I have no problem reading informed opposing views , in fact I seek them out.
However the mis information spread by 1 or a series of shorts who have limited posting histories essentually turn this board into a waste land.
PCSK9's ...are delivered by a sub Q injection and will cost about $1,000 a month . They will be targeted first to those with hetero FH who are statin drug intolerant and dramatically lower LDL cholesterol.
Its a different patient population then the mixed dyslipidemia and very high TG patient that Vascepa is aimed at.
Vascepa is an approved drug . MD's are free to prescribe it "off label " if they choose.
My prescription is off label
Dietary supplement versions of Vascepa are available . They are regulated by the FDA as foods , not as drugs ...quantity and quality of EPA differ . They are however an option for those denied insurance coverage for Vascepa and need EPA.
Those with great insurance coverage can get Vascepa for about $30 a month . The closest DS alternative Omegia Via EPA is about $50-$60 a month
Without insurance but using Amarins coupon , Vascepa cost me $151.72 a month
AZN maintains they do not plan to launch Epanova any time soon . They are under court order to notify Amarin 30 days prior to launch ..at which time Amarin is free to resubmit their claim of patent infringement.
Just the facts as I know them .
Don't care if you are buying or selling . Small cap biotech is high risk . Do not invest more then you can afford to lose.
You may need a subscriptions to read the entire article .
In brief some highlights
1) Two independent large studies in NEJM provide strong evidence for the causal role of APOC3 and TG's in atherosclerosis vascular disease.
2) TG rich lipoproteins seen as a trigger for atherothrombotic events
3) New data indicates causal role fro TG's in increasing CV risk
4) Contrary to common belief ( current AHA guidelines etc ...my addition ) , the current data suggests that we should focus more on TG rich lipoproteins as a target for CV risk reduction
Dr Libby ...Div of Cardiovascular Med Harvard Med School
Vascepa lowers both APOC3 and Triglycerides
Some of you will think this is to pump the stock .
I really don't care
Some of you know me , and know I underwent a Cardiac Cath yesterday as a results of failing an echo stress test last week .
Having been on max dose Statin drugs longer then most alive today ...I can say the Statin drugs work..at least for those with my inherited lipid disorder. After 28 yrs on Statins , I only have roughly a 5% increase in coronary artery plaque...and not enough to require stents .
In the recovery room afterwards I discussed the various CV drugs and trials with my Cath Cardio ...at the end of which he said " I see you are on Vascepa , I want you to stay on it . No risk and likely benefit ".
There you have it ...direct from Cardiac Cath recovery rm.
OT ...for those interested I've commented on the ESPR data released today ..on that message board .
The $15m up front payment may remove risk of dilution pre Interim analysis .
Eddingpharm may market more openly to the Anchor ( TG 200-500 ) patient also .
There are wealthy Chinese who will pay for high quality and safe products ..so there is a market
First the FYI
Merck is running their REVEAL trial ..originally designed to test the idea that raising HDL would lower CV events . This trial is scheduled for an interim data analysis ...at around the end of 2015 ...BEFORE Amarins Reduce It estimated Interim data analysis
Merck disclosed recently in their CC , that they do not believe the data will be good enough to stop their trial at Interim data analysis.
So that leaves Amarins Reduce It as the " Pure Play " on CV trials being stopped at Interim
Second AZN has shown no attempts to date to launch Epanova ...a potential competitor to Vascepa .
Even tho Vascepa scripts are growing slowly , they are nevertheless growing and equally important Amarin is showing they can reduce cash burn thus reducing the likely hood of any dilution in 2015
Third I do not expect Reduce it to be stopped before Interim analysis in 2016...what I do expect is that investment funds like Stonepine will increasingly see AMRN as a low risk speculative play, leading up to 2016
This is a response to satisfied customer1 and info for others interested in these 2 trials .
These are just my opinions ..you are welcome to respectfully share yours .
IMHO Reduce It is NOT the Jelis trial redone in a US population .
The closest part of the Jelis trial to Reduce It , is the Secondary Prevention Analysis group
This analysis concludes with the following " EPA is effective for secondary prevention of CAD , especially in individuals with prior MI.....Satisfied customer ...THATS PRIOR MI
To even qualify for the RI trial you needed to have major CV risks , prior history of stenosis in your coronary arteries , stented , often diabetic as well , family history and so on
The secondary analysis of these patients in Jelis ( the closest to RI ) shows the following
Incidence of nonfatal coronary events ( non fatal MI , stenting , CABG etc ) ..21% lower in the EPA group
The 1,050 patients with prior MI ...The incidence of MCE in the EPA group was 15% , significantly lower then the control group 20% with a P value of .033...ie significant
The 537 patients with prior MI AND coronary intervention...the incidence of MCE in the EPA group was significantly lower (15% EPA/statin group vs 24.7% statin only ) P value = .008 Very significant
Note ...P values tell you how likely the results are to be reproducible if you run the same trial multiple times with new patients , same risk factors . .008 means very high likely hood to see same results
Now there are differences between this Jelis subgroup and Reduce it ...primarily level of LDL to start with and strength of the Statins used ....but thats another Topic Post
IMHO , Amarin is NOT a viable company without Reduce It .....and Reduce it must be stopped for efficacy either before on at Interim analysis for Amarin to have a future.
Amarin will never make it on the Marine ( very high TG 's ) alone
Reduce It costs decline starting around now ...almost fully enrolled , no new sites being set up or marketing to recruit patients ....it's basically on auto data collection ( periodic blood sample and event recording ) now.
No mgt will end this trial so close to an interim analysis data read out
Made up the numbers ?
Read the research yourself
Google...... Circulation Journal 2009
" Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients with Coronary Artery Disease ....Secondary Prevention Analysis from Jelis "
Amarin ..well its late so just a quick glance at your post
No one should be taking Niacin ....risks outweigh rewards
As regards to being a Shill ...Oct I was a soft basher , Nov I'm a shill ?..my story remains the same .
I believe EPA at 4 gms a day reduces CV risk for those most at risk .
I have never been much of a fan of Amarin Mgt ...especially Joe Z.
I also believe AMRN ( and patients ) was screwed by the FDA .
Vascepa should be approved for the Anchor Indication while we await the Reduce It results , solely on a 0 risk / probable reward basis
I really do not care if you buy AMRN stock or short it ...really I do not care
Fantasy , Punk, Brokel, Chen , Tio ....and all the rest of you ( with multiple personalities ) with your one and 2 post histories ......you are writing the same posts you have written multiple times under different ID's
Do you work for HippoMedia / Garden of Living ...spaming message boards to sell dietary supplements ?
Once again , my view on dietary supplement versions of Vascepa .
PlusEpa is a waste of money
Omegia Via EPA offers a slightly lower quality /lower quantity of EPA that will be used by those whose denied insurance coverage for Vascepa .
Those with great insurance coverage will use Vascepa ..Rx quality and lower cost
There are some very angry posters ( or poster ) that show up on this board
Will you please get some EPA
If you have insurance coverage then get the best, Vascepa , if no insurance coverage then at least spend $60 for a month of Omegia Via EPA
Why EPA ... well
1) EPA by itself is the most effective for depression
2) EPA and DHA in equal portions are not benefical for mood and anxiety because DHA "opposes " the EPA
So do us all a favor ...get some EPA and report back in a month
My other posts have been blocked ..so we'll see if this goes thru
Well Chen ...a well written post high lighting the flaws in JELIS
First you state no trial ever showed benefit from Omegia 3's ....suggest you read the GISSI trials ...benefit in secondary prevention I believe.
68% of patients were post menopausal Japanese women already on a high fish diet ..probably one of the highest life expectancies of any group , anywhere . So to see any benefit at all in this group is noteworthy..
I can pretty much assure you that there are no post menopausal Japanese women in Reduce It .
Reduce It is focused on those at high risk of a CV event within 5 yrs of starting the trial
You are correct in your analysis of the Statins . JELIS was mainly low dose simavastatin ...Reduce It is mainly high dose Crestor and Lipitor ...even so , most acknowledge that residual risk remains , despite high dose Statin use .
Over 30% in Reduce It are diabetics ...with a high TG , low HDL lipid ratio . This is the subgroup that showed the most benefit in Jelis and I believe will tilt results to clinical benefit in Reduce It at Interim data.
If we were using the JELIS patient mix in Reduce It ...except adding high dose Statins ....I would agree with your analysis .
Fact is Reduce It is using very different and far more high risk patients .....that's where we will see the benefit
Good to see you back Shortfish as I know you are open to debating a subject
So a little push back from me :)
The Statin used in JELIS was a low dose simavstatin .
Reduce it by contrast is often high dose Crestor or Lipitor ...effectively about 4 times the strength of what was used in JELIS. RI is obviously using higher dose EPA
Simavastain slows atheroscelerosis where as Crestor in particular can reverse it .
The subgroup you mention ....high TG /low HDL did show the most benefit BUT HDL under 40 was not a primarily qualification to get into Reduce It ...LDL under 100 was ....so its not really an apples to apples comparison.
Note Dr Nissen's STRENGTH trial with Epanova requires an HDL under 40.
I'm guessing on a 25% reduction in events ...good enough to stop RI at interim
How many does that cover ? Well there are at least 10m diabetics in the US for starters . All should be prescribed Vascepa if RI interim data is good enough to stop the trial.
Re remaining residual risk .....50% of those who have heart attacks have fairly normal lipid panels ...ie do not have high LDL cholesterol .
So why are they having heart attacks ...likely because of high inflammation ..hs Crp .
Statins lower Hs Crp ( Jupiter trial ) and so does Vascepa ...for those that can not get their hs Crp levels below 2 with Satins alone ...Vascepa is the best add on therapy.
At least 20% of those prescribed Statins give them up in the first year ...mainly because of side effects like muscle cramps . Vascepa offers an alternative for these patients with high hsCrp
Adding insults to your post does nothing but undermine your credibility
Kj4 ..and you other first time bashers
Pick a notary public in the Marina area of San Francisco ....anyone , your choice .
I will sign into my Kaiser health care account in their presence and let them see my lipid panels and I will show them the off label script I have and how much it costs me ....a print out from Walgreens .
I will authorize them to call the pharmacy and chk my cost
There is no way I can fake this ....all you and the other first time bashers need to do is chip in and cover the cost of the notary independently verifying everything for you .
No charge for my time
So you pick a notary , arrange payment for them , tell me who they are ...I'll confirm and then show up .
Mornings work best for me
How do you have so much time to write this ? OMG I've been accused of repeating myself ...get a grip , get a grip ...unless you are paid by the word to write this of course .
In brief Omegia Via EPA is less expensive then Plus Epa .
Vascepa is less expensive then both with good insurance coverage ..and higher quality
Well that post hasn't been deleted so I'll fine tune .
I notice that those with the shortest posting history ...are the angriest . I suspect low blood serum levels of EPA .
So for those of you with very short posting histories ...please ...some EPA
Not an MD ...do your own DD ...but yes anger , anxiety and depression are linked to low EPA levels
9 previous posts so you merit a response
You basically need 240 of the OmegiaVia EPA500 caps to equal 120 of the 1gm Vascepa caps ...probably just a math oversight on your part : )
So you basically spend $60 for a one month supply of Omegia Via EPA ...which is actually a good deal UNLESS you have great insurance coverage like BC/BS , where using Amarins coupon , you can get a months supply of Vascepa for as low as $9 a month ...certainly less then the $60 a month you pay for Omegia Via EPA
It all comes down to insurance coverage .
With no insurance coverage , but using Amarins coupon ...Vascepa costs me $151.72 at Walgreens for 1 month
But if you have great insurance coverage , and need 4gms a day ...you go with Vascepa rather then pay $60 a month for a dietary supplement.
Vpimpins ...see you prove my pts ...this was only your second post and it reeked of anger , anxiety and depression .
Please chk with your MD and see if you can get a script for Vascepa