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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
  • FDA Reviewing Panel Comments In 9-2 Vote 47 comments
    Oct 22, 2013 9:51 AM | about stocks: AMRN

    A developing story, the FDA will be closely reviewing discussion comments and questions that arose during a recent Vascepa FDA panel hearing. Actual comments are typically reviewed for FDA decisions on new drug approvals. In fact, they play a critical role and were the factors in recent weight loss drug approvals, in light of negative panel votes. Nearly 25% of panel vote are ignored by FDA (admittedly, more yes than no votes), and in each case, commentary from the panel was used as justification. Commentary from the panel on 10/16 revealed more than the usual doctor insight on the requested indication and medical need - comments at the Vascepa panel suggested clear confusion about what question was being asked and several doctors were also confused about information presented (or not presented) during the FDA's presentation:

    -Critical safety data on Vascepa omitted, yet voting question asked about safety and nearly 40 minutes taken up discussion safety

    -One doctor asked before voting to clarify and explain the question being voted on

    -One doctor asked to re-write the question or answer a different question

    -Another doctor goes on to say to the FDA that AMRN has done everything FDA asked them to do

    The FDA is a very documentation-driven (black and white) entity and the panel's commentary will clearly not support the 9-2 vote and an outright rejection on the Anchor sNDA. If anything, the FDA and AMRN must work together to come to an agreement on how Anchor gets approval on December 20th with the proper labeling language. In this case, everyone wins - FDA, patients and AMRN investors.

    Will keep following the developments, this one is going to be a photo finish.

    Stocks: AMRN
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Comments (47)
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  • dremer
    , contributor
    Comments (34) | Send Message
     
    Sorry, how do you know the FDA is reviewing the comments? Your headline makes it sound pretty definitive but is this not speculation?
    22 Oct 2013, 11:18 AM Reply Like
  • birdcage
    , contributor
    Comments (6) | Send Message
     
    Standard FDA protocol to review within 2 weeks after ADCOM.

     

    Thanks for the update Steve.
    22 Oct 2013, 05:21 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    Not sure who you spoke to. My only hope is that it isn't the same individual that had been on a panel and predicted a slam dunk for Vascepa and that the affair would be over by noon.............

     

    I'm not writing this to be contentious, its simply that the amount of people who have been wrong about Amarin could fill stadiums and I'd fill one of those seats.
    22 Oct 2013, 02:10 PM Reply Like
  • dallas1dallas1
    , contributor
    Comments (33) | Send Message
     
    I don't trust the FDA to do ANYTHING in favor of Amarin anymore. There is a clear agenda and it's not in Amarin's favor.
    22 Oct 2013, 04:40 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Hi Steve great Article.In your first sentence you a developing story.Can you explain that ,has the fda or someone in the department or Amrn stated this or are you saying that you think this is happening.Best of luck to all longs.
    22 Oct 2013, 05:14 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Steve get out of Stocktwits and come in and answer these 2 legit Questions.I have also posted much the same post earlier but its not on yet,but again who said the fda is questioning Adcom .Im thinking now that with all the energy by investors trying to change result Dec20 that if they get a NO agin we could see $1.20 and that for me is end of game and some heavy medication and it wont be Vascepa.Been honest I was always happy enough with selling my 20k shares at $10 even though I started buying at $14.Best of luck Longs
    22 Oct 2013, 05:14 PM Reply Like
  • faithdog
    , contributor
    Comments (2) | Send Message
     
    Steve -is this a significant development? Seems more like standard procedure following an Adcomm.
    22 Oct 2013, 05:14 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » not speculation
    22 Oct 2013, 05:20 PM Reply Like
  • daspi
    , contributor
    Comment (1) | Send Message
     
    Thank you Steve for the quick run. Do you still believe an approval is possible or likely? Has FDA ever gone against a 2:9 neg vote?
    22 Oct 2013, 05:20 PM Reply Like
  • rtc110
    , contributor
    Comments (2) | Send Message
     
    My concern is that there will be no objective reviewers, but that they will overlook the fiasco and quickly move forward through the process and deny Anchor. It seems there is an agenda and out only hope is to get reasonable and objective reviewers to oversee the process in hopes that an approval of anchor is warranted.
    22 Oct 2013, 05:28 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Steve has just done a runner .He just said on Stocktwits ,he will not go on seeking alpha or Stocktwits.Its getting scary ,Is the Ship sinking and holding 20k shares.I sold 11450 Elan at 12 to get into this stock at 14/12/8/7/5 and if I had to sit on Elan its now $16 so Id have close to $200,000 but now Ive got 40,000 and I also put 30,000 along with Elan sale.This is an serious mess,especially when your wife tells you yesterday that we are doing great in Elan.Yes I didn't tell her,Im sure Im not the only person in this trouble.Best of luck everyone
    22 Oct 2013, 05:50 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Reason why is I am in direct contact w/ company and it would not be appropriate to post anymore at this time.
    23 Oct 2013, 06:25 PM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Excuse me while I kiss the sky. You are in direct contact with the company. Me to. But I also have Icahn on my cell phone contacts list. I can't comment because I am in direct contact with Icahn, but he tells me he is reviewing the Adcomm. Steve, great opportunities, thank you for your priceless advice.
    23 Oct 2013, 10:34 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    steve one last statement before you go ,we need something to hang on to.Thanks
    22 Oct 2013, 06:00 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    hang on to the fact that V and amrin corp. is doing everything they can to ensure the success of this product.. the market that it will serve is huge.. this drug will be the best selling drug ever,, not just domestically,, internationally. as well,, im in that same boat as you, my feelings are so blown,, my dd and my belief are a sure thing. im NOT EVEN going to wish you good luck... why did you invest in V? well thats what I tell myself.. and that's why IM staying fast..PERIOD!
    22 Oct 2013, 07:51 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    The Big plus for Amarin is they are the same as Elan ,they are an Irish Company and when several companies were bidding on iElan all the media was saying great buy because of low tax in Ireland.Granted they had tysabri a billion dollar drug but everyone was talking low tax,so lets hope the same applies to Amarin and it gains us a few dollars.We are gonna get murdered dec 20th if its a No and the sad thing is that it was 7.20 few days before NO Adcom so that huge drop should be enough but Wall street always wins.
    I am upset that all the directors including ceo from 8 up to 15 and at 15 the shorts piled in and more as the stock went down.If I ever see this happen again if I ever have any money to invest again Im out no matter how good the drug is.I have to wish everybody luck because we need it.ILL get up for 8am Mass Christmas Day if you give us a YES [fda].
    22 Oct 2013, 08:32 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    @boat,, here is some insight,, why would anyone fire their employees when they have a great product.. and their sales are doing ok... mabey they don't need those employees, mabey, just mabey,, those employees would be fired anyway, when the company gets sold.. why would j z fire his staff,, when he needs sales against marine,, mabey because..
    22 Oct 2013, 08:46 PM Reply Like
  • SJunk
    , contributor
    Comments (17) | Send Message
     
    Steve,
    As per the latest press release, AMRN reduced it's workforce by 50% to achieve the company's' goal like completion of reduce-it, etc.
    Under the current scenario, this may be one of the good steps by Joe for the company's future.
    But the market is so stupid, on hearing this press release, huge negative reaction and the price drops !!!.
    I cannot understand the sentiments of the stupid market.
    GLTA
    22 Oct 2013, 10:02 PM Reply Like
  • TincoMonkey
    , contributor
    Comments (92) | Send Message
     
    The market reaction is more likely due to what looks like Joe Z rolling over and not fighting the ADcom outcome.
    23 Oct 2013, 02:51 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Look I don't want to seem negative but when Joe had his press release after disaster and said he was gonna look from top to bottom of the company to save money.I new he wasn't gonna look at the top to take money from huge paying directors he went to the bottom of the pile or what he though was the bottom of the pile and fired the people on the ground selling the drug lol.
    When Elan hit hard times just 2 years ago I was at the AGM in Dublin and Ceo Kelly Martin said all directors were been cut salaries and he himself was taking a huge salary drop .Big positive news right after on all media and stock went up.Its a no brainer ,move offices to smaller offices shut them down get back to Dublin ,sack the secretary take the calls himself sack pr guys they are no good and what is he doing hiring steve giving him money and sacking the guy that's knocking on the doors of Doctors.Sad Sad.Cant believe they all sold at $14 and left us at $2.He and his directors knew there was trouble ahead.He right about one thing but a year early in saying it .The next 90 days will be fun.All aboard the Amarin Rollercoaster.
    22 Oct 2013, 11:10 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    @xtram you said they have a great product.They have a safe product but Adcom and probably Dec20 fda don't think they have a great product.Elans drug tysabri was fast tracked by fda that's a great product ,it was a powerful drug it cured people of ms.Amarin is safe as far as Anchor /Fda /Media and a huge amount of doctors are concerned, but they don't think its got great or even good Efficacy,thats a HUGE problem for us as shareholders at $2
    22 Oct 2013, 11:21 PM Reply Like
  • david22hughes
    , contributor
    Comments (237) | Send Message
     
    JZ's biggest mistake was that quote when he said that if there was an offer of $30, $40, $100 we can talk. He basically announced to the world that a) he could be bought out and b) he's greedy. He and Amarin shareholders are now learning the hard way that Big Pharma determine the buyout price and nobody else. They will use the FDA, market manipulators, dodgy Caymen Island loan sharks etc to get this drug one way or the other.

     

    Because JZ can be bought out and is greedy all is probably not lost for the shareholders. Some kind of deal will be brokered over the next few weeks and months. A 50% reduction in staff doesnt suggest they have any expansion plans imminent does it? It's a move of a company and a CEO that has accepted its fate. Remember that JZ and the board still hold a substantial amount of shares and greedy Joe will go to Big Pharma with tail between legs and try and get as much as he can knowing that he now has ZERO chance of going this alone.

     

    I still say ANCHOR gets rejected and they are sold somewhere between $5-10/share. There is a very slim possibility that if he agrees to a deal whereby whatever happens with the ANCHOR PDUFA he agrees to sell, ANCHOR mysteriously then gets approved and Pfizer or whoever get their drug but at a higher premium obviously. Amarin may be in negotiations now as to what that premium will be. That theory is a long shot but you never know whats going on behind closed doors. Huge blocks of shares are currently being bought up.

     

    Steve, I know you bought more shares at $8 or thereabouts and you obviously still believe all is not lost. Simple question, the share price is now $2 and change, are you buying more?
    22 Oct 2013, 11:53 PM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    Expansion to what if they don't get ANCHOR? Appears to me from the wording of the PR that they let go the 50% of reps that weren't generating sales - think I read something where the 50% they kept were getting 75% of total sales? Makes sense to trim at this time - may have been a knee-jerk reaction unless quick talks with the FDA convinced them no ANCHOR of any type (conditional or changed label) was coming Dec 20. Cutting those laggard reps will save them over $20M/yr - equivalent to running REDUCE-IT once enrollment is finished.
    23 Oct 2013, 11:55 AM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Steve will not answer direct questions. New Moniker will be Steve GreatOpportunities Innuendo Rosenman!
    23 Oct 2013, 10:47 PM Reply Like
  • david22hughes
    , contributor
    Comments (237) | Send Message
     
    "A 50% reduction in staff doesnt suggest they have any expansion plans imminent does it?"

     

    That was a rhetorical question, didnt need answering because the answer was obvious. The ANCHOR patient population is an estimated 10X the size of MARINE for which they had about 275 sales reps. You dont cut that number to save on a few millon $'s if you are confident of ANCHOR approval. You maintain it and announce how you plan on substantially increasing the sales force post ANCHOR approval.

     

    Here's a question for all the Amarin bears out there who have magically appeared out of the woods in support of the FDA and the farcical ADCOM and vote. When you go for a medical check up, blood samples are taken and tested for your total Cholesterol level, your LDL level and your Triglyceride level. Why do doctors bother to do this if high triglycerides are not a problem and not correlated with heart disease? Are the FDA now saying that only triglycerides >500mg/dL are of any importance? Don't bother treating high trigs because we have no concrete evidence and hard data to support the claim that lowering high trigs has any CV benefit until the REDUCE-IT study is completed. Your trigs are 502mgs/dL and holy smokes you need meds to reduce them but 402mgs/dL, 499mgs/dL, no, no worries there, you'll be fine! That JELIS study may as well have been conducted on rats its of so little relevance apparently.

     

    The whole thing is a joke.
    23 Oct 2013, 11:23 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    let me write that down.. so steve is who? new Moniker,,and gr8... so he has two new names, or is one name old, and there is a new name with the same new steve? explain,, so if steve is on first base,, and gr8 is on second.. and that new moniker is on third.. who made the home run.. joe.. z did he make the home run. yea he did and he hit a grand slam..
    25 Oct 2013, 06:59 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    mr. david.. thanks so much... did you read that post on inverstorvillage #1005.. its on the mark just as your post are.. soon and very soon... we could see that change that is needed for a new indication..
    25 Oct 2013, 07:03 PM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Hilarious x-,man - So you know, between the last secondary and pre-adcomm runup, greatopps was on the Yahoo message board touting his brilliance. Same schmuck who was been spewing his sources, bs, and innuendo from 16 on down. And a meager 1.3 runup and he wanted credit for being right.
    25 Oct 2013, 07:43 PM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Sure, soon, yes very soon. Sure.
    25 Oct 2013, 07:45 PM Reply Like
  • biobetter
    , contributor
    Comments (79) | Send Message
     
    Steve the press release gave the impression the layoffs are reaction to communications AMRN has had with the FDA after AdCom . Do you know if AMRN has been talking to the FDA in the few days since AdCom? Thanks for the article.
    23 Oct 2013, 10:09 AM Reply Like
  • dremer
    , contributor
    Comments (34) | Send Message
     
    If FDA was reviewing the adcom fiasco why not wait 2 months before firing 50% of the sales force? I hope the FDA comes to it's senses and gives conditional Anchor approval with label warning, but AMRN clearly thinks it's a long shot
    23 Oct 2013, 01:29 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    STEVE POSTED ON STOCKTWITS YESTERDAY THAT HE WONT BE COMING BACK INTO SEEKING ALPHA[THIS ROOM] AND STOCKTWITS ,HE IS GONE TO WORK FOR AMARIN.
    23 Oct 2013, 01:42 PM Reply Like
  • coumery
    , contributor
    Comments (28) | Send Message
     
    Wait, I thought he was working for Amarin all along. Now it's official?
    23 Oct 2013, 10:49 PM Reply Like
  • TincoMonkey
    , contributor
    Comments (92) | Send Message
     
    How did Adam F. know how the advisory panel would vote before the meeting. On reflection, the voting does seem extremely odd and illogical. I wonder if Adam had any form of inappropriate contact with some of the committee members. I can't think of another possible way he could have known. It's not as obvious as that 12,000 put purchase right before the blow-up but it's just as suspicious IMO. I think an investigation of TheStreet and Adam might be warranted here.
    23 Oct 2013, 02:46 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    Tinco, I know what you mean, but AF said bad adcom for ARNA last year, after that he said no approval dor belviq by FDA, and at same time no approval for Marine . Three times wrong in a few months. And since then he always has been negative with both companies. If you try and try and try ... It's possible that you get it at last.
    23 Oct 2013, 06:02 PM Reply Like
  • Quishayk
    , contributor
    Comments (3) | Send Message
     
    Steve,
    why is your article NOT on Yahoo Finance news?
    23 Oct 2013, 06:25 PM Reply Like
  • Quishayk
    , contributor
    Comments (3) | Send Message
     
    Steve,Can you please add your article to Yahoo Finance News? Thanks.
    23 Oct 2013, 06:25 PM Reply Like
  • Quishayk
    , contributor
    Comments (3) | Send Message
     
    Long AMRN
    23 Oct 2013, 06:25 PM Reply Like
  • JohnCappello
    , contributor
    Comments (35) | Send Message
     
    Type A" meeting with FDA officials is venue & next step to resolve disputes with SPAs

     

    "Type A meetings should be scheduled to occur within 30 days of FDAs receipt of a written
    request for a meeting from a sponsor or applicant for a PDUFA product. If the sponsor or
    applicant requests a date for the meeting that is beyond 30 days from the date the Agency receives the request, the meeting should be scheduled to occur no later than 14 days after the date requested."

     

    ----------------------...
    see page2

     

    http://1.usa.gov/1a4Y36A
    25 Oct 2013, 09:56 AM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    A Type A meeting can't be scheduled if the FDA does not inform the sponsor in writing IN ADVANCE that a new issue has arisen that gives them cause for concern - no such letter was written to AMRN - that would be a material event and would have had to be announced in an 8-K. That's the crime that was committed here, besides AMRN not getting the BDs weeks in advance of the AC like rules state - the FDA unilaterally changed the topic and voting question of the AC without informing AMRN, which is why they appeared to be so unprepared - they had know idea what was coming down on their heads, could not possible have been ready. This was akin to a murder trial where the defendant's attorney was not appointed until the day the trial starts!
    25 Oct 2013, 03:52 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    thanks for the link.. I hope the dec date gets pushed back.. I think that would be a great positive for us...so much do digest and process,, thanks for your work, involving amrn corp.. keep it up.
    25 Oct 2013, 07:09 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    mr john.. could you give me some insight on the bd'd a novice question.. they are required to release them just 2 days before.. adcom right..?
    25 Oct 2013, 07:15 PM Reply Like
  • SJunk
    , contributor
    Comments (17) | Send Message
     
    Guys,

     

    May be a GOOD news and Steve might be correct as well.

     

    ZGNX was voted a BIG NO by adcom (11 no & 2 yes) but was approved by FDA yesterday in spite of it's safety concern. What a great news!!!
    Compare this news with AMRN's adcom !!!! - In AMRN case - No safety issues at all with many positive plus points !!!
    I will leave it to you guys regarding the FDA ruling on AMRN anchor.

     

    GLTA
    26 Oct 2013, 03:06 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    Unfortunately, this is not about science or safety concerns like ZGNX case.
    This is about an irish pharma without an american partner .
    "They" won't let Amarin going alone in Anchor market.

     

    This is about money, and that's the reason why we have no chance of any approval by December until partner be announced.
    26 Oct 2013, 07:31 AM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    well everyone has left the room for days so ill put out the lights as fda have hit steve a knockout.Im afraid he wont get up from this .best of luck because your gonna need a lot of luck because the science only got me from 15 to 2 .Huring bad.WHERES THE FCUKING DOOR
    30 Oct 2013, 10:23 AM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    @ boat,, do you think that your the only one who let science rule your investment decision.. and now.. we all have to,, deal with the fda.. not the studies or the science...,, little did we know,,, and you still bash steve.. this investment belongs on your conscience.. aint got nothing to do with sr, fight the fda,, not everybody else..
    30 Oct 2013, 04:54 PM Reply Like
  • same boat
    , contributor
    Comments (14) | Send Message
     
    Fight the FDA are you serious.Listen I phoned my broker when Amrn was $15 morning of approval and I said sell it all and he said wait sell 50% as wall st says its going to $30 so not only did I not sell but I bought at 14 /13/12//8/7/5/.The point is he said why are selling at 15 and I said its just fish oil and I got burned before with Amrn when the same thing happed with Huntingtons and investors lost everything it went to a 10 for 1 split .It was a hard sell this drug far to slow in sales and JZ sounds like a hit guy from a Mafia Movie .
    We all lost big and The FDA will win and Amrn hopefully will get sold for $4 and we can all move on but by the looks of it I think the shorts are gonna take this down to 99 cents when JZ speaks next week .Steve is probably a nice guy but we were like sheep.Im happy in that for the second time ive been shown how corrupt stock market is.I don't need to loose all my money for a third time.Best of luck to everyone.We have almost finished the rollercoaster ride.
    We have our health that is suppose to work but there is not a minute has gone buy since Adcom that I haven't fet sick to the pit of my stomach how the hell I lost all my money .
    31 Oct 2013, 05:09 PM Reply Like
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