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Gary Head

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  • Basket Of Biotech Bargains To Buy And Hold [View article]
    Intrepid
    A reply to your reply
    The investment potential for AMRN is not in capturing the very high TG market ( TG's over 500 ) ...IMHO ...its in gaining wider approval for those with Cardiovascular risk with TG's between 200-500.

    Name 1 drug other then Statins that has been proven to lower CV events in an Outcome trial. So forget Fibrates ( Accord trial ) Niacin ( Thrive trial ) and regular fish oils or Lovaza.

    Even looking at Statins ...look at the Jupiter trial with Crestor ...that trial was more about lowering hsCRP ( inflammation ) then about lowering LDL.
    Vascepa lowers hs CRP by about 22% ( going from memory ) as well as lowering TG's and also slightly lowers LDL .....so its lowering multiple surrogate risk markers associated with CV risk

    The long term question for AMRN is whether or not they can get a positive read out on their current Reduce It outcome trial before they run out of cash ...note Biwatch's article in SA.
    Note ...even Dr Nissen ( Cleveland Clinic ) has been quoted as saying that the recent NEJM reports on APOC3 and TG's increases the chances of success for Reduce It
    In the short term the FDA has to respond to numerous Citizen Petitions protesting the AMRN adcom hearing and the rescinding of AMRN's SPA.
    Gary
    PS ...nice wave you are dropping into ..profile photo ...go big or go home :)
    PPS ...Vascepa is the easiest ( patient friendly ) lipid altering drug I've ever taken ...and I've taken them all except Lovaza , usually at max dose ( hetero FH )
    Jul 1 12:36 PM | 1 Like Like |Link to Comment
  • Amarin Scrapes The Bottom Of The Barrel [View article]
    Right Louielouie

    Commenting on this new research

    " Based on our findings , we predict that lowering TG's specifically through the inhibition of APOC3 would have a beneficial effect by lowering disease risk "...Prof Reiner .
    Similar comments from Dr Kathiresan

    Commenting on the studies
    " very strong type of evidence that TG's are in fact a cause of heart attacks "-Dr Hegele.

    Even Dr Nissen ..Cleveland Clinic has been quoted as saying that this research increases the chance of a successful outcome for the Reduce it trial

    If the event lines in Amarins Reduce It trial diverge by at least 25% ...showing clinical benefit from 4gms of vascepa ...over the next year 18 months ...chances are Reduce it will be stopped for efficacy well before 2017.

    The recent NEJM research you cited , increases the chances of that happening.
    Gary
    Jun 27 11:29 AM | 5 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    Ralph
    Altho we are both long , I can also argue the bear case

    When comparing to Jelis ....you are referring to the subgroup that had high TG's as well as low HDL cholesterol ...not simply high TG's

    Second ...The Statins used in Jelis were low dose of medium strength Statins . Many in Reduce It will be on Crestor of Lipitor at doses that may be at least 4 times the strength of what they were taking in Jelis

    The average LDL cholesterol level in Jelis was I think at 177 ...to qualify for Reduce it you have to get your LDL below 100

    Gary
    Jun 12 01:15 PM | Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    RHM
    AMRN is not dead until Reduce It fails .
    Name one other drug added to Statin treatment thats proven to reduce CV events in a US population .
    If Vascepa does it will be the first that I know of .
    Gary
    Jun 12 01:08 PM | 4 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    Big Alpha
    IMHO at roughly $1.60 a share you are buying an option on an early positive read out on the Reduce It trial .
    No one is interested in waiting to 2017 for completion of this trial ...we want it stopped for efficacy well before then ...in fact before the end of the 1st Qt 2016 ..when I estimate that will have burn't thru their cash on hand.

    As long as the Bio Pharma deal allows them to pay on a % of revenue instead of a fixed qtly amount , and KOWA provides some lift in sales by year end ( so they don't actually loose $ on their sales force ) they can make it to early 2016.

    So the real question then is ...What are the chances of Reduce It being stopped before they run out of $.
    For those interested I recommend the Seeking Alpha article by Biwatch.
    Gary
    Jun 12 11:09 AM | 3 Likes Like |Link to Comment
  • Amarin Is Likely Now A Vortex Where Your Money Will Go To Die [View article]
    Quoth
    I would be interested in your view of the SA article written by Biwatch Dec16 2013
    " Amarin Todays market is underestimating the probable success of Reduce It "

    Reduce It interim data analysis is likely early 2016 . As long as Amarin keeps Reduce it going and doesn't burn through their cash until then , its a little premature to concede defeat
    Gary
    Feb 26 02:40 PM | 5 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    Quoth
    The smart money is betting that the FDA will expand the label to include at least those with a combination of high TG's and low HDL despite Statin therapy .
    Suggest you read the Clinician /Scientist SA article on it posted earlier and visit the EPAdruginitiative site
    Gary
    Dec 20 11:26 AM | 4 Likes Like |Link to Comment
  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    Biwatch
    Thanks for the article on Reduce it .
    Lets hope they can fund it to at least interim data.
    Gary
    Dec 16 04:46 PM | 1 Like Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Futuristics
    From memory ...Vascepa is DEVOID of DHA , Epadel has about 2% DHA ...thus Amarin was able to patent AMR101 ( Vascepa )

    As a side pt ...The real value for Vascepa may be its ability to lower inflammation ( hs CRP ) and improve the EPA/AA ratio.

    Suggest you read Eicosapentaenoic Acid ( EPA ) Reduces Cardiovascular Events etc Journal of Atherosclerosis and Thrombosis Sept 18 2013.
    Dec 2 03:02 PM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Futuristics
    Regarding the Trial examples the FDA cited
    ACCORD ...median TG level was 162
    AIM HIGH - only 12.8% of patients had TG's over 200
    HPS2-THRIVE -- median TG level was 125

    Bit of a leap , don't you think , for the FDA to make a blanket statement that lowering high TG's ( 200 - 500) doesn't matter ..based on these 3 trials .
    None of them were specifically designed to examine the benefit of lowering TG's in patients where the median level was over 200 and particularly in those that had an HDL below 40 with a TG level over 200 , despite optimal Statin therapy.

    Vascepa is a very safe drug and should be easily available for all "at risk "....while we wait for the Reduce it data
    Gary
    Dec 2 12:22 PM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Futuristics
    I support anyone taking the time to write an article BUT I would appreciate it if you could at least try to present factual information.
    I'm sure if you went back over this you could improve it.
    Example ... The Jelis Study used 1.8gm of Epadel ( you stated 1 gm )
    Maybe read some of the comments above and work a little harder on being factual next time
    Gary
    Dec 1 04:17 PM | 3 Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Chenz
    Many , if not most , in the Reduce it Trial have already had one heart attack , severe Angina or coronary arteries blocked enough that they required stents ...in addition average age I think is now about 65 and many are diabetics
    You might be surprised how many "get religion " re diet and exercise after spending a couple of hours on an operating table.

    Reduce it is a well designed double blinded trial and IMHO we should know within 2 yrs whether 4 gms of Vascepa daily makes a difference or not ,once patients are on optimal Statin therapy.
    AHA and the no votes in Adcom seem to believe its all about optimal Statin therapy and nothing else ....despite all the recent research on the benefits of high doses of EPA
    Gary
    Dec 1 03:59 PM | 1 Like Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Chez
    A real possibility is something similar to what happened with Crestor in the Jupiter trial
    In that trial the Data Monitoring committee stepped in , about 2 yrs into the trial .
    They deemed the event lines had diverged enough to halt the trial on the basis of efficacy and Crestor went on to become block buster drug it is today.
    If something similar were to happen with Vascepa , it should happen by the end of 2015.
    Gary
    Dec 1 12:33 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    PSalerno
    I think Epanova looses out to generic Lovaza .
    I didn't see any CRP ( inflammation ) data on Epanova ...did you .?
    One area I agree with you on ...the true benefits of Satins may be that they lower inflammation ...and by the way Vascepa is pretty good at that also.
    Gary
    Nov 20 04:36 PM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    PSalerno
    Re " Statins showed a reduction in CVE later anyway "
    Yes but at the time we were first prescribed them ..it was solely on the basis of reduction in risk markers .
    Should doctors have waited on Outcome data before prescribing Statins ??

    As a patient I have no problem taking a safe drug that reduces my risk markers while I await Outcome trial data ....its informed consent .
    The FDA can simply say that Vascepa is safe and may benefit some at high risk ....but that its true clinical benefit , if any ,won't be known until the Outcome data is published.

    By the way ..I didn't find it easy to get an off label prescription . Some MD's do not like to prescribe off label
    Gary
    Nov 20 04:21 PM | 1 Like Like |Link to Comment
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