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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
  • Fish Oil Study Linking Prostate Cancer Risk A Scam 34 comments
    Jul 12, 2013 11:58 AM | about stocks: AMRN
    • OTC grade fish oil
    • Low doses
    • Poor study design
    • Suggest plant based Omega-3 did not have the effect, yet they are the same molecular structure of DHA/EPA
    • EPA not cited as prime suspect agent
    • Deemed inconclusive by leading cancer publications
    • Deemed completely irrelevant by me


    CRN SAYS NEW STUDY ON
    OMEGA-3 CONCLUSIONS ARE OVERBLOWN

    WASHINGTON, D.C., July 11, 2013-In response to a new study, "Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial," published yesterday online in the Journal of the National Cancer Institute, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, today issued the following statement:
    Statement by Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN:

    "The numerous benefits of omega-3 fatty acids from foods (like salmon and sardines) and dietary supplements are well-established for men and women in all stages of life-and this new study does not change those recommendations about the importance of this nutrient. Hundreds of studies over the past two decades have shown omega-3 fatty acids to have positive effects associated with cardiovascular health, perinatal health, inflammation, cognitive function, or cancer. Collectively, this body of research serves as the basis for numerous recommendations from respected organizations, scientific boards and healthcare practitioners that Americans get omega-3 fatty acids in their diets.

    While we encourage researchers to continue to study omega-3 fatty acids with an open mind, it is counterproductive when studying nutrition for researchers to promote their study as if it were the only piece of research that counts. In this case in particular, it is especially disingenuous for the researchers to make the kinds of assertions we've seen in the press, given their results are in stark contrast to previous epidemiologic studies1 that not only demonstrate no correlation between omega-3 consumption through fish and/or supplementation and the risk of prostate cancer, but in many cases also showed a protective effect against prostate cancer.

    Further, the researchers were quick to blame dietary supplements even though there is no evidence that anybody in this study took fish oil dietary supplements. In fact, the study demonstrates no cause and effect; it can only purport to show an association between higher plasma levels of omega-3 fatty acids and those whom the researchers advise had an increased rate of prostate cancer.

    One should also consider whether this study could have simply been measuring a biomarker reflecting recent intake of fish or fish oil supplements in a group of high risk cancer patients that had been told to increase their EPA and DHA levels, as compared to a group of non-cancer patients that had not been told to consume more EPA and DHA. Plasma levels of EPA and DHA reflect very recent intake and are considered a poor biomarker of long term omega-3 intake especially when compared to red blood cell levels, which reflect medium term intake. A single fish oil dose (or hearty serving of fish at lunch) results in >100 percent increase in plasma omega-3 levels. So looking at plasma levels in healthy and sick people may only provide insight into the recent habits of these individuals.

    Additionally, the study's conclusions are also limited by the fact that the study was not designed to evaluate the question the researchers sought to confirm.

    The American Heart Association, the World Health Organization (WHO), the U.S. Institute of Medicine's Food Nutrition Board (IOM FNB) and the 2010 Dietary Guidelines all have current policies advising Americans to eat more fatty fish to get the benefits of omega-3 fish oils. It is highly unlikely this one study will change that advice. Omega-3s can also be obtained by taking one of the many supplement products on the market. For those consumers who have concerns about prostate cancer or other questions about omega-3 fatty acids, we recommend speaking with your doctor or other healthcare practitioner."

    Stocks: AMRN
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Comments (34)
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  • coopman98
    , contributor
    Comments (69) | Send Message
     
    thanks again for helping straighten out this confusion.when will the continued bleeding end? have you had a chance to check out anything about the secondary? thanks again
    12 Jul 2013, 12:49 PM Reply Like
  • sharinky
    , contributor
    Comments (147) | Send Message
     
    It is amazing how a crappy study like this can go viral.
    12 Jul 2013, 01:15 PM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    This is the second broad public attack against "fish oil", and I strongly suspect specifically designed to target AMRN's new highly refined/pure EPA in Vascepa, in the last several months - first was that utter BS junk science Italian "study" - but this one hit national airwaves big time. The "science" behind this analysis is even worse than that of the Italian study, and that's saying something!

     

    The b*stards trying to torpedo AMRN's pps and V sales are stooping to unbelievably low levels now, and if you don't think anti-AMRN people (shorts?) were behind this new scare tactic you'd better take your tinfoil hat off and start paying attention. They created a national panic overnight over a TOTALLY INVALID "study", paid for by whom, I wonder? This scandal should get every Fed agency off their collective asses to start immediate investigations - the SEC, FDA, FBI - EVERYONE! Do I actually think anything will ever come of it? Nope. Unless someone knows people in very high places to get Congress riled up too.

     

    Doubtful GSK was part of it - think they want another Avandia scandal on their hands? And there are already (?!? In less than 16 hrs?!?) ambulance chasing lawyers advertising for clients who took Lovaza and developed prostate cancer:

     

    http://bit.ly/1bvb2TM
    12 Jul 2013, 02:06 PM Reply Like
  • Jolk
    , contributor
    Comments (216) | Send Message
     
    Steve, this study was done by the NCI, published this year, 2013!

     

    Why aren't they the ones being touted by all the news outlets, like CNBC?

     

    http://1.usa.gov/10PrU30
    "Eicosapentanoic acid (EPA) intake was related to decreased risk of fatal prostate cancer (HRQ5 vs. Q1, 0.82; 95% CI, 0.64-1.04; Ptrend = 0.02)."

     

    Dietary fat, fatty acids, and risk of prostate cancer in the NIH-AARP diet and health study.

     

    Pelser C, Mondul AM, Hollenbeck AR, Park Y.
    Source
    Cancer Prevention Fellowship Program, National Cancer Institute, 6120 Executive Blvd., EPS 3025, Bethesda, MD 20852, USA. colleen.pelser@nih.gov
    12 Jul 2013, 02:12 PM Reply Like
  • sharinky
    , contributor
    Comments (147) | Send Message
     
    You have to have a really bad study to come up with shocking news, that is actually news worthy.
    12 Jul 2013, 02:19 PM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    "Why aren't they the ones being touted by all the news outlets, like CNBC?"

     

    Because their study is full of facts disproving the wild accusations contained in the other BS one? And/or the food producers contaminating everything with the supposedly "healthy" soybeans and soybean oil, which contain high levels of alpha-linolenic acid (ALA), which IS implicated in prostate cancer, are trying to shift the coming blame to OTC fish oil supplements instead? The same pr*cks that poisoned everyone with HFCS, causing an international obesity epidemic from metabolic syndrome and diabetes?
    12 Jul 2013, 02:31 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    Thanks Steve. The damage is already done. It's incredible how weak and helpless the price is when it's attacked in such way. I am of those who think there is a master plan running but this last attack has been the straw that breaks the camel. Now more than never I think we need a Big Daddy who can protect the company from this evil manipulation. And we need it "asap". Many shareholders simply cannot allow to see the price so low because a potential "margin call". Many of us (longs) will be forced to go SHORT to cover just some losses if the price goes to fill that huge gap so close right know. And then, going short, we become in part of the problem. Curious, uh?
    12 Jul 2013, 04:56 PM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    If we longs aren't happy about this, how do you think Citi and Jefferies clients are feeling today after paying a 30 cent premium for their shares - or viewed from the other way, being down 30 cents, losing a total of $6.5M on their investment(s) the day the offering closed? Whatever happened to the bookrunners supporting the share price? Is Citi just as crooked as Goldman Slacks, or is that a really dumb question?
    12 Jul 2013, 06:08 PM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    "Is Citi just as crooked as Goldman Slacks, or is that a really dumb question?".....no offense, but since you asked...it's a dumb question :)
    12 Jul 2013, 10:12 PM Reply Like
  • fairplayplease
    , contributor
    Comments (3) | Send Message
     
    Doubtful study as the authors even stated "We did not evaluate the validity and reliability of our assessment of reported specialty supplement use".

     

    Since "Vascepa is the first and only prescription Omega-3 to be free of DHA' this study should help differentiate Vascepa as far superior drug compared to the rest of the competitors.
    12 Jul 2013, 04:56 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Agree guys, let's just hope in our situation, nice guys don't finish last :-)

     

    I've been adding down here at these insane levels. I'll laugh my way to the bank when AMRN starts picking up and reaches new highs toward Anchor.
    12 Jul 2013, 04:57 PM Reply Like
  • Samuel-
    , contributor
    Comments (103) | Send Message
     
    It does seem tempting... thanks for sharing :-)
    12 Jul 2013, 08:34 PM Reply Like
  • fairplayplease
    , contributor
    Comments (3) | Send Message
     
    A good read from today's article by Dr Sears at Zone Diet in response to the recent fish oil article http://bit.ly/1b7Czfm

     

    * Results in the fish oil study may be statistically significant but "the differences definitely are not clinically relevant."

     

    * The analysis in the fish oil study is meaning less per Dr Sears' :
    "I have been very consistent over the years in stating that to have an impact on reducing inflammation, you have to have EPA levels greater than 4% of the total fatty acids, AA levels less than 9% of the total fatty acids and an AA/EPA ratio between 1.5 and 3. As you can see, the subjects in this article were nowhere close to those parameters. In fact, I would say all the subjects in this trial were identical relative to AA, EPA and the AA/EPA ratio. In other words, the analysis is meaningless."
    12 Jul 2013, 04:57 PM Reply Like
  • moeschempf
    , contributor
    Comments (30) | Send Message
     
    Excellent review of a crappy article. Hard to believe it got the amount of publicity it did over the past two days.
    12 Jul 2013, 06:02 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    The articles and study are being thoroughly trashed. This will backfire and go in our favor. Especially with ambulance chasing lawyer firms already putting out adds against GlaxoSmithKline and Lovaza. GSK will be forced to respond. AZN with its recent acquisition of Omthera will be forced to respond. Big Pharma is already in the fight whether they like it or not.
    12 Jul 2013, 08:26 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » Getting AMRN at $5 and change feels like I should be handcuffed--it's like stealing candy from a baby (or a short)
    13 Jul 2013, 03:59 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    I've been adding at this level but if you see the chart there is a huge gap unfilled bellow $5.20 ... That is really scary, terrifying ...
    13 Jul 2013, 07:20 AM Reply Like
  • Jolk
    , contributor
    Comments (216) | Send Message
     
    AMRN cash per share (fully diluted) is over $1.50 about now, right?
    It just seems hard to believe that there would be any reason to fill a gap, though we all know no one thought we'd be hovering $5.00 at this time.
    13 Jul 2013, 08:18 AM Reply Like
  • jimpayne1
    , contributor
    Comments (28) | Send Message
     
    The only thing promising in light of your comment is the secondary. It was snapped up quickly by big money at 5.60. Du you think WS is going to take a hit like that? Go under five where its not even salable anymore? This would almost be good for a movie plot!!!
    14 Jul 2013, 09:32 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    I hope you're right and this monday things start to change. Hell is very close ...
    http://bit.ly/12ytaJ9
    14 Jul 2013, 01:35 PM Reply Like
  • Jolk
    , contributor
    Comments (216) | Send Message
     
    Amarin has over 300 million in cash, OMTH sold for what, 400 million pending milestones?
    14 Jul 2013, 01:43 PM Reply Like
  • fairplayplease
    , contributor
    Comments (3) | Send Message
     
    Here is another interesting interview/critic on the fish oil study from a supposed expert on prostate cancer (only audio). Thanks to justanotherday from stocktwits for posting the link
    http://bit.ly/15qkfHV
    13 Jul 2013, 08:39 AM Reply Like
  • Jolk
    , contributor
    Comments (216) | Send Message
     
    http://bit.ly/16AbJFJ. Dr. Anthony D'Amico, seems like just the person you'd want to ask... That interview slams the door on the 'valueless' study.
    13 Jul 2013, 09:32 AM Reply Like
  • Jolk
    , contributor
    Comments (216) | Send Message
     
    http://bit.ly/18fRCmZ

     

    Omega-3 fatty acids: mechanisms underlying ‘protective effects’ in atherosclerosis

     

    Current Opinion in Lipidology:
    August 2013 - Volume 24 - Issue 4 - p 345–350
    doi: 10.1097/MOL.0b013e3283...
    HYPERLIPIDAEMIA AND CARDIOVASCULAR DISEASE: Edited by Paul N. Durrington
    13 Jul 2013, 11:53 AM Reply Like
  • jackster101
    , contributor
    Comments (16) | Send Message
     
    Redacre note out today

     

    Amarin Corporation PLC (NASDQ:AMRN
    Quick Take

     

    Amarin (NASDAQ:AMRN) sold 21.7 million shares (ADRs) in a secondary offering which was announced on Monday. This increases shares outstanding from 150 million to approximately 172 million representing some 14 percent dilution. The over-allotment option, if exercised, is another 3.25 million shares. The offering priced at $5.60. AMRN closed the week at $5.27, 6% below the offering price.

     

    Details

     

    Here's what we wrote to our beta testers on Monday:

     

    The timing of this offering, in our view, could not be worse. AMRN is nearly at a 2-year low, and this offering will undoubtedly come in at a discount to today's closing price of $6.17. Already in the post market, AMRN is trading down 10.7% to $5.51.

     

    With $201 million cash on had as of their most recent 10-q, and a likely cash burn of say $60 million, AMRN should end Q2 with $141 million or so. The company could easily have waited a few weeks or months to let the stock run up before doing a cash raise. On the other hand, with an imminent catalyst in the form of the October 16th advisory committee meeting, perhaps management viewed chances for getting a deal done closer to the catalyst as unlikely.

     

    Participating in this secondary at these prices is likely to be a good bet as AMRN gains further attention in late August through September for a run-up play ahead of the Ad Comm.

     

    Next month it will be interesting to see if there is a significant change in the short interest for AMRN. Based on the latest reported numbers, AMRN had 24.66 million shares short before the offering. The 21 million share offering gave shorts a great opportunity to cover. If there is a large decrease in short interest, this potentially takes some of the momentum out of a potential run-up ahead of the Advisory Committee meeting for Vascepa's high triglyceride indication (recall Vascepa is already approved for those with very high triglycerides.

     

    In their latest quarterly report AMRN had indicated that a cash raise would be required for the ANCHOR indication:

     

    In order to fund the Company’s commercialization plans, in particular to fully support the marketing and sale of Vascepa in the ANCHOR indication, the Company will likely need to enter into a strategic collaboration or raise additional capital.

     

    From the prospectus for the offering we note the following use of funds:

     

    We intend to use the net proceeds from this offering to continue the commercial launch of Vascepa® (icosapent ethyl) capsules in the MARINE indication, prepare for and commercially launch Vascepa in the ANCHOR indication, if approved, advance our REDUCE-IT cardiovascular outcomes trial, and for general corporate and working capital purposes.

     

    ...

     

    Based on our current operating plans, we believe the proceeds from this financing, together with our current cash and cash equivalents, will be sufficient to fund our operations, including the potential need to expand our commercial presence following any approval of Vascepa in the ANCHOR indication, alone or in conjunction with commercial partners, through the end of 2014.

     

    So AMRN has cash through the end of 2014, and clearly indicates that an expanded sales force will be needed to market in the ANCHOR indication. In the company's Q1 2013 quarterly report (linked above) the company was placing greater emphasis on finding a strategic partner and self-commercialization in the ANCHOR indication was talked about afterwards. In the prospectus, the idea of AMRN marketing Vascepa in the ANCHOR indication by itself is mentioned first and strategic collaboration is mentioned afterwards. Given Astra Zeneca's recently announced acquisition of Omthera, at least one potential partner to AMRN is out of the picture. Our view is that this subtle shift in language is partly an attempt by the company to condition the market for a possible solo launch of Vascepa in the ANCHOR indication. Last fall, when we noticed a subtle change in the 8-K language regarding the New Chemical Entity status (remember those days?), we received some spirited comments about how our reading of the language change was much ado about nothing. Yet, a few months later AMRN ended up launching Vascepa on their own.

     

    AMRN is now trading within the gap in it's chart from 2010. We've been watching the chart for a possible entry, but feel that there may be some further downward movement on a particularly negative trading day for the overall market. We speculatively took on a tiny position in the July $7 calls the week before last when AMRN was trading at $6 and the calls were just $6 per contract. These are likely to be a complete zero (as we've mentioned several times in our weekly reviews, buying front-month options is a particularly risky trading strategy.) Our thinking when buying the calls, aside from the cheap price, was that the July orange book update may lead to another trip to $7. The recent offering has made such a move an extremely remote possibility; however, it is noteworthy that the orange book update has not yet come out and likely will not be issued until next Friday (as we indicated two weeks a
    14 Jul 2013, 11:00 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » OB may be out today -
    15 Jul 2013, 08:46 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (66) | Send Message
     
    a note from CITI today : "Standard 74 day letter appears very clean and appears even cleaner that that received for the MARINE filing. The FDA's Day 74 letter is where the agency communicates any initial filing review issues and preliminary plans to hold a Advisory Comm meeting"
    :)
    15 Jul 2013, 09:38 AM Reply Like
  • sts66
    , contributor
    Comments (1058) | Send Message
     
    Has the 74 day letter been released? How did Citi get a view of it, part of the financing deal or what? In any case, the 74 day letter is essentially, but not identical, the same as the 60 day sNDA acceptance letter. Have some links bookmarked somewhere showing the difference, but it's not much....so a good 60 or 74 day letter is indeed good news, but nobody really expected a problem for ANCHOR anyway. Will be interesting to see if AMRN and/or the FDA brings up this "fish oil/cancer" nonsense at the Adcom, could be a great public stage to put the whole issue to rest, a boon for AMRN.
    15 Jul 2013, 12:11 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » This is old news actually, the "clean" letter was already discussed.
    15 Jul 2013, 04:33 PM Reply Like
  • rml360
    , contributor
    Comments (25) | Send Message
     
    Called IR last week, confirmed total o/s count everything diluted is about 200m, go ahead and laugh, but still predicting b/o at 35 = 7 billion dollar b/o, which includes nce, anchor, marine, and reduce it half done in 2014. I expect b/o will come (as steve agrees) sometime shortly after approval, if not before approval under the following condition: with >90% ADCOM votes for yes (meaning slam dunk). Very possible (still) of early appoval, as I have seen positive adcoms come in, and then shortly approve before pfuda. Also confirmed (unofficially, meaning that Bruno agrees with my info but will not confirm it) with IR about extension of patent whereby FDA will need to decide on NCE Decision in 6 months, which is year end time frame. I hate to reference him, but if you look up biobill (williams) or whatever his name is, you will see that Amarin filed for an extension on one of its patents (not sure which one) however, the USPTO responded to the FDA/Amarin saying they cannot make a decision on the patent until nce is resolved. The clock starts for six months for a response, although not sure when the clock started. I asked Joe B. whether guidance will be given on this in a few weeks (during cc), he said he is not sure. I am sure he will mention it to Joe Z. If I had extra cash right now, would def. p/u a few thousand shares, and flip them after approval.
    good luck to all
    15 Jul 2013, 04:45 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » patents and what goes on at FDA agency and NCE are totally separate and not inter-related.
    15 Jul 2013, 09:39 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » FDA considers patent content to build the science case, but does not rely on it or weigh a patents legal ramifications when making safety and efficacy calls.
    16 Jul 2013, 09:11 AM Reply Like
  • shonjan
    , contributor
    Comment (1) | Send Message
     
    is taking lovaza a risk
    4 Sep 2013, 05:29 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » in some cases, it can be
    30 Sep 2013, 06:12 PM Reply Like
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