Agree you can always come back ....that what I told myself after selling TSLA at around $130 ...I was up over 60% ...don't get greedy I said to myself ..I can always come back when they sort out this fire issue ...oh yeah
I think theres a chance the FDA may find away to expand approval for those at high risk .....simply looking at a risk/ reward analysis ..it would be hard to explain to a diabetic age over 65 with prior history of an MI or currently with stents ..that Vascepa had 0 value . There are just to many research docs out there to show other wise.
I will not be selling as long as the company continues Reduce IT
I agree that there are some great opportunities out there .
I have 50X more in FBIOX , larger positions in ILMN , ARWR, TKMR etc ...I'm in AMRN because I take Vascepa and have a family history of heart attacks.
I would just leave you with one question ...."Name one drug that can be taken with Statins ( other then maybe low dose asprin ) that is proven to reduce the risk of heart attacks ".....name one that is clinically proven ( double blinded trial ) to reduce CVE ( Cardio vascular events ) in a US population on Statin therapy.
What would that drug be worth ?
Good to see you posting again
We have exchanged views on AMRN going back to late 2012 I believe ...where I was saying that I did not understand their process to tier 2 coverage and I did not think a sale was imminent ...thus I was reducing my position.
My view now ...AMRN should have cash to make it to Reduce it interim data...late 2015 / early 2016 ..and IMHO thats all that matters .
We either have a drug that lowers risk of a heart attack in a US population or we don't ...plain and simple.
I'm betting we do ...and by the way I have lived longer then any male on my fathers side going back 3 generations ( all died of heart attacks ..inherited lipid disorders ) and I'm currently on max dose Crestor , max dose Zetia and max dose Vascepa
Tod ..good to hear that you have made up your loss's on other biotechs .
Remember folks ..the ONLY free lunch is DIVERSIFICATION ..no matter how much you love a particular story or drug .
Knife ..I'm only going to waste a small amount of my time correcting you.
Hetero familia hypercholestremia is 1 in about every 450 people in the US . Mixed dyslipidemia in the US is about 24 m people ...these aren't rare conditions .
We will have some indication before 2017 whether Vascepa is working or not to reduce CV events ...Interim data analysis will probably be late 2015 /early 2016.
Lets see ...how much DHA is in my muliti grain breakfast cereal ? ---Nah , why bother
To start a new thread ...a brief note
Mozaffarian ...Medscape 2007 " although the trial ( Jelis ) was open label and such soft end points as Angina ........these results SHOULD NOT be discounted " ( my emphasis )
Since 2007 there has been more research in the field of EPA
Atherosclerosis 2013 Dec 23 " Association between ratio of serum eicosapentaenoic acid to arachidonic acid ....
If you such thru Pub Med or the various journals ( Circulation , Atheroseclerosis etc ) you will find more studies since Jelis that indicates likely benefit of taking 4 gms of EPA daily for those who patients "at risk " ..diabetics , those starting dialysis , those with high TG/low HDL despite max Statin dose etc ...especially those who have had a heart attack or have required Stents
The Reduce It trial is targeted to show clinical benefit for these patients ...to reduce the risk markers whereStatin treatment alone is not very effective ( Stains are not very effective at lowering high TG's for instance ) and Stains do NOTHING for improving your EPA/AA ratio
As Mozaffarian stated .. the Jelis results SHOULD NOT be discounted . Reduce it builds on the Jelis trial ..it is NOT a copy of that trial
I'm a nice guy ? ...Hey its all that EPA I've been taking ...it mellows me out. : )
My wife re Lovaza /Vascepa ---her fight is with the hospitals Pharmacy ....Lovaza is firmly entrenched ( GSK did a great job ) so pharmacy does not have Vascepa in their formulary and insurance coverage is difficult.
Re Lawsuits ...Nuke in 20 yrs as a CEO I signed over 400 contracts ...8 ended up in court ( six I was plantiff, two defendant ) .. My goal in life is never to see the inside of a court room again or pay an attorney again ... my sense is that Kennedy ( the attorney ) has basically created a job for himself ...consider me jaded ( as I am )
Re Butters comments ...the guy ? must be in medicine . I would just pt out that the ideal person for the Reduce It trial ( based on my emails with the Co running the trial ) is a diabetic male over 65 with previous MI or with stents , with metabolic syndrome ( fat gut ) and still has TG's over 200 despite getting his LDL down to 100 on Stain therapy
Reduce it is NOT Jelis part 2 IMHO
GL Nuke ...and thank you Home builder for the scrip updates
From what I have read ..the high dietary EPA added on average 1 gm of EPA per day ...so total EPA was 2.8 gms for the Japanese cohort
Not many think that 2.8 gms of EPA will do much for the average healthy postmenopausal US woman with moderately elevated LDL ( closest comparison to Jelis cohort )..beyond what was seen in Jelis.
What they do think ( Drs Bhatt, Ballantyne et al ) ...is that if you give 4 gms of EPA ( Vascepa ) to a cohort who are the following
Optimised to statin therapy ...LDL down to 100
TG's ...now required to be over 200
Previous history of heart attacks or 50% stenosis of 2 coronary arteries
Diabetic with family history of heart attacks
More male then female and average age about 65
As well as other risk markers ...low HDL/high TG etc
You will see clinical benefit because the EPA will reduce the residual risk not treated by Statin therapy.
Previous history of heart attacks ...or now with 2 stents ...is a major qualifying factor .
They interviewed me ..my take is that they were trying to recruit those with a life expectancy of about 5yrs ..or at least ,expected to have an event within the next 5 yrs.
Reduce It is a high risk group . Jelis was not ...big difference ( as well as dose level )
Mark ...he is correct in that it is debated
See "Jelis published : Fish oil added to statin therapy reduces risk of major coronary events ".. The heart dot org ....19% reduction in risk of major coronary events
Her ( Beatrice ..Hawaii ) comments were about the benefits of using 1.8gms of Epadel in a US population that are not huge fish eaters .....so yes 1.8 gm is not likely to have much effect .
Which is why Reduce IT being run with 4 gms of EPA ( Vascepa ) because Dr Bhatt and those with him running this trial have determined that this level of dose with the high risk patients in the trial ...diabetics, previous heart attacks etc ...is where they believe they will see clinical benefit .
Reduce it is NOT being run using only 1.8gms of EPA on mainly fairly healthy postmenopausal women with moderately high LDL ( as in JELIS )
I plan on keeping my shares to at least interim data release or to when Goldman Sachs takes over the trial ..which ever comes first : )
While I agree that Jelis is debated by physicians ( in my experience primarily around the fact that most benefit was seen in fewer reports of Angina rather then "hard " evidence like MI's and 68% of the cohort being postmenopausal women ).....there have been more recent studies have pointed to likely benefit from EPA
Atherosclerosis 2013 " Association between ratio of serum eicosapentaenoic acid to arachidonic acid and risk of cardiovascular disease " as an example ....
If you go thru PubMed , Atherosclerosis , Circulation etc ..you will find several RECENT ( within past yr or 2 ) studies showing high probability of benefit for at least certain sub groups ..diabetics , those with low HDL / high TG , low EPA serum blood levels etc
From a risk / benefit analysis IMHO ..all of the subgroups mentioned above should have affordable access to Vascepa while we await at least the interim data analysis.
Amarin probably has enough funds to make it to interim data analysis ( late 2015/early 2016 ). If there is no sign of clinical benefit then ..there is probably little point in continuing to fund the trial.
They will continue the trial anyway until they exhaust the FDA appeal process ...that may take at least 6 mths
Amarin doesn't need your donation ( nice of you to offer ) ...they need to explore alternatives with Goldman Sachs ( there's a reason Goldman was on the call asking about Reduce it )
Feedback from my wife ( who has prescribed both Lovaza and Vascepa ) is that some MD's may be reluctant to renew scrips for off label use since the -ve Adcom vote and there may be more push back from insurance co's
Agree Benny ...The one question from the Goldman Sachs analyst ..." Whats your plan with Reduce It "---Goldman knows where the real $ is ....Reduce it showing clinical benefit
I don't believe I ever stated my insurance carrier covers Vascepa . I mentioned the coverage I believe poster Nuke has and I think poster Mark gets a better deal .
Currently my insurance carrier does not cover Vascepa .
I pay $132.32c for it at Walgreens using Amarins coupon plan
If you can provide me with an email address I'll email a you a photo of the prescription sheet ( with my last name blocked out ) . The doc will show where I live which is in Mill Valley Ca
As regards my story ....I have met people from this Amarin board and Ihub Amarin board on the plaza in Mill Valley for coffee in the past I'll extend to you the same offer ( and anyone else whose is in town ). I always offer to present my lipid panel results ..they go back as far as 1985
If you review my posts you will find that I'm very supportive of the drug but NOT of the management.
Nor have I always been long AMRN , in fact I was out of AMRN from late 2012 to mid 2013
I'll post a comment on your Jelis comment later when I have more time
My TG's were 210 and I got a script for Vascepa
I am required by my Cardiologist to keep my TG's below 135 because my HDL is under 40 and a family history of inherited lipid disorders and early heart attacks .
Which FDA approved drug to you think does that ....get my TG's down to 135 without raising my LDL ?
Freedom ..the problem with posts like your ( and others trying to sell supplements ) is that they post false information .
This is unfortunate because high quality EPA supplements provide an option for those with cardio vascular disease but who can not get insurance coverage for Vascepa or can't afford it even with the Amarin coupon
You would do your business a great favor if you were to post ACCURATE information ...other wise you'll just be IGGY'D
They expect a cash burn of ( hopefully ) $80m in 2014 ...if they manage the same in 2015 , how long does their $191.5m in cash last them ?
Well hopefully until we get an interim data read out on Reduce It ..early 2016.
IMHO the value ( what there is ) is in Reduce It showing clinical benefit..... no one can claim this is the best drug ( Harvey ) until you see proof of clinical benefit in a double blinded trial with mostly US citizens.
The FDA appears not to be interested in how good a drug lowers surrogate risk markers other then LDL
So my take is that Goldman and the others on the call have read Atherosclerosis Dec 2013 " Association between ratio of serum eicosapentaenoic acid to arachidonic acid and the risk of cardiovascular disease " and Atherosclerosis J. " Suppressive effect of EPA on the incidence of coronary events " and are figuring out the probability of seeing clinical benefit in Reduce It and what that would be worth to whoever owned Amarin when and if that happens
They aren't on the call to find out about Marine sales
I would caution you against heavily investing in AMRN . IMHO this company will disappear if they drop the Reduce It trial or fail to make it to interim analysis ( my guess in about 2 yrs )
I agree with Baker364202 ( who writes some of the most informed posts here ---thanks Baker ) that the trial will likely show clinical benefit ....reduction in CV events .....but we have to make it from here to there.
Surviving on Marine sales ( very high TG's ) alone will be difficult as Lovaza is firmly intrenched and will likely be generic in 2015 , making it more difficult to get insurance co pays for Vascepa .
Full disclosure ...I take Vascepa , I think its a great drug . However as an investor I'm risk adverse , widely diversified and have less then 4% of my portfolio in AMRN.
I may increase that position if I'm assured that Reduce it will continue to at least Interim data release.