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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
  • Substantial Shift Upward In Amarin Stock Likely After Hearing From FDA 15 comments
    Mar 29, 2013 10:20 PM | about stocks: AMRN

    While NCE may be a continued psychological overhang, a potential major catalyst, possibly more important than a favorable NCE ,is set to come any day now...

    I am referring to the acceptance of AMRN's sNDA for Anchor by FDA. Many may overlook the event and assume this is just normal process. But you'd be missing something - a possible massive mitigation of risk for a pharma acquirer. With Anchor, it is highly unlikely outcomes trial will be needed to market to the larger indication. But, the FDA can confirm this for AMRN, either at sNDA acceptance (any time now) or FDA approval of the indication (later in the year). To be honest, I'm not 100% sure which one is most likely in this case and I am trying to confirm now.

    Once confirmed, pharma companies would have what they need, a clear picture on when they can go to market for Anchor. Again, the assumption is no issues and no outcomes required but if you were going to fork up billions for AMRN, you would need to make sure- a heck of a lot more important than NCE.

    Stay tuned, will get interesting fast.

    Stocks: AMRN
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Comments (15)
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  • coopman98
    , contributor
    Comments (69) | Send Message
     
    Hope to see this come to fruition. We need something to get us moving. Do you expect sNDA by april15?
    Thanks
    29 Mar 2013, 11:06 PM Reply Like
  • onecardchuck
    , contributor
    Comments (40) | Send Message
     
    Steve,

     

    I agree with you about this point and so does Leerink Swan. Many of the shorts are still playing this for an issue with Anchor or an outcome study needed to get Anchor. However, I am with you as the Anchor Trial and Reduce it substantially underway should be enough to allow them to sell into the 200 - 500 group, but it is the FDA and sometimes you never know. However this is kind of a triple threat because if we get sNDA acceptance with no issue's or outcome study needed then shorts will have to cover, BP becomes very interested and rumors will fly, and script counts and NCE will become a thing of the past.
    30 Mar 2013, 01:41 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » confirmation of no outcomes and nce gets us to that premium $$ with multiple bid situation. very dangerous to be short through Q2 IMO. Ram was right when he said in our interview its not a question of if, its when and who...
    30 Mar 2013, 09:58 AM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Per Fda the only requirement to approve anchor was that the outcomes study is well under way. I CONFIRMED this w amrn 2 weeks ago. Do some of you think that the fda will change their mind? If they do that would be ridicolous. if thats the case then all diabetes drugs and other meds should have to do a year outcomes study. Everyone knows high trigs is bad just like high blood sugar. If a med lowers blood sugar do we really need an outcomes study to prove thr lowering high blood sugar benefits people. THE SAME way we know high trigs are bad so do we really need an outcomes study to show that before approval? If so that would be ridicolous.
    30 Mar 2013, 08:46 PM Reply Like
  • bravo33
    , contributor
    Comments (60) | Send Message
     
    DNDN ...... Sorry to repeat, but this surprises me. So you're saying you got confirmation from FDA & AMRN that ANCHOR would / could get approval based on showing outcomes study was substantially underway? Aren't we already there today? Thanks - sorry if I've misunderstood your comments.
    31 Mar 2013, 12:33 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » DNDN- agree, but there are investors looking for confirmation.
    31 Mar 2013, 10:26 AM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Correct. I meant 6 year outcomes for all meds. Yes it would be good confirmation.
    31 Mar 2013, 11:13 AM Reply Like
  • mjr221
    , contributor
    Comments (15) | Send Message
     
    Any reason to think the FDA wouldn't take the full amount of allotted time to approve the sNDA? That would put us into may.
    31 Mar 2013, 09:44 PM Reply Like
  • homebuilder_watcher
    , contributor
    Comments (94) | Send Message
     
    Actually scripts last week were 1406 so up 18.7% WoW
    1 Apr 2013, 12:34 AM Reply Like
  • homebuilder_watcher
    , contributor
    Comments (94) | Send Message
     
    @supradsw: $AMRN Script numbers out. 1669 vs. 1223 last weeks #'s! A good increase indeed!
    1 Apr 2013, 12:50 AM Reply Like
  • homebuilder_watcher
    , contributor
    Comments (94) | Send Message
     
    mowadeeb, how many shares short are you?
    1 Apr 2013, 08:17 AM Reply Like
  • BiotechBillionair
    , contributor
    Comments (58) | Send Message
     
    The ride starts this week.
    -first Anchor patent tomorrow '520!!!
    -Wed. Rumored JPMorgan Amarin Meeting (flyonthewall)
    -AZN has met with JPMorgan twice in the last three weeks (flyonthewall)
    -Feb IMS monthly NOT leaked (SR 3 to 4 times?)
    -End of the second week of April?
    -sNDA acceptance with no outcomes for Anchor first week of May
    -Adumb Fearstain is oddly quiet...
    1 Apr 2013, 08:32 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » I believe AZN/AMRN meetings un-related - they are 1:1 presentations to JPM in different citities,I believe.
    1 Apr 2013, 10:37 PM Reply Like
  • homebuilder_watcher
    , contributor
    Comments (94) | Send Message
     
    Looks like AZN may be even more desperate for revenue?'

     

    AZN, ACT, TEVA
    4 hours ago A district court has ruled that a patent protecting AstraZeneca's (AZN) billion-dollar Pulmicort Repsules asthma treatment is invalid, opening the way for Actavis (ACT) to launch a generic version. The ruling won't affect AstraZeneca's 2013 revenue guidance, but it will hurt royalties that the company receives from Teva's (TEVA) version of Pulmicort. It's a further blow for AstraZeneca as it restructures amidst a patent cliff. (PR)
    2 Apr 2013, 07:50 AM Reply Like
  • ajbrzoz
    , contributor
    Comments (45) | Send Message
     
    Steve, just saw this FDA document posted on iHub and Stocktwits. Skip to 2nd page: http://1.usa.gov/YeLjdA
    9 Apr 2013, 08:50 AM Reply Like
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