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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
  • Ahead Of The Curve: Amarin To Release Better Than Expected Combo/Statin Data 37 comments
    Jun 17, 2013 3:28 PM | about stocks: AMRN

    Combo data should be released as next major catalyst for Amarin (NASDAQ:AMRN). I am expecting better than expected endpoint results.

    Stocks: AMRN
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Comments (38)
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  • Ladavis23
    , contributor
    Comments (13) | Send Message
     
    Steve,
    Do you think that going from "good" combo/stain data to "great" combo statin data alone will be enough to actually move the current pps higher in this enviroment for the company? Every catalyst since late last year has been met with pressure and more pressure. Aside from being attached with a partnership or another type of deal, what will make this "cataylst" different from the others? Thx
    17 Jun 2013, 04:05 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Yes, and my opinion is the only rational way to explain trading now is that the funds are not back in yet, meaning they believe there is more time before next major leg up.
    17 Jun 2013, 04:12 PM Reply Like
  • amrnBagHolder
    , contributor
    Comments (73) | Send Message
     
    There is not question there is more time. The question is if there will be another "leg up". From my account name, you can see I am starting to doubt.... Very Very frustrating. Best drug for your health - worst drug for your portfolio!!! Total lack of faith on WS. With these latest script numbers we should be tracking higher - instead we are down on a good day in the market. Is AMRN not sharing something? It can't be explained by the silly nonsense articles these shorts keep coming up with, can it?
    17 Jun 2013, 05:10 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Institutions are probably not gonna fall for the same jive this time around. Hedgies will probably play the runup to an extent. However, Joe Z. has burned Wall St twice now. Once in 2011 with the "we've got more offers than employees" and again in 2012 with " the next 60 -90 days is going to be exciting". I suspect that if management can't articulate a concrete commercialization plan for ANCHOR in the very near term, Wall St will adopt a "show me" approach. Everyone knows that something has to happen, they just don't know what. Based on the past, prognostication has been bad for portfolios.
    17 Jun 2013, 08:15 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    Well stated pirate, and true. I personally think if Joe was fired and replaced that we get a deal done by the end of the year. There is a real possibility this goes to five soon. If joe let go which won't happen as think share price jumps.
    22 Jun 2013, 03:02 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Steve - I know this is a bioavailability /pharmacokinetics study and with acceptable results could possibly skip further testing.

     

    What are the endpoints exactly?
    17 Jun 2013, 07:51 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Known as AMR102, the study is to determine the bioavailability of the EPA in AMR-101 (Vascepa) and statin components when taken as one fixed dose, relative to the statin alone. With safe tolerability and effective uptake, this will tp the hat to pharma suiotrs that have statins, and let them know AMR-102 would be complimentary. While it could skip phases testing for Amarin, it bascially would provide a pharma company with statins a new pipeline drug without hundreds of millions of dollars of dev. costs.

     

    "Statin bioavailability from both the fixed-dose and concomitant regimens will also be compared with that from the reference statin taken alone in healthy subjects."

     

    "Additionally, pharmacokinetic data from this study will be examined to explore relationships between in vitro dissolution data and in vivo pharmacokinetic data. The study is designed as a randomized, open-label, multiple dose, parallel-group study in 48 healthy subjects conducted at a single site in the United States."
    17 Jun 2013, 10:59 PM Reply Like
  • see punjabi
    , contributor
    Comments (351) | Send Message
     
    Steve,
    When do we expect data to be release, in june or july?
    17 Jun 2013, 11:10 PM Reply Like
  • 5967241
    , contributor
    Comments (88) | Send Message
     
    When ?
    17 Jun 2013, 11:24 PM Reply Like
  • see punjabi
    , contributor
    Comments (351) | Send Message
     
    Steve,
    Why delay in combo result, it should have been released by this point?
    17 Jun 2013, 11:25 PM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    there is another Anchor Patent NOA, due out anytime, not sure if you consider that a cataylst
    17 Jun 2013, 11:25 PM Reply Like
  • Mick J
    , contributor
    Comments (9) | Send Message
     
    This week?
    17 Jun 2013, 11:25 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    This will not be a "catalyst." Wall Street already expects good results. Great results won't change a thing. The only thing that might move this stock is Anchor approval. It's obvious based on recent developments that AMRN will be unable to sell or partner until then.
    17 Jun 2013, 11:25 PM Reply Like
  • see punjabi
    , contributor
    Comments (351) | Send Message
     
    Agree amrn bag holder,
    This is the best drug with best safety profile and look where the stock price is trading now. I guess, management's initial decisions are responsible for this to some extent. They started making big noise regarding buyout way early when they should have launched their drug right after approval with focus on hiring sales rep. They should have made planning way before approval instead of launching the drug 6 months after fda approval. This is ridiculous where the stock is trading now.
    17 Jun 2013, 11:27 PM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    It blows my mind that shareholders are calling for Joes head and adding seats to the board. I guess with little to no institutional support we are hanging. Seven people I. Te board and one is Joe, groupthink possibly? Why not bring n at least two other experienced board members, perhaps a former CEO of big pharma? It seems the company needs guidance does it not?
    22 Jun 2013, 03:05 AM Reply Like
  • moeschempf
    , contributor
    Comments (30) | Send Message
     
    Thanks for the article, Steve. You've probably seen this already, but I've attached a link to the PriMed presentation, "Tackling the Toughest Issues and Cases of Hypertriglyceridemia" co-sponsored by Amarin. Dr. Brinton is one of the presenters: http://bit.ly/14kVCMD
    20 Jun 2013, 11:13 AM Reply Like
  • tobingj
    , contributor
    Comments (100) | Send Message
     
    @Moes the link appears to be broken.
    21 Jun 2013, 04:25 AM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    Hey Steve, are the results today what we were looking for in reference to combo data or is it something else that you were waiting to be released?
    21 Jun 2013, 10:56 AM Reply Like
  • moeschempf
    , contributor
    Comments (30) | Send Message
     
    Amarin Announces Positive Results of Phase 1 Clinical Trial Measuring the Bioavailability of a Fixed-Dose Combination of Vascepa(R) and a Statin Compared to Concomitant Administration
    New Patent Allowances From MARINE and ANCHOR Trials for Fixed-Dose Combination http://on.mktw.net/13X...
    21 Jun 2013, 11:12 AM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    I hate to say it Steve but the short own this stock and I mean own it. The do whatever they want with his stock. I have a feeling we are so screwed.
    21 Jun 2013, 11:15 AM Reply Like
  • exp456
    , contributor
    Comments (31) | Send Message
     
    This is dead money until second week of Oct. Nothing can prop this up--SR articles or reiteration of Aegis target prices
    21 Jun 2013, 01:36 PM Reply Like
  • see punjabi
    , contributor
    Comments (351) | Send Message
     
    Steve,
    How come no information regarding the data obtained was released.
    21 Jun 2013, 03:15 PM Reply Like
  • 5967241
    , contributor
    Comments (88) | Send Message
     
    Better than expected results ? Wow the price action tells the story.
    21 Jun 2013, 03:34 PM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    I agree the giving of no result sounds really fishy. I am a hardcore bull but this is the first time since I owned this stock that I feel like we are screwed. The shorts run this stock.
    21 Jun 2013, 09:40 PM Reply Like
  • amrnBagHolder
    , contributor
    Comments (73) | Send Message
     
    Yes... i agree seems like ws knows something we don't. I believed todays news would at minimum get us back in the 8s. A drop in pps was not even a thought. Now I think AF Might be right. The FDA must of had enough of fish oil products. Even though we have the one that actually works. We were apparently too late, Big pharm doesnt seem interested either....
    22 Jun 2013, 12:03 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    The FDA is not "sick" of fish oils. As a matter of fact Amarin has an excellent relationship with the FDA having put together 3 major trials all under special protocol assessment (SPA).Wall st doesn't "know" anything sinister. The combo trial was overhyped. It was a very small (n=48) phase 1 trial which merely proved a concept...i.e. that a combo drug is viable. Way too much value was put on the results here and in other venues.

     

    In absense of a real PPS mover, everyone, myself included is getting restless and looking for something to move the share price. Compounding the problem are the plethora of negative articles being puked out almost daily by anyone with a keyboard. The fact is that there is a real lack of education and widespread belief of what pure EPA can do.

     

    The next true catalyst will be the Adcom. It is there that Amarin has a chance to shine and I welcome that. During the panel there will be a chance to discuss the merits of the JELIS study ( you'd be surprised how many Drs. haven't heard of it). In addition, there have been numerous studies that highlight the absorbtion of EPA into atherogenic plaques above and beyond what DHA can do AND that this results in a reduction of the area and volume of the plaque as well as stabilization. Finally, Vascepa has been proven to reduce important inflammatory biomarkers implicated in heart disease. This sort of exposure is absolutely priceless and the Adcom will shine a light on all of the positives in a highly anticipated and well covered forum. Last but not least, the ANCHOR trial results will be discussed in the open and the true differentiation between Vascepa and Lovaza and all other "fish oils" will be exposed like never before.....once and for all.

     

    On the business side, I don't believe anyone is going to fork over $35.00/share ( 6 billion dollars) for Amarin until there is either results from REDUCE-IT ( the paradox here is that positive results from REDUCE-IT will likely mean twice that price tag) OR Amarin and their crew blows the Adcom out of the water. It might be possible to see a deal of $20 - $23 a share with significant CVRs based on future sales and REDUCE-IT trial results.

     

    In the meantime, this is a poker game. Scripts are growing and IF we continue, we could see enough monthly scripts at year end to translate into BB status in 2014. That is definitely within reach. In the absense of a buyout, the big question will be HOW Amarin markets Vascepa in 2014. The sooner they answer that question, the better off we shareholders will be. I pray for some clarity by the August CC. Mgt however, has to balance alot of variables to come up with an answer. Some of those variables are unknown at this time. So we wait.....................
    22 Jun 2013, 08:08 AM Reply Like
  • rydad21
    , contributor
    Comments (34) | Send Message
     
    Very well written concise post. If they ever print a book called "Amarin for Dummies", this post would be the prologue. Thanks..
    22 Jun 2013, 03:43 PM Reply Like
  • tobingj
    , contributor
    Comments (100) | Send Message
     
    With AMRN it should always be a thought.... In the old days there was huge speculation that it was manipulated but it just acts contrary to expected reaction. I think it is off the radar and only big big news shifts it.
    24 Jun 2013, 04:30 AM Reply Like
  • Ladavis23
    , contributor
    Comments (13) | Send Message
     
    Steve,

     

    Were these the better than expected results you were expecting?
    22 Jun 2013, 12:26 PM Reply Like
  • Bioplayer1
    , contributor
    Comment (1) | Send Message
     
    Steve,

     

    With the Phase I endpoints of AMR102 met, we now know the combo to be Crestor. I think we also have a recent patent receiving NOA. Could you clarify how Amarin intents to utilize this product given AZN's recent purchase of Epanova? Obviously AZN has the marketing muscle to defend Crestor when it goes generic in 2016.
    23 Jun 2013, 06:13 PM Reply Like
  • Ladavis23
    , contributor
    Comments (13) | Send Message
     
    Steve,

     

    Question....what on earth is AMRN thinking?? They have been sitting on combo data for MONTHS. It was data that they had complete control to the how, and when they could release. So what do they do? They release a weak pr with no hard data, on a Friday, in the summer, hovering at fresh 52 week lows, hours after the market had it's worst day this year. I mean, are you kidding me??
    23 Jun 2013, 09:12 PM Reply Like
  • tobingj
    , contributor
    Comments (100) | Send Message
     
    Almost as if they want to keep the price low?? Huh?
    Look back over the last five years and look at their release times.
    Even poor managers would have hit it right once in that time.
    25 Jun 2013, 05:15 AM Reply Like
  • see punjabi
    , contributor
    Comments (351) | Send Message
     
    Steve,
    Excluding the fact that amrn is a blockbuster drug, it's management had failed miserably. We need management like Qcor company, very disciplined management. This management lacks skills in terms of when and how to issue any PR related to the drug. They don't know when to open their mouth and how to express themselves. Certain unapproved drugs with no fda approval and no sales are trending much higher compared to amrn. I hope we don't see any new 52 week low. This is what happened to DNDN as their management made similar mistakes in overshooting sales during their first quarter and look where dndn is trading from a 52 week high of nearly 60 dollar to $4. No matter how good the product is still execution needs to be perfect in order to sell that product. This management needs to be replaced.
    23 Jun 2013, 10:58 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Punjabi - If management had failed miserably, how could Vascepa be a blockbuster drug? Actually mgt has done a very good job at execution but a less than stellar job at communication. The biggest screw ups were Joe Zs when he led investors to believe a buyout was imminent.....on two different occasions.
    Comparing AMRN to DNDN is ludicrous. DNDNs provenge was mispriced, had coverage problems and had a very minimal overall value/effect for the price and coverage problems all in the face of increasing competition. AMRN suffers from no such missteps.
    My bitch about AMRNs mgt is the last minute communication about important strategic decisions which have a profound impact on the PPS and the lack of clarity on the path forward. This has led to way too much speculation. This combined with the FDAs lack of an exclusivity determination (for a year now) has hurt everyone.
    24 Jun 2013, 08:05 AM Reply Like
  • exp456
    , contributor
    Comments (31) | Send Message
     
    Even Steve has left the Bldg! I think we're on our own now LOL
    24 Jun 2013, 12:01 PM Reply Like
  • ringbellplease
    , contributor
    Comments (23) | Send Message
     
    Even Steve has stopped responding! He must have come to the realization that pumping this stock is not going to help increase the stock price.

     

    Can't wait for his next prediction.
    24 Jun 2013, 01:52 PM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    There is obviously something going on here behind the scenes that we don't know. Retail investors are always last to know. Today's developments confirm what I was hoping was not true. See you in the 4s.
    24 Jun 2013, 07:25 PM Reply Like
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