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  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    Caption's Keyword -
    "FDA reviewing Amarin Request to Reinstate Anchor SPA".
    Why would FDA wants to review the rescinded SPA?
    FDA could have rejected their request again very well, but FDA didn't do this for a simple reason Amarin's request has a legitimate or a valid point.
    Next, if they reinstate SPA, they need to verify whether the SPA's end point or target is significantly achieved with respect to placebo, etc.,.. with efficacy and safety.
    Needless to explain further from this point because it is anybody's guess (with a common sense) what would be the NEXT.....
    As a bio author, we expect you to write a meaningful and most importantly an UNBIASED view for the benefit of the common public.
    GLTA
    Dec 20, 2013. 12:34 PM | 5 Likes Like |Link to Comment
  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    Guys,
    Please read all the relevant FDA documents on AMRN carefully.
    As per Form - 8K published by AMRN on 29 Oct 2013,
    "........Amarin is working with the FDA to schedule a Type A meeting to discuss with the FDA, as permitted by applicable FDA guidance........"
    As per FDA, Type A means..
    "1. Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level
    2. Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new
    path forward should be discussed
    3. Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment...."

    GLTA
    Oct 31, 2013. 10:23 AM | 1 Like Like |Link to Comment
  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    The author has a meaningful comment
    "...... these studies do not say that a Vascepa like drug would not yield improvements for people who are at risk of cardiovascular disease..."
    The simplest analogy for the entire Anchor episode is
    " A Grade 10 student is ready for his annual exam. His exam questions are NOT from Grade 10 but from Grade 12. In my opinion the student cannot answer the questions and so will fail. The student will definitely answer questions and may pass but only when he enters Grade 12 and not now under Grade 10"
    Similarly AMRN would respond to FDA on CVDs at a later date when they are ready with REDUCE-IT results and not with ANCHOR results.
    FDA cannot understand this simple rule, what can we do?

    GLTA
    Oct 30, 2013. 09:48 AM | 1 Like Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    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
    Oct 26, 2013. 03:06 AM | 2 Likes Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    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
    Oct 22, 2013. 10:02 PM | Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    I totally agree with you steve.
    No one knows for sure about FDA's action on the subject on or before 20 Dec 2013.

    GLTA
    Oct 18, 2013. 12:28 PM | Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors [View article]
    Waste of time. No scientific reasoning. Tinco stuff - makes sense.
    Beating the ripped down stock, which is easy to do by anyone.
    Oct 18, 2013. 12:06 PM | 2 Likes Like |Link to Comment
  • The 3 Signs Of Apocalypse Amarin Longs Missed [View article]
    Yes, I totally agree with you Chenz.
    Still you cannot say it is NO for sure as of now.
    Oct 17, 2013. 11:56 AM | 1 Like Like |Link to Comment
  • Amarin shares crumble after negative FDA advisory vote [View news story]
    Since I am an investor in AMRN, I am curious.
    Do you mean that there is absolutely Zero chance for AMRN to win the Anchor approval from FDA in spite of yesterday's blood bath.

    If yes, Was there any such case in the past form your experience?
    Oct 17, 2013. 09:24 AM | Likes Like |Link to Comment
  • Amarin Corp.: The Mineral Oil Placebo Should Not Concern Investors [View article]
    In my opinion, Statin + V must be considered together because Statin is accepted as a CVD reduction medicine for several years in the past.
    Along with statins, this V is simply superb and nobody can beat it currently.
    Refer to Figure 1, which is FDA reviewer's graph, on page 12/115 of FDA's BD - One can easily see the superiority of (AMR 101 4g + statin) over (Placebo + statin).
    All the parameters under V are on the decrease side (that is below 0 level) with slight LDL-C up but it is almost at goal point and so far nothing is available to reduce this LDL-C on the market. Hence, this reduced LDL-C wrt to other medicines is one of the key points for success because this is one of the main indicators for CV risk reduction.
    Oct 15, 2013. 11:08 AM | 1 Like Like |Link to Comment
  • Will Cardiovascular Concerns Jeopardize Amarin's Upcoming FDA Advisory Panel? [View article]
    Ross,
    Tx for your detailed effort.

    David,
    Further to your comments, refer to Figure 1 on page 12/115 of FDA's BD - One can easily see the superiority of (AMR 101 4g + statin) over (Placebo + statin).
    All the parameters under V are on the decrease side (that is below 0 level) with slight LDL-C up but it is almost at goal point. This reduced LDL-C wrt to other medicines is one of the key points for success because this is one of the main indicators for CV risk reduction.
    GLTA
    Oct 15, 2013. 06:46 AM | 5 Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    Will,

    Just now, I happen to see an interesting & important article from the message board to share with you.
    Google - "Massive DNA study points to new heart drug targets and a key role for triglycerides" and you would find this.
    In essence, this article categorically says, "A further analysis of the massive dataset, published as a letter with lead authors Sekar Kathiresan and Ron Do from Harvard University and the Broad Institute, suggests that triglyceride levels have more impact on cardiovascular disease risk than previously thought", etc.
    - Inspiring and promising

    GLTA
    Oct 14, 2013. 05:15 AM | 1 Like Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    This is a GOOD point.
    Ignore the placebo, etc., Just using the baseline itself, AMRN is great. Hopefully Thumbs Up for AMRN.
    Oct 14, 2013. 01:49 AM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    Almost done deal for approval based on some of the following references:
    Please refer to the following:
    Section 5.5 - page 57/115 - last para & last sentence -
    "Despite these differences, in general, the effect of the mineral oil placebo on lipid parameters was small". Hence No issues wrt Mineral Oil.
    ----------------------...
    Second para, page 87/94 or 91/115 -
    "In considering the ANCHOR results, the relative improvements in triglycerides and other lipid parameters with AMR101 4g/day, compared with placebo, reflect changes hoped to translate
    into cardiovascular benefit".
    ----------------------...
    Page 58/115 - third para -
    "The applicant contends that if mineral oil reduced statin exposure, then LDL-C should have increased after 12 weeks of
    treatment, not decreased". Hence No issues wrt Mineral oil.
    GLTA
    Oct 13, 2013. 07:19 AM | 1 Like Like |Link to Comment
  • Vascepa Scripts Barrel Forward To Q2 Earnings [View article]
    What is your guess on ANCHOR approval by the end of this year?
    Jul 22, 2013. 03:57 PM | 1 Like Like |Link to Comment
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