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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
  • Amarin Will Be Granted NCE 49 comments
    Apr 26, 2013 10:14 PM | about stocks: AMRN

    This is a reiteration that Amarin should be able to score NCE. There have been FDA actions as new developments that I was first aware of 2 days ago (was unsure of context at the time), but now some clarity is coming into play as to what those actions were. They do seem to be related to AMRN's case for NCE.

    Stocks: AMRN
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Comments (49)
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  • louieblouie
    , contributor
    Comments (23) | Send Message
     
    Steve - can you please explain the significance of the MAPP? What is a MAPP - and how does this effect our situation? As always - I appreciate your insight....
    26 Apr 2013, 10:27 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » It is the review classication for new drugs and quite possibly hold the answer onNCE determination.
    http://1.usa.gov/LzkknC

     

    This is the MAPP designation on Vascepa:
    http://bit.ly/Y3h882

     

    The named chemical is different on the MAPP (also newly updated) for Lovaza. Lovaza clearly named as cocktail mixture of Omega 3 ethyl esthers.

     

    Appears that FDA lists chemical name and formula for the included ethyl ester EPA completely different than that of Vascepa. This would support my assertion on the ethyl ester / salt topic brought up several months back.

     

    Specifically: Lovaza is listed as the following chemical; Ethyl esters of alpha-linolenic acid (C18:3 n-3), moroctic acid (C18:4 n-3), C20:4 n-3, timnodonic (eicosapentaenoic) acid (C20:5 n-3; EPA), C21:5 n-3, clupanodonic acid (C22:5 n-3) and cervonic (docosahexaenoic) acid (C22:6 n-3; DHA) (Ph. Eur.)

     

    Vascepa is; (all-Z)-5,8,11,14,17-e... acid with a molecular weight of 302.

     

    Since Lovaza has so many other ethyl esters with no specific m/weight it would be unlikley to impossible to use the mentality of EPA used as combo. In Lovaza, EPA is not used as a combo to get active moiety. I believe Lovaza's MAPP was revised a bit too, which actually suggests they should never have been granted NCE, as they did not define an active moity at all.
    26 Apr 2013, 11:52 PM Reply Like
  • crt6978
    , contributor
    Comments (56) | Send Message
     
    Steve,
    Usually I don't get excited about NCE anymore,but it looks like we might be closer to getting it in May. Wow! What a ride it has been. Not sure I'll miss the sleepless nights when we tanked,so I guess I'll be happy it's over one way or the other.
    I wonder what echo chamber garbage spin AF will say when NCE is yes?...just saying...
    27 Apr 2013, 08:04 AM Reply Like
  • louieblouie
    , contributor
    Comments (23) | Send Message
     
    Thanks! Do you think the 60 day comment period that we are in for the regs to be updated could possibly impact the decision date?
    27 Apr 2013, 08:19 AM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    Will this apply to Vascepa even though it was approved 8 months ago? I'm reading something about timeframe of when a particular drug is approved? O u think we get NCE in May? What's the date for NCE determination in May?
    27 Apr 2013, 06:34 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I cant comment on timing... nobody knows that except FDA, but this is definatley a good thing for NCE case in my view.
    27 Apr 2013, 08:40 AM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Steve I agree totally after reading the chemical compositions posted by the FDA they have really differentiated us from Lovaza. Can I get an AMEN.
    27 Apr 2013, 10:11 AM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    What's the date for NCE in May?
    27 Apr 2013, 12:58 PM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    May Orange Book will be May 17, plus or minus 1-2 days for FDA 'discretion'.... but official date is May 17.
    27 Apr 2013, 03:36 PM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Anytime second full week of May but usually on Friday which would be the 17th if not sooner.
    29 Apr 2013, 02:31 AM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Testing
    28 Apr 2013, 08:50 AM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Steve
    More "review docs" released from the FDA at some point after March 6th.

     

    http://1.usa.gov/ZGNrvm

     

    Enjoy

     

    The FDA may be leaning on making the NCE decision public at Anchor approval. I'd be surprised if they waited for the December PDUFA date, efficasy and safety have been vetted already with the SPA's.

     

    Williams
    28 Apr 2013, 09:17 AM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Steve

     

    I should have included this for my vetted comment.

     

    #6 on page 3 http://1.usa.gov/14zrSjo

     

    "The applicant conducted one pivotal phase 3 clinical trial – MARINE – to support the efficacy of Vascepa in reducing triglyceride levels in patients with severe hypertriglyceridemia. Supportive data were provided from a second phase 3 clinical trial – ANCHOR – of patients on statins with TG levels between 200 mg/dl and 500 mg/dl. This memorandum will limit discussion to the MARINE trial"

     

    The FDA has little to review for the Anchor indication, except fill and file paperwork.

     

    When your next article coming?

     

    Have you every spoken to KJ from the FDA?

     

    Williams
    28 Apr 2013, 09:32 AM Reply Like
  • yourmama6799
    , contributor
    Comments (487) | Send Message
     
    If we get Nce n May would we get Nme for Anchor?
    28 Apr 2013, 02:38 PM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Only if they approve the Anchor indication at the same time. Update in May, it would be for the Marine. I'm leaning toward the FDA granting NCE with an Anchor approval, but time could be the December 21 PDUFA.

     

    Anything that's in the FDA's hands is unpredictable.
    28 Apr 2013, 09:56 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » What is predictable is that these prices wont be around long.
    29 Apr 2013, 09:02 AM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Steve is your price target still $28-32 ?
    29 Apr 2013, 07:49 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Yes
    29 Apr 2013, 08:48 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    If everything exceeded your expectations would would be the absolue high you could see this stock going too? the reason I ask is because I am trying to decide what a good out would be if and when this stock begins to move up. Thanks for your insight
    29 Apr 2013, 09:05 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » My target remains $28-32.

     

    If you want a hypothetical situation, if timing was right and Reduce-It interim results came in positive before sNDA for Anchor approval by FDA and AMRN was still a self entity with NCE behind it, the stock could easily head toward $40.
    29 Apr 2013, 11:08 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Thanks Steve,

     

    Can you please explain the significance of the basf supplier approval announced today?
    30 Apr 2013, 07:36 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » locks down more supply, no AMRN pretty much has exclusive worldwide rights to the raw material at best possible price position.
    30 Apr 2013, 09:35 AM Reply Like
  • ItachiUchiha
    , contributor
    Comments (18) | Send Message
     
    If Amarin keeps executing you will have to raise your PT Steve
    30 Apr 2013, 12:52 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Lets get to my target first, then we'll talk.
    30 Apr 2013, 01:59 PM Reply Like
  • Inv Mex
    , contributor
    Comments (13) | Send Message
     
    Adam Fartstein should be coming out with a hit piece any moment now.
    30 Apr 2013, 02:22 PM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    Steve
    The FDA claims Icosapent Ethyl is a Prodrug of EPA. The FDA has consistantly ruled in favor with prodrugs and I again change my mind this could very well happen with the next OB update. The prodrug angle has nothing to do with the increased label for Anchor and I believe it has nothing to due with the NCE delay. The delay has been due to new MAPP's and guidance related to NCE and API labeling, none of which has been remotely negative to Vascepa's position.
    Pg. 20 for the Prodrug in the Medical Review for Vascepa
    http://1.usa.gov/ZREP5j

     

    On another note, the medical review also states Amarin can add the Anchor data to the label after REDUCE-IT is 50% enrolled.

     

    pg 10
    http://1.usa.gov/ZREP5j

     

    50% enrollment?Now?
    http://bit.ly/ZRERds

     

    A little insight into how impressed the statistician was with the Statin/Vascepa data.
    http://1.usa.gov/12RfS8K
    AMR 102 has preliminary stats:) Should see the Lipitor (prodrug) and Vascepa combo data soon after the patent NOA. It's looking like the Liptitor prodrug is a NCE as well:)

     

    Time will tell, but I see a bidding war with all this information.

     

    Williams
    30 Apr 2013, 04:55 PM Reply Like
  • Deep.Blue
    , contributor
    Comments (131) | Send Message
     
    Great dd Williams.
    1 May 2013, 07:06 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Williams, I tend to agree, although hate to guess anymore on timing. That's one error I'll admit I've missed, but heck, this is a wacky situation.

     

    I posted a blog entry to followers last week and gave a heads up that something was going on with FDA before the MAPP was issued. I did this because I had been told progress was being made with FDA. Then the MAPP came out. Without seeing any 8ks I'm encouraged that this is all good news. An 8k would mean AMRN was notified and was able to determine that a potentially negative material affect was given by FDA. That did not happen. The do not release these if it can potentially have a positive effect. That can be covered during CC.
    30 Apr 2013, 05:05 PM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    Steve, can you give some guidance on what you think would constitute a really strong 1st Qtr CC by Amarin management? After the fact there are sure to be many opinions - I'd be interested to know going into it what you believe could be game-changing comments / report out. Thx.
    2 May 2013, 01:19 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Don't want to speculate. If they meet analyst estimates, that would be a blow out qtr.
    2 May 2013, 01:59 PM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    By all indications for earnings (albeit negative), scripts and sales the company will exceed expectations. It seems like sales projections for '13 by industry watchers have been all over the place so it's hard for me to gauge what a good pace would look like to analysts or WS. IP, trials progress, ANCHOR date estimates - these all get little creedence / assigned value by same watchers. Oh, how I hope NCE is resolved in May - even if after the CC!
    2 May 2013, 02:32 PM Reply Like
  • Sanamjay
    , contributor
    Comments (5) | Send Message
     
    Another patent issued today, hoooorrraaayy
    http://1.usa.gov/NMF2zQ
    30 Apr 2013, 07:31 PM Reply Like
  • MAS-
    , contributor
    Comments (10) | Send Message
     
    Does anyone has the revised monthly scripts data? Thanks in advance for the info
    1 May 2013, 10:05 AM Reply Like
  • MAS-
    , contributor
    Comments (10) | Send Message
     
    I found the info thanks to a stockwit contributor (Bullrunner). Here is a link. The monthly data is updated and seem to be slightly higher than the weekly information we all are receiving

     

    http://bit.ly/Yj4PEH
    3 May 2013, 08:45 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » If we get so much as a fart on the CC about positive script flow confirmation and NCE granted in May, AMRN will be $12-15 overnight.
    2 May 2013, 05:22 PM Reply Like
  • david22hughes
    , contributor
    Comments (237) | Send Message
     
    Fartstein the fart master general will be quick to fill us all in if there has been a fart.
    3 May 2013, 11:27 AM Reply Like
  • Jerryg
    , contributor
    Comments (15) | Send Message
     
    Hoping management brings their "A" game to the conference call. Anything less and the stock will most likely see a haircut similar to the one witnessed after the 1st Qtr. CC.
    3 May 2013, 03:31 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » May 9th I believe.

     

    The stock will be going up from here I believe. Way up.
    3 May 2013, 04:39 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    When???? I think I speak for many as I just want to see this stock go up. This company could get $12 a share tomorrow in a heart beat (but obviously at this point that would not be accepted) if they wanted but this stock for some reason doesn't seem to want to climb over the low 7's. it is very frustrating for even the most patient of investors...
    3 May 2013, 09:36 PM Reply Like
  • Jerryg
    , contributor
    Comments (15) | Send Message
     
    I'm not exactly going to hold my breath for this stock to go up anytime soon. It seems to be in firm control of "investors" who wish to see it stay below $7.

     

    If management so much as gives us the "the next (3) months will be exciting times", shareholders can just kiss it good-bye. If management fails to have their ducks in a row with regards to providing solid guidance for Vascepa sales, the stock price will crater. If they sound like they are at a funeral, then the market will punish the stock.

     

    Management needs to provide WS with a solid game plan and reasons for pushing the price back above $8. If not, then I have to wonder if management is aiming for another 1-10 reverse split. (heavy sarcasm)
    3 May 2013, 11:35 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Steve i see Arena (arna) had some after hour issues tonight. I have not done any research on them but have seen articles comparing them to amarin and vivus. Those articles broke down these companies trying to see what company of the three will succeed. Does what occurred tonight with arena shock u at all and do u have any reason to believe bad news for amarin could be in the future?
    2 May 2013, 07:49 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » The only similarity to AMRN>ARNA>VVUS is that they all have approved drugs, are publically traded drug companies and the CEOs are all men. That's about it.
    3 May 2013, 12:43 PM Reply Like
  • Techcodex
    , contributor
    Comments (2) | Send Message
     
    Hi Steve,
    There has been a lot of speculation regarding delays on NCE. This includes FDA waiting on certain patents, citizen petition thwarting progress, anchor trial results, the expiration of Lovaza patents and now the MAPP policy updates. Not including MAPP - all other speculations on delay have been falsely connected. I am asking if the delay in NCE has more to do with a backlog? I personally know a couple of people who have worked for the FDA (obviously not the same department) and they have informed me of a backlog, indifference and laziness.
    5 May 2013, 12:56 PM Reply Like
  • golfstud
    , contributor
    Comments (54) | Send Message
     
    Have u heard anything that may make the cc on Thursday interesting? My take is that it is either a shocker or blah with nothing of any great info. Would like to hear your thoughts..thanks
    7 May 2013, 07:06 PM Reply Like
  • jimpayne1
    , contributor
    Comments (28) | Send Message
     
    Are you at all surprised that the Board is unhappy enough with JZ to look for his job? I am surprised and of course concerned. After all, he was touted as the guy who got it done once already.
    8 May 2013, 09:55 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » What are you talking about?
    8 May 2013, 10:34 AM Reply Like
  • jimpayne1
    , contributor
    Comments (28) | Send Message
     
    There is a screen in the proxy packet (recommendations) if you check the box it offers the idea that the board wants him out and if you do nothing your vote will be cast with the board. In the proxy itself the recommend his return. Very strange indeed!
    9 May 2013, 09:12 AM Reply Like
  • Attm
    , contributor
    Comments (35) | Send Message
     
    Any outlook on the odds to get NCE approval next Fri?
    10 May 2013, 10:29 AM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    Why next Friday? While we're told it can come any time it would be out of cycle with standard procedure of OB posting of information 2nd week of each month. Just wondering.... thx
    28 May 2013, 07:37 PM Reply Like
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