efficacy that they consider? If cost is not part of the equation at all, and with placebo safety, this is a huge no brainer. SPA is cherry on top that almost isnt even needed....
    26 Sep 2013, 07:00 PM Reply Like
  • Jolk
    , contributor
    Comments (219) | Send Message
     
    This is an image comparing the aortic fatty lesions (through Sudan IV staining) in a mouse fed a "Western diet" without EPA supplement and with EPA supplement:

     

    http://bit.ly/18sEMPN

     

    Read more here:
    http://bit.ly/191RoKx
    26 Sep 2013, 07:40 PM Reply Like
  • Samuel-
    , contributor
    Comments (103) | Send Message
     
    Make sure you have enough popcorn for this adcomm event
    fish oil flavored
    26 Sep 2013, 07:57 PM Reply Like
  • kokoszka4
    , contributor
    Comments (3) | Send Message
     
    i don't get how AF can say Vascepas launch has been a huge disappointment, slow maybe, but prescriptions inc everyday, as do the number of ins companys giving V tier 2. we are on par with lovasa when they had zero competition and way more sales reps.
    26 Sep 2013, 09:36 PM Reply Like
  • PhillyBob11
    , contributor
    Comments (2) | Send Message
     
    If i recall, didn't AF also post something like if AMRN doesn't get NCE, they won't get NME? Or, am I mistaken?
    27 Sep 2013, 09:05 AM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    Ha, I forgot about that. Yes, he did. Burn.
    27 Sep 2013, 10:41 AM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Seriously I don't understand why people even entertain AF? He never writes about facts or evidence based info, so when you bash or argue with someone like AF that has NO real basis for what he writes it is useless..

     

    It's exactly why people on Reality TV make so much money.. If no one watched or entertained the nonsense they do, then all those shows would be canceled..

     

    So just ignore it all... :)))))
    27 Sep 2013, 03:43 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    thanks mr pearson, im just a silly retail investor.. who has read so much on armn.. with the spa. and how epa, (that fish oil HAHA) WILL TRANSFORM those that are ill.. not only in the usa but internationally.. I only laugh in jest.. im so sad that most don't get it..
    27 Sep 2013, 08:35 PM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    Frustrating that on 9/27 we are still below $7 per shsrel I thought by now the pre adcom run up wold have begun, thoughts?
    27 Sep 2013, 05:42 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » double digits soon, scripts out and hit over 6K for first time. shorts in serious trouble if they didn't cover when we slid on the financing...
    27 Sep 2013, 06:00 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    Shorts might still be in control until AMRN is sold in 2016
    27 Sep 2013, 07:55 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    2016.. please give us some insight on your belief that the year of 2016 is the year of the BO, and why would bp wait that long to pay a premium price,, so what is your insight
    27 Sep 2013, 09:16 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Good post on YMB- care to comment why the total market seems to be shrinking....

     

    "Good anolgy. Where is the delta going? Does it mean that those folks not renewing Lovaza and or Niaspan are going to the OTC? Is their Doctor aware of Vascepa? If not, why not? If so, why not prescribe? Can all these Physicians be that unaware?

     

    I wouldn't want to rely on this data, is it truly accurate? Of course things being relative and the data is coming from the same website. The big question is, where are these 4500 folks turning to? I don't have an answer. All I know is Vascepa although slowly rising, I'll take 3 - 4% increase per week. Between now and EOY (12 weeks?) that number should rise 36 - 50% from where it is now. So worst case @ 36% we have approx. 8200 scripts per week, @ 50% = 9030 by EOY 2013. As for Q1 2014 projections should be much higher especially with Anchor indication. I don't like predicting, I'll wait for the DVD."
    27 Sep 2013, 09:32 PM Reply Like
  • amrnBagHolder
    , contributor
    Comments (73) | Send Message
     
    Very easy answer.... Doctors are NOT AWARE or are aware and won't prescribe because not on TIER 2 yet. It is so obvious that this is a good drug, but AMRNs 275 sales reps are just not cutting it. Our small gains weekly are nice, but by the time this really gets going, there will be more competition or challenges to the patents. We need a partner or get BO quickly. A Big Pharm has the power to get this marketed correctly!!! Now, it would be prudent to wait until after Dec 20th, to strike a deal. If we have anchor or not, Big Pharm should be able to have an idea what AMRN is worth. Shortly thereafter (Dec 20th), JZ is doing the public and its investors a disservice by holding onto this company for their own sake - and salaries.....
    28 Sep 2013, 12:50 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Great news....
    Saw this on ihub!!!!

     

    "Just found Aetna's 2014 formulary changes - V will be T2, no pre-auth, preferred drug status. Yay! Should see a big bump in sales Jan 2014 - I expect most other insurance companies to also have it T2 next year, plus the ANCHOR"
    28 Sep 2013, 03:43 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    This happened on July 1st, 2013. Old news.
    29 Sep 2013, 11:10 AM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    Not old news - I wrote the quoted bit - V will not be T2 on Aetna for Medicare policies until Jan 2014 - July is when they added it to some commercial plans. Currently V is not on their Medicare formulary at any tier and requires pre-auth just to get it at T4 co-pay rates.
    30 Sep 2013, 03:09 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    What's your take on this YMB post, esp. #3

     

    "There are 5 things the market will start to "get" shortly. FUD is over.

     

    #1) Almost all insurance discrimination will end Feb 1, 2014, the obligatory year. Even in MARINE that means scripts will be sharply higher. The fact V has grown faster than recent blockbusters with 275 sales reps and nothing but disadvantages in MARINE versus anything else is amazing. It's totally based on the V profile and convincing doctors to at least try the stuff. It also means doc's are already seeing amazing results, otherwise the numbers would have stopped going up.

     

    #2) The major JELS sub-group divergences occurred at 1 1/2 years, (about 35% improvement in adverse heart events), which is where the earliest REDUCE-IT members are now, (about 500 of them). REDUCE-IT is based on people who will benefit more than the JELIS sub-group at more than double the dose, shown to be twice as effective.

     

    #3) The recent release by AMRN saying they will have patients at a baseline of 200 mg/DL of triglycerides at trial END means the trial is about to be halted. Beginning trial participants are only slightly over that figure so an end 200 baseline is next to impossible unless an influx of new patients, (such as 4000 to 6000), increases the overall number to 200, (which it will fall below quickly). NOTE: The 200 end baseline notification in the AMRN PR was the first time AMRN indicated this was in play. There was no reason to mention this otherwise.

     

    #4) AMRN doesn't issue bold PR's stating things like the FDA is bound to the SPA agreement unless there are safety issues. The only thing that gets a PR like that out to the public is clearance from the FDA itself. It was a warning, not a PR.

     

    #5) The key is looking at the data today. For those that think the FDA may want outcome results, well, if so, they already have them. Why not look at data right in front of them? The recent HD study and numerous other articles showing conclusive help to arterial plaques demands it."
    28 Sep 2013, 06:49 PM Reply Like
  • sts66
    , contributor
    Comments (1131) | Send Message
     
    "What's your take on this YMB post, esp. #3

     

    #3) The recent release by AMRN saying they will have patients at a baseline of 200 mg/DL of triglycerides at trial END means the trial is about to be halted. Beginning trial participants are only slightly over that figure so an end 200 baseline is next to impossible unless an influx of new patients, (such as 4000 to 6000), increases the overall number to 200, (which it will fall below quickly). NOTE: The 200 end baseline notification in the AMRN PR was the first time AMRN indicated this was in play. There was no reason to mention this otherwise. "

     

    False interpretation, and wording that confused me at first too, until someone on IHUB pointed out that it actually means that AMRN is taking steps to ensure that the remaining 2000 patients to be enrolled have *baseline* TGs > 200 - baseline meaning prior to them entering the trial. It has nothing to do with the ending TG level, and if you think about it the reason is clear - if TGs are >200 at the end of the trial V will clearly have failed to work!

     

    I suspect that some clinics were admitting borderline cases to the trial, or ones that did not have TGs > 200 but would obtain needed health benefits from taking V, but they can't obtain it in foreign countries - i.e. sneaking unqualified patients in for other reasons. AMRN is recruiting strongly in Eastern Bloc countries in Europe, where alcoholism, liver/TG, and pancreas issues are rampant in some areas - EPA can treat pancreatitis.
    30 Sep 2013, 03:20 PM Reply Like
  • Teebonekrusher
    , contributor
    Comments (4) | Send Message
     
    I see where AF was taking another swipe at AMRN today. He is a horrible person who is rotten to the very core. Oh but wait, when his brother in law gets brain cancer he plays the humanitarian and begs his followers to donate money for his brother in law. Sugar wouldn't melt in his mouth when he is asking for handouts. I wonder if a drug that would be made available to treat his brother in law was being reviewed by an adcom if he would be singing a different tune. Well Vascepa could be made available to treat many people and all he does is root against it because management won't return his phone calls and his ego is bruised. Perhaps we should all be rooting against his brother in law. If Af was a nicer person I may have even made a donation, I did not.
    29 Sep 2013, 12:12 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    you're a dufus.

     

    1. My brother in law doesn't have brain cancer. I was doing a favor for a friend.

     

    2. brain cancer if life threatening. Having elevated triglycerides -- not so much.

     

    3. Vascepa is not a life-saving drug.

     

    4. did i mention you're a dufus?
    29 Sep 2013, 03:16 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    eventhough i agree his predictions are right I have to say this guy gets a heart attack soon. only a selfish ruthless person would wish for failure of a drug that will save thousands if not millions of people. this is proven. those who argue that it does have any benefits does not have any cardiovascular problems like Adam F.
    30 Sep 2013, 09:52 AM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    Doing a favor for a friend? Isn't that what so many readers claim is the problem with you?
    30 Sep 2013, 10:02 AM Reply Like
  • see punjabi
    , contributor
    Comments (354) | Send Message
     
    He even forgot his constant attacks on arna for negative vote on adcom and then no on fda approval. I remember, to prove his points, he even picked several statements from company's 10Q statements, modified them, manipulated and presented in his weekly article saying the company is expecting a no on adcom and fda vote. His attacks on acad, and dndn before approval when it was trading below $3.
    29 Sep 2013, 12:14 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    By coincidence he happens to attack highly shorted stocks. lol
    29 Sep 2013, 03:04 PM Reply Like
  • adamfeuerstein
    , contributor
    Comments (305) | Send Message
     
    I also skin kittens alive and throw old ladies down stairs.
    29 Sep 2013, 03:16 PM Reply Like
  • louieblouie
    , contributor
    Comments (23) | Send Message
     
    i believe it!
    29 Sep 2013, 03:56 PM Reply Like
  • pwt750
    , contributor
    Comments (67) | Send Message
     
    I have seen a couple 100,000 shares or so dumped on the market mere minutes before one of your one sided hit pieces land on thestreet enough times to believe practically anything. But as I don't care for cats, carry on your extracurriculars.
    30 Sep 2013, 12:05 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    AND YOU probably,, bash stocks as well... poor pitiful person..
    1 Oct 2013, 06:53 PM Reply Like
  • bullscan
    , contributor
    Comments (23) | Send Message
     
    yeah i saw u other day pushing over a old lady at a mall.
    2 Oct 2013, 06:31 PM Reply Like
  • joe gerant
    , contributor
    Comments (26) | Send Message
     
    And Adam thought the Adcom meeting was going to be delayed? Riiiight.
    3 Oct 2013, 09:17 AM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Steve your thoughts on today and what happened? Alot of comments suggesting that the FDA will ask for more reduce it info before approving anchor. Are u still thinking we get the okay in December
    11 Oct 2013, 04:20 PM Reply Like
  • xtradersdotnet
    , contributor
    Comments (23) | Send Message
     
    Steve its been over a year now and still nothing positive has come out, fact is fact and if you had invested in this a year ago you would be down BIG time. How can you still remain so bullish when the stock has gone from 16 to 5, do you really think that its still going to 20 or even 35? I hate to say it but it appears one has made a major misjudgment and the end result is longs losing lots of $..

     

    I am now glad i had hardly any $$ to put in this, i have followed you for over a year now and only got burned, I would still love to follow you but guess what NO MORE $$, so i think its time to hang it up and for anyone noob do your own DD and make your own decision.
    11 Oct 2013, 04:31 PM Reply Like
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