Re " explain why the FDA or AHA etc ...see's no clinical benefit in lowering TG's
I'll take a stab at that
1) FDA wants an Outcome trial to show benefit . They had approved drugs like Niacin , Fibrates etc in the past that now , after several Outcome trials show little or no benefit for most patients .
( there was benefit in the high TG and low HDL sub groups )
So they are now a lot more cautious on drugs that lower risk markers other then LDL
The AHA is using older trials to support their cautious position ...and have become more evidence based US centric ....eg a clinical trial using EPA in Japan may show great results , but it's largely ignored here until we see same results in a US population
I can argue both sides
Vascepa is best in class for the 200-500 TG range .....but many MD's will not treat TG's under 500 beyond changes in diet and exercise
For the over 500 TG's ...if Pancreatitis is a serious concern , Lovaza ( generic or otherwise ) is considered more effective especially if the patients LDL is under 100 on optimal Statin dose.
Over 500 TG's , the concern is Pancreatitis ...less so CV disease.....for many patients
The gold mine for AMRN is evidence of reduction in CV events ....that's why we need Reduce It results ...and we need those results before they run out of cash
Well you have been with us for almost 30 days according to your posting history so I'll respond .
I applied to be in the Reduce It trial , was interviewed by them and exchanged several emails
Should you doubt this , please select and pay for a Notary in SF and I will meet with them and they can access and verify my email records for you.
I am a firm believer in EPA's ability at 4 gm doses , to lower cardiovascular events for those at risk ...( ie those with family history , prior MI , diabetics and those on dialysis ) .
I 'm just not a fan of AMRN's past management OR the FDA's new attitude preventing patients using safe drugs while we wait for Outcome data
Anchor should be approved , at least for high risk patients
That " reach a position that is cash flow positive " comment ....I'll file that with my " not a dollar under $30 " and " the next 90 days will be exciting " collection
IMHO ...no one is interested in this company until and if , Reduce It shows clinical benefit .
Look at their current debt load and cash burn
Their back will truly be up against the wall by mid 2015 unless KOWA pulls off the ultimate Hale Mary throw and significantly ups scripts OR by some miracle the FDA expands the approved labeling.
Just the pt of view of someone that has met payroll and debt payments the last 30 yrs
Always appreciated your posts
My perspective ( as an exCEO of a small Corporation ) ...This company is almost toast , unless positive Reduce It results come in before the Co runs out of cash ( which by my calc's may be last half of 2015 )...OR unless the FDA allows some degree of expanded label. Eg for diabetics
Let us remember the days of " not a dollar under $30 a share " or " the next 90 days will be exciting " thanks to our previous CEO . Combine that with and FDA that now wants to make thousands of " at risk " heart patients WAIT for results on a very safe drug before allowing on label scrips .....and you get a company and it's stock holders hanging by a thread .
That thread by the way is the Reduce It trial ......the only thing that saves this co IMHO is early and positive Reduce It results
By the way...I take Vascepa and still own some AMRN stock
In the interest of full disclosure
My wife works in dialysis at a major hospital
She and the MD's she works with are fed up with fighting with insurance companies for the drugs their patients need .
To quote " We recognize the benefits of " fish oils " and in particular this study using EPA , HOWEVER its just easier for us to recommend dietary supplement alternatives then to spend our limited time fighting with insurance companies for coverage "
So the challenge for Amarin is to not only educate MD's that Vascepa is different ( and superior ) then DS
alternatives , but to also persuade Insurance co's to cover .
By the way ..I take Vascepa
Just to get your attention as my earlier post is probably buried in your thread
European Heart Journal 2013
Eicosapentaenoic acid restrains the development of cardiovascular events ........etc ...in Japanese hemodialysis patients
Conclusion ...EPA significantly contributes to decline in risk of cardiovascular morbidity and mortality in HD patients etc
My own view is that its more about EPA's effect on the EPA /AA ratio , lowering inflammation , stabilizing vulnerable plaques etc then simply lowering TG's.
The " failure " ( if I can use that term ) in Jelis is that Jelis studied a population that was to healthy .
They didn't make that mistake designing Reduce It ... ( not comment earlier in your thread )
A few comments on your post .
I agree that there are some problems with Jelis , primarily that it was an open label study using only 1.8 gms of EPA and about 2/3rds of the participants were postmenopausal
Japanese women ( known for high life expectancy and low CHD ).
The Reduce It trial is quite different . High risk patients only using 4 gms of EPA ( Vascepa ) ...
You need several of the following to even apply for the trial .... a history of CV events , stenosis of 2 coronary arteries ( now with stents ), diabetic , multiple risk factors ( family history etc ) and so on ...plus still have TG's over 200 after having got your LDL cholesterol under 100 on optimal statin therapy..
The participants in the trial are mainly US citizens but many are also from Eastern Europe where as many as 40% of the males have a CV events by age 50
Reduce It is NOT looking at people with no history of heart disease ....they want patients with a known history of CV events who are expected to have a major if not fatal event within the next 5 yrs
Sorry I can't link the following but suggest you read
Cardiovascular Drug therapy Feb 2014 ..Eicosapentaenoic Acid combined with optimal statin therapy ...etc
Circulation 2011 High Purity Eicosapentaenoic Acid in addition to a strong Statin ..etc
Atherosclerosis 2014 May Stabilizing effect of combined eicosapentaenoic acid and stain therapy etc
Gun ....again with the dietary supplement BS
Oh where to start ?
If you can get Vascepa with great insurance coverage for $9 a month ...why are you going to bother with Omegia Via ( left in you driveway via UPS ) for about $30 plus a month
I've tried them all ...PluseEpa , Omegia Via , Vascepa .with blood tests ..I email in the blood test request ,
It costs me nothing every 6 mths ( Obama Care Kaiser ) ...Enough already
I can make a case for using supplements far better then you can ....it's all about insurance coverage of Rx , quality of DS product and delivery of said product ....come on ..step it up
A quick follow up .
The trial you cited used 2mgs of Pitavastatin ( Statin ) with 1800 mg of EPA
The new trial is using 4gms of the statin with the 1800 mg EPA ....and hopefully this will help answer the question ..." If you maximize the Statin dose ,will you still see additional improvement in the cohort getting the EPA in addition to the Statin." ...... if we do ,that would be big news because if we see improvement with 1.8 gms of EPA , we should see even more with 4gms of EPA
To qualify for the Reduce It trial they require you to maximize your statin dose until your LDL is under 100
I could never get my LDL that low on max dose Lipitor , never mind 2 gms of Pitavastatins.....so this new trial with 4gms of Pitavastatin will be a closer to Reduce It.
I just wish they were using 4 gms of EPA , not 1.8 gms
Pitavastatin is made by Kowa Pharm ...who have just signed the co marketing agreement with AMRN ...so you can see where they could be going with this ...Kowa has an approved Statin for the US market , Amarin has an approved EPA for the US market ( Epadel ...1.8 gms ..is not approved for the US market )
Beyond the script data . possible FDA approval for diabetics etc ..IMHO its all about potential for proof of benefit in lowering Cardio Vascular events .
To get some idea on that I will be trying to follow the CHERRY study in Japan .. Google " Combination therapy of eicosapentaenoic acid and pitavastatin ...etc .. They are only using 1800 mg of EPA with a Statin ( like in JELIS ) and will looking for regression of coronary plaques , plaque volume , inflammation etc and will be following these high risk patients for 6-8 months ....this info comes from Zumantu on IHUB by the way.
If those getting the EPA plus Statin show a stat sig benefit vs those only on the Statin ....that will greatly increase the chances of Reduce It showing reduction in CV events .
They announced the trial in Feb 2014 ...don't know how many they have recruited etc . or if they have optimized satin therapy ( ie strongest dose to get LDL under 100 ) ...if you can find out please let me know but this trial looks like a mini Reduce It Trial...and if Reduce IT shows CVE benefit then you'll remember the day you could have bt AMRN for $1.65.
In other words ...those who follow the science will be watching the CHERRY trial as to whether to add or dispose of positions
I'm still here and will be as long as the Reduce It trial continues .
I will stay in AMRN until at least the Interim Data analysis , which I hope will be disclosed to us by late 2015
The P value in the sub group analysis was .043 ...of course you will know what that means right.
AMRN is a highly speculative position ...IMHO its a race between cash burn and hopefully a very +ve interim analysis .
I don't mind if you are short ..just prefer you attempt to write reasonably informed posts to support your position.
Carnegie ...for some reason I have you blocked
To your question ...Its on Pub Med ..I'm quoting from the abstract " EPA treatment suppressed the risk of CAD by 53% ( HR :0.47;95%CI: 0.23-0.98; P=0.043 ) "
Just relaying what the Atherosclerosis article published ...if you have a question about their numbers , suggest you take it up with them .
Great post . Appreciate the detail
Would love to see an interim analysis by late 2015 ...Amarin can hang in there ( no dilution hopefully ) until then
Brian ...missed this early post before but will now comment.
You are completely wrong .
CV events are caused by multiple factors ...50% of those that have CV events have normal cholesterol levels ...read that again.
Multiple studies link low serum EPA /AA levels to CV events ...especially those in 1st yr of dialysis
Re investing ...I have a small speculative long position .I take the drug ( Vascepa ) , I don't think much of past management BUT I think the Adcom committee made an awful decision not to expand approval pending interim analysis.
On a risk /reward basis ...IMHO anyone with CV risk factors , diabetics , dialysis patients , family history , mixed dyslipidemea , FH etc ...should have Vascepa ...there almost no risk from taking it .