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  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    I will see what is the best way for me to PM it to your SA inbox. It's not listed as a link, but the entire doc is long. There is also a part in the sNDA that shows the agreement the pharmacology/toxicology team came to with AMRN allowing and accepting a separate non-clinical study to "bridge the gap" between Epadel and Vascepa so AMRN could use the JELIS study as proven CVD data.

    I have to look for it but I also have info that came out in the past that shows when the FDA started to allow AMRN reps to use Jelis Study data when speaking to doctors regarding Vascepa.

    Yet the adcom panel disregards the Jelis Study as any relevant data. So the FDA Panel discounts the ONLY study with a EXACT match in drug Compound, but then the FDA uses NON-TG drug studies of separate drug compounds as their so called "scientific evidence", to rescind SPA. HAHA.... Really...

    It even states on the FDA's own website, "Triglycerides are another form of fat in your blood that can raise your risk for heart disease."

    The FDA has recently stated "they don't believe lowering TG levels, helps lower risk of CVD".

    So help me understand, "If High TG levels can RAISE your RISK for HD", then how can "LOWERING your TG levels NOT help in Lowering your Risk of HD"...

    I'm telling you man, the more you dig and see all the facts, the more the focus shifts further away from AMRN.
    I know many out there wanna try and bash, but when you look around everywhere recently, there isn't 1 person that can back up any claim against AMRN with a piece of info or document that shows AMRN is at fault here. People seem to think that a stock price is validation for the non sense they keep saying, but the truth is that when you look at all the facts, the stock price only proves that something shady is going on.
    For a while now I have spent a lot of time providing a lot of info and facts that many didn't know, and yet every basher that would come back at me NEVER provided a piece of information or truth to back up there own claim.
    I'm not saying shareholders shouldn't be pizzed, because they have every right to be. However, they are looking at the wrong things.

    I'll get you what I can, but i'll keep it private.
    Nov 5, 2013. 03:56 PM | 2 Likes Like |Link to Comment
  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    So in conclusion the Anchor Spa trial was to have Vascepa approved to lower TG levels in patients 200-499 "DESPITE STATIN" Therapy.

    Although a portion of the Anchor TG patients do take Statins there is stilla large # of patients in this population that DO NOT take Statins and deserve to have a treatment for their TG levels.

    The most effective and safest drug for those patients as PROVEN by it's SPA anchor data is VASCEPA..

    So if the FDA really wants to change things for the entire Patient population including Statin patients under anchor, then the PROPER thing to do, since AMRN met all SPA requirements as asked is to at least ISSUE an APPROVAL for the Anchor patients to treat TG levels "despite a statin" until RI is done, then expand the label if the RI data shows the proper results..

    That is the FDA's job. Approve the safe and effective drug to treat the primary issue (lowering TG).
    Lovaza gets 40% of it's sales from off labeling to Anchor patients "that DO NOT" take a Statin.
    So therefore if the FDA delays Vascepa on even a partial label, they are allowing a drug (lovaza) with severe side effects (raising LDL levels) to continue to be marketed ahead of a SAFER DRUG like VASCEPA..

    I thought the FDA's #1 concern was supposed to be SAFETY of the patient...
    Nov 5, 2013. 02:06 PM | 3 Likes Like |Link to Comment
  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    I agree, Ganj1948, your right on point with your post. Something bigger here isn't adding up. You seem to see the whole story here, but it seems many others are blinded by the smaoke and have been for a long time.

    I feel many are confusing the differences between studies, markets and drugs.
    For example... The Anchor Population is a TG patient population between 200-499. Not a Cholesterol or Lipid Patient population. ONLY a High TG Patient population between 200-499. (36 mill people)
    The borderline TG Patient population is 150-199. That was where the Reduce-it study was focusing on. (another 30 mill+ people)

    It has clearly stated this on (page 7) of AMRN most recent Corp Presentation.
    PLEASE EVERYONE GO LOOK.. There it is all 3 Patient populations in black and white for the last 3 years..
    Marine TG 500+
    Anchor 200-499
    Reduce-it 150-199
    US adult Population based on "TRIGLYCERIDES".... Not Cholesterol..

    Now starting from the basicis the ONLY reason why for the last 70+ years that patients with TG Levels from 150-499 have even been treat with Statins, Fibrates, Niacin etc, is because prior to Vascepa's ANCHOR data, NO OTHER "TG Lowering" drug has been approved or has been able to be combined with a Statin bc of it's side effects...

    So therefore NO MATTER how many different studies the FDA looks at that are using Chol Drugs like statins, Fibrates, Niancin etc, they will all not show a benefit relating to TG levels and CVD because they are NOT directly related to Treating TG levels.

    This is WHY there were 3 different studies designed to begin with (M, A, and RI).. Marine Trial was for ONLY TG 500+ patients.
    ANCHOR was designed for TG levels 200-499 "despite a Statin" and 25% of the Anchor Spa was designed to show that Vascepa bc of its safety could be Combined with any Statin.... "That's all.. Just showing they could be combined together, bc all other drugs in past FAILED bc of side effects (example Lovaza).
    Go back and read the full ANCHOR results and it shows that this data well exceeded the endpoints both Primary and Secondary under the SPA set by FDA. It also showed that out of all the Statins combined with Vascepa "Lipitor" worked the best...
    This is WHY many people speculated in the past that Pfizer was gonna buy AMRN.. Why i don't know..

    Then the REDUCE IT study is designed to then take Vascepa and a Statin and combine the 2 for Both patient populations of TG levels from 150-199 to 200-499 and RI is designed to show if COMBINING the 2 drugs will show a decrease in Heart attack and stroke related CVD's.

    So AMRN ran the Anchor trial the way the FDA specifically designed the SPA in relation to the Anchor TG martket population.
    Now at the 11th hour before adcom, the FDA went OUTSIDE of the SPA agreement and the Anchor trial SPA design and "CHANGED THE RULES"!!!
    This is the truth and it has nothing to do with being long or short AMRN. This is also backed up by the fact that EVERYTHING during adcom was based around Reduce-it (a study not even done yet) and the FDA has now broken the SPA using "OTHER OUT COME studies, with NON-TG treatment drugs (they where cholesterol drugs) and a different patient population for most of the study data (TG 150-199).

    How do we know this is a fact because it has also been staed that Vascepa in relation to ANCHOR was going to be a "FIRST IN CLASS" drug... WHY? Because NO other TG drug has been approved for the Anchor population.
    This can also be proven and backed up with any Doctor or Cardiologist that will tell you for 70+ years the ONLY time your TG levels where addressed for treatment 1st was when they were over 500+ mg. This is because the ONLY drugs approved for TG levels were only approved for 500+mg patient population (marine).
    Any time your TG levels fell between 200-499 or 150-199 the doctors would treat your Cholesterol or other Lipid profiles using Statins, Fibrates, Niacin etc, due to the fact that there were NO approved TG drugs for those patient populations.

    Sorry for making this so long and detailed but for a long time 95% of retail has just NOT fully understood the TG Patient Space and how it all broke down into the separate Trails. Between this and the lack of DD that retail does, clearly gave WS a open forum to make you see and believe what they wanted.
    Now today while we see BP's like AZN pay $440 mill for a NON Approved drug with bad side effects and then we see WS giving $100-$300 mill valuations to Bio's with NO approved drug and trials in Phase 1, WE ALL NEED TO ASK OURSELVES....
    How is AMRN, with $230 mill in cash, 30 Patents, Tier 2 Insr, $ top suppliers with growing script #'s week/week and most important AN FDA APPROVED DRUG, valued at $260 mill?????
    There is something VERY wrong going on here However, it isn't AMRN and it's not Vascepa.
    The more REAL HARD DD you do based upon the facts and the entire space, the more you will see exactly what I have brought to light...

    If anyone can produce a link, a document, a letter, an 8k or report that shows anything different prior to the briefing doc's for adcom, I would love to see it. Not SA, Motley fool, AF, MB's or someones opinion, I would like to see just 1 document that shows AMRN didn't meet a certain requirement under Anchor SPA or was notified in writing (under SPA, sNDA, 74 day letter etc) by the FDA that going into adcom these issues from other outcome studies were a topic..
    I would also like someone to show me why all 3 Outcome studies where available to the FDA the entire time, but were never brought up as a concern prior to adcom by the FDA?

    Let me save you all some time... You won't find them!! This is the entire picture and although many may be unhappy about some of JZ decisions not to sell or more PR, it has nothing to do with why AMRN met ALL requirements under the SPA and the FDA changed the rules at the last minute.. I just don't know why this hasn't been brought more to light in any report, article or Lawfirm..
    I guess it's easier to blame amarin then it is to look into the real story.. LOL
    Nov 5, 2013. 01:50 PM | 5 Likes Like |Link to Comment
  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    The basis of this lawsuit "The lawsuit alleges that Amarin's management misrepresented the prospects of the ANCHOR indication and that they failed to disclose that the FDA had communicated to them the lack of data demonstrating a link between the reduction of triglycerides and a significant reduction in cardiovascular risk prior to the ADCOM panel meeting."

    I think that about says it all people.. AMRN's management misrepresented???? How about the FDA is the one that Misrepresented, NOT Amarin!!!

    Over 2 years 3 MAJOR Legal documents from the FDA to AMRN, the over SPA agreement (designed by the FDA), The filing and "acceptance" of the sNDA for ANCHOR and the 74 Day Letter. All of these came back CLEAN on all points and NEVER stated to Amarin any indication of what the FDA brought up at ADCOM.
    I have also read in detail the entire accepted sNDA for ANCHOR that the FDA sent back to AMRN and in addition to the sNDA NEVER stating any of the above concerns, the sNDA also stated that the Pharmacology/toxicology team approved and accepted a separate non-clinical study done by AMRN to "bridge the gap" between Vascepa and Epadel to allow the JELIS study to be used as evidence that Lowering TG Levels in patients 200-499 mg/dl does reduce risk of Heart attack and Stroke.

    The evidence is RIGHT there in Black and WHITE my friends, you just have to do some real DD and stop reading what the media wants you to read. This was a sham job by the FDA and I don't know who is behind it, but I can tell you that this WAS NOT Amarin's doing.

    Yes I will agree that maybe JZ and the team might have been a little naive towards their relationship with the FDA and thinking that simply because they had a SPA and all the legal documents came back clean that it was a slam dunk, so to say. But that is all if anything that Amarin and JZ are guilty of. And 9 out of 10 CEO's would have felt the same way.

    This is why my friends that "prior to AMRN", in the history of the FDA they have never not approved a drug or rescinded a SPA, when the Company had met or exceeded all endpoints in the SPA.

    Now for the first time the FDA rescinds a SPA after all requirements are met/exceeded, along with a clean sNDA and 74 day letter based upon 3 TOTALLY Separate Outcome studies, that used different chemical drug compounds and different Patient populations.

    Then decides to give AMRN notice 2 days before the ADCOM Meeting, when the FDA had access to ALL 3 STUDIES the entire time. 2 Studies where available to the FDA before the SPA was designed and the last study was finished before the sNDA.

    I am still waiting for SOMEONE, ANYONE, to show me a document or a piece of factual information that "says otherwise"....

    All I have seen lately in the media is a bunch of accusations about AMRN and it's management, but not one piece of info to back up any of those accusations.
    Nov 5, 2013. 10:29 AM | 9 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    On another quick topic, AMRN entered ADCOM and got blindsided.

    That ADCOM meeting did not discuss or vote on the topic or Trial that the ADCOM Panel was "SUPPOSED" to be there to discuss and vote.

    This is without question a FACT! So much so that if you go back you will see SEVERAL Panel members state that they were "confused on topic and question, didn't understand what they were supposed to vote on, REQUESTED to at several points Change the Voting question and even ask WHY the rules were being changed for AMRN when AMRN had done everything the FDA had required under SPA!!!

    ADCOM was a miss bc ADCOM wasn't about ANCHOR or Vascepa's efficacy and safety when lower TG levels.

    If the ADCOM Meeting was about discussing and voting whether Vascepa's efficacy and safety show value/benefit when lowering TG Levels in patient 200-499 "DESPITE a Statin Therapy, then ADCOM would have been 1000% a Positive vote across the board.
    That is what the ANCHOR trial was designed for and that is what the ADCOM meeting for ANCHOR should have been about.

    Yet again everyone blames AMRN. How? It is funny however that the FDA NEVER notified AMRN when it came to the design of the SPA, the sNDA, the 74 Day letter, YET at the 11th hour, the FDA did what they wanted anyway.

    Last time I check again the ANCHOR population is a Triglyceride Patient population between 200-499. It's NOT a Cholesterol patient population. The only reason why a portion of the Anchor TG patients even take a Statin to begin with is bc Vascepa is the 1st and ONLY drug in over 70 years to be able to safely and effectively treat them..

    I figured 70 plus years of 1/3 of the US population not having a treatment for Trigs & Chol together was long enough..
    Nov 4, 2013. 02:22 PM | 8 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    How much longer will SA or Yahoo etc continue to let this go on.

    This Blogger and Many others have written blog after blog and continued to mislead without telling the entire story. In the very first paragraph towards the end it states "fact that the FDA had determined that "a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began."

    So let's begin here and move ahead using what has been proven..

    #1 - There is NO scientific evidence in regards to Vascepa.

    #2 - The evidence being used is based on OTHER DRUGS and OTHER Studies, NOT Vascepa.

    #3 - If you do some detailed DD you will find that the studies named by the FDA were different from Vascepa in many aspects (Trial Design, Drug Compound and Especially Patient Population)

    #4 - In the results from Aim High Study it CLEARLY shows that ONLY a "few patients" enrolled had TG levels in 200-499. The majority of the Patients were baseline TG 150-199, WHICH is a TOTAL separate patient population and has NO relation to ANCHOR Trail or Patient population.

    #5 - The FDA on it's own website STATES "Triglycerides are another form of fat in your blood that can raise your risk for Heart Disease"

    #6 - How can the FDA say that High TG levels can Raise your risk of HD, but Lowering TG levels does not lower risk of HD. That makes NO sense at all!

    Look the fact is that the MEDIA in all sorts has attacked AMRN for a long time, when this company hit every milestone along the way and FOLLOWED and ACCOMPLISHED every single requirement the FDA asked of them both in SPA and other wise.
    Everyone is quick to try and blame AMRN, but no one has said a single thing in regards to what the FDA has done.
    NO one has brought up the fact that the FDA over the course of 2+ years in ever LEGAL document to AMRN had NEVER even hinted or attempted to bring any of the "so-called" issues to the table.

    Ok, yes, so maybe many investors are upset that JZ didn't do a deal early on, BUT that's just hindsight now and nothing more then greed by the investor.
    If you really did DD and research on AMRN and the entire situation, the last one you would be blaming is AMRN.

    The truth is that the media has and continues to mislead and it is getting WAY out of control. It's a disgrace to investing and a shame that many retail investors has suffered.

    I will say this though, I have NO clue why this has gone on and NO clue why the FDA has done what they have, BUT what I do know is that there IS NOT 1 single piece if data or science in DIRECT LINK to Vascepa.

    Every single issue has come from someone wanting to blame JZ or using the science of totally different drugs in No relation to Vascepa.
    Last time I checked when ALL other studies for all other drugs don't show a benefit, your supposed to APPROVE the drug that SHOW a positive benefit.
    The one drug that has shown Evidence Based Proven Data that it benefits the patients when it LOWERS TG levels and is SAFER then any other drug is VASCEPA!!
    And Vascepa is the 1st and ONLY drug to show you can Combine it with a Statin without adverse effects or safety issues. And the 1 and ONLY study that has show lowering TG Levels has a significant benefit in reducing Heart attack and Stroke is the JELIS Study.
    The Jelis study is the ONLY study you can compare to Vascepa because Epadel and Vascepa are the same drug (EPA).
    Another FACT that has also been proven prior to the Panel vote.

    Something is up and it has nothing to do with AMRN or Vascepa. And I hope light is shined upon it soon. Both AMRN and it's true shareholders deserve it.
    Nov 4, 2013. 01:58 PM | 11 Likes Like |Link to Comment
  • Did The FDA Just Issue Amarin's Death Blow Again? [View article]
    I couldn't agree with you more. Very well put. You are on point. The 1 point you make the best is that all the constant bashing from all sources when it comes to AMRN is followed by a 100% lack of knowledge on all points (AMRN, Vascepa, The Lipid Space, FDA).

    I have dealt with a lot of backlash from many, but it's never backed up with any hard facts or evidence.

    Good luck ahead.
    Oct 31, 2013. 09:32 AM | 1 Like Like |Link to Comment
  • Did The FDA Just Issue Amarin's Death Blow Again? [View article]
    So funny how people think. Let's look shall we..

    After Oct 16th Panel decision, NO ONE and yes I mean NO ONE in media, blogs, MB's etc believed Vascepa was going to get approval for Anchor on Dec 20th. And NO ONE in media talked about the SPA.

    Now "all of a sudden" the FDA rescinds the SPA and everyone in the media, blogs, MB's now act like the SPA mattered. This is really getting old.

    Who cares about what happens with Anchor. The real truth is Vascepa is an approved drug, selling scripts. It's BETTER then Lovaza and it CAN SELL off-label to both Statina nd non-Statin patients in Anchor market ANYWAY!!

    If lovaza does $1 Bill in sales and 40% of thse sales are off-label in Anchor to non-statin patients, then why would any NOT believe that Vascepa will be a $1 Bill drug at minimum.

    Yes I do agree that JZ and AMRN need to get a plan and use BP and their s/f to truly sell Vascepa at Top potential, but that doesn't mean that Vascepa and AMRN aren't worth MUCH MORE then what the market is valueing the company at now.

    Either way AZN paid $440 mill for a NON Approved drug and GSK paid $1.7 Bill for an inferior drug that still does $1 bill (0nly 50% sales in FDA Approved Marine market).

    So AMRN has a lot a value in the drug and the stock going forward. Whatever happens with ANCHOR and RI are just "additional benefits" if they pan out. But right now AMRN is worth much more then $2.

    The quicker the retail investor STOPS reading blogs and the media and starts looking at the true value at these levels, the quicker AMRN will trade higher and they will make money.

    That simple....
    Oct 30, 2013. 11:27 AM | 9 Likes Like |Link to Comment
  • AMRN: Does The FDA Need To Be Investigated  [View instapost]
    So in your opinion would you say there is a chance that Dec 20th is a "YES" with a controlled label? (Only approval for NON-Statin Patients)

    That is the way I see it possibly! If the FDA was trying to protect their rear so to say, and still stick to the legal side of SPA, and what was outlined in the sNDA and clean 74 Day letter..

    Your thoughts?
    Oct 22, 2013. 09:15 AM | 1 Like Like |Link to Comment
  • New Study: EPA Reduces Cardiovascular Events - Enough For Amarin Approval? [View article]
    Total manipulation going on somewhere.. All of a sudden an EPA study comes out after ADCOM and after months and months of other false comparison studies kept AMRN's price suppressed while Amarin continued to milestone after milestone and have good script growth.. Yet studies that had no chemical comparison to Vascepa found a way to surface and knock AMRN back...
    Now out of the blue this EPA study appears, WHICH HAS BEEN FACT ALL ALONG!!!
    I'm not sure where the investigation needs to begin but AMRN needs to step up and defend the great drug they have developed..
    If I was JZ I would be furious!!!
    Oct 21, 2013. 11:21 AM | 9 Likes Like |Link to Comment
  • Does Someone Have Bad News About Amarin? [View article]
    And what about all the HEAVY buying that has taken place the last 2 days on every dip for AMRN.

    I guess people don't talk about or look at LEVEL 2.

    It's not always about what you see on your screen for the price and volume.
    Oct 9, 2013. 01:08 PM | Likes Like |Link to Comment
  • Does Someone Have Bad News About Amarin? [View article]
    How come everyone ALWAYS "knows everything" after the fact...
    Oct 9, 2013. 01:06 PM | 1 Like Like |Link to Comment
  • Does Someone Have Bad News About Amarin? [View article]
    Come on now. The ENTIRE Biotech space has been hit hard the last 2 days. All names big and small are down. This has nothing to do with AMRN.

    The problem is most retail in AMRN are weak hands and are easy to shake loose.
    Oct 9, 2013. 01:05 PM | 3 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Great article. That is the entire AMRN picture as clear as it gets! Nothing more needs to be said.

    Great job Steve.
    Sep 30, 2013. 03:02 PM | 1 Like Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    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... :)))))
    Sep 27, 2013. 03:43 PM | 4 Likes Like |Link to Comment