I noticed CBS news had a piece on the New England Journal of Med report on triglycerides and ApoC3...lower levels = lower risk of heart attacks.
Good to see it got some traction .
Now hopefully the FDA will reconsider their position ...that TG levels under 500 don't matter .
If they do , this could let to an expanded label and wider approval for Vascepa
Yes they could expand the label , mentioning the new data ...ie lowers ApoC111 etc ..with no mortality stats .
That would seem a sensible comprise ,,,maybe wishful thinking !.
By the way ..I now own the most shares of AMRN I've ever owned . I'm not suggesting anyone buy, sell or hold AMRN...its a very speculative stock ...but at $1.60 a share and this new NEJM information I'm willing to take the plunge
Hi Tod and Mark
Tod ...its a California Cab that goes well with late night reading of the NEJM :)
Mark ---these studies are IMHO very important for us longs as well as for patients . Even Dr Nissen of the Cleveland Clinic ...some one who has always been very skeptical of the benefits of Vascepa and wanted the FDA to wait for Reduce it data before approving the Anchor indication ...even he now acknowledges that this NEJM report "is a big deal " and increases the chances of positive results with the Reduce It trial
But we are a long way from the finish line .ie wider FDA approval for use of Vascepa ...IMHO .
I know one prominent Cardiologist / scientist who has spent most of his career , and a lot of Big Pharm $ trying to find safe ways to raise HDL Cholesterol in the belief this would lower CV risk . To now be told that its Triglycerides that are more important is some what of a "black swan " event for him .
So expect a certain degree of push back from some , with an attitude of wanting to wait for RI data before changing their prescribing habits
Just a quick response
1 ) ...there is always the " method of action " question ..ie does the method by which Vascepa lowers ApoC -111 result in reduced heart attacks...so it has huge marketing impact if RI is successful .
2). This news increases chances Reduce It could be stopped for efficacy before 2016
3) The news increases chances that FDA , Dr Haitt etc may reconsider some form of Anchor approval..or new label allowing more on label scripts , insurance coverage etc ...ie more cash flow to Amarin
Don't expect any quick moves from Amarin on ending the trial.
Well most of you probably don't stay up reading the latest reports in the New England Journal of Medicine .
If you did you would see there is major news breaking tonight about the role that triglyceride levels play in heart disease.
This is important research on the role of the ApoC-111 gene that inhibits the removal of TG's from the blood stream. The lower the ApoC -111 the more Tg that is removed ..the lower the rate of heart attacks .
Amarins Vascepa lowers ApoC - 111 by an additional 20% for those on Statins and by 25% by itself .
Therefore its probably a pretty good bet that 4 gms of Vascepa will actually reduce the rate of heart attacks.
To quote Dr Hegale " Triglycerides are in fact a cause of heart attacks "
Well depending on your time frame
1). You stay long until the FDA responds to the citizen petitions ...maybe within 2-3 months ..and then see if they allow Anchor for at least those with low HDL and high TG's or diabetics
2) you wait to see if the a Reduce It trial is stopped for efficacy in 2015
3) ....you stay long cos you love reading this board ....ok just kidding on 3)
Anyway there's 2 of your 5
I've read your posts in the past so I thought I'd respond.
I'm a cautious long and I also take Vascepa
First the drug ...most patient friendly and effective CV drug I have ever been prescribed ...far better the fibrates or Niacin ...and a deal if you can get it for less then $50 a month with insurance co pays.
Now the stock
By my calculations Amarin has cash to last until early 2016 ...provided they can continue to make minimum payments to BioPharma ( payments based on % of revenue instead of fixed qtly amounts )
So your job is to calculate if RI will show at least 25% benefit by then to allow the DMC to recommend halting the trial for efficacy.
When you are doing that calculation , consider that in RI they are using Statin drugs at up to 4X the strength they used in the Jelis Trial. The secondary high risk group in Jelis is similar but not the same as RI patients
Nothing is a "no brainer " and suggest you diversify , rather then go "all in "
You want me to calculate the P values for Jelis .......thats funny ...for one thing its already been done ...but hey if you can do it and present the full data set and calc's on this message board ...I'll be impressed.
To start you off ... you have 18,000 patients followed for 4.5 yrs with different event rates ...have fun.
Frank a PS
Glad to see you got your TG's down from 520 because as you know ..high TG's with a low HDL is a widely recognized risk factor
Well you must be doing something else ( change of diet / exercise etc ) between March 14 and May 14 to drop your TG's from 194 to 89 in 3 months on 1 gm of Vascepa
Your numbers move around a lot ...Sept 13 LDL at 210 ...6 months later at 95 ...on low dose Statin .....I'll let our biostat expert poster Yourbadhair run a Gaussian distribution analysis for us but I would say that there is a low confidence interval number on the results being related to V ...in other words , if you are familiar with a bell shaped curve distribution ...your results are at the far end ie possible but not common
No one has to calculate the numbers for you ...simply search The Heartdot org Jelis study ...they have a print out for you.
The central pt is " After a mean follow up of 4.6 yrs the addition of EPA to low dose statin resulted in a stat sig 19% reduction in the risk of a major coronary event "
If you question that I suggest you take it up with the biostat people on that trial .
What we want to know is once we have patients on optimal Statin therapy ( most in Jelis were low dose of a lower strength Statin then whats available today ) and add 4 gms of Vascepa ( to that stronger Statin ) ...will we see a 15% RRR with a P value under 0.05 and a confidence interval over 95%.
As you know ..because of the length of the trial and the number in it ...it should be sufficiently powered
Can you provide more detail ...as in complete lipid panel per period and amount of V you were taking ....at least HDL and LDL also
Sept 13 your TG's were 520 ? ....are you diabetic ...and your TG ,s went up from 327 despite 2 gms of V ? ...it's not clear
I for one find Mrmans comments well informed and appreciate his posts
You mentioned Reduce It and the issues to be worried about .....care to expand on that ?
Thanks for the detail
My responses seem to be blocked
I think Yourbad is about to launch into a pitch for dietary supplements
Well my response seems to have been cut off
Look at the Marine Study ....4gms reduced small LDL particle count by 25.6% ( P
Re Statistics ...I have a basic understanding of the meanings of Power , P value ,confidence interval , and hazard ratio..when used in clinical trials ...and can explain them to you without calling you a moron.
FYI for you ...my wife did clinical research at Cornell , graduated from Yale and worked on clinical trials at a major US hospital ...so yes we have had frequent discussions on P values......BUT if you care to enlighten me further , well I'm all ears.
Regarding ...." No . more EPA does not equate to greater improvement " .. you are probably referring to Dr Mozaffarians comments on the Jelis trial ...if you had read further you would have noticed he said " In view of the diverse physiological effects of fish oil and their DIFFERING DOSE-RESPONSE CURVE "...well you can read the rest.
If you simply read the Marine Study ...as an example ...4gms reduced small LDL particle count by 25.6% ( P
Just a quick comment
Using your numbers ....." In this sub group, 158 people taking EPA suffered an event while 197 people NOT taking EPA suffered an event " By my math thats a 19.7% reduction in events on 1.8 gms of EPA between the 2 groups ...please correct my math if necessary.
Given that all the tests to date indicate that 4 gms of EPA lowers all the recognized risk markers more then 1.8 gms ...its reasonable to assume that using this same cohort ...we would see greater improvement ...ie more risk reduction ..if they had been on 4gms instead of 1.8gms
Since I have known coronary plaque deposits ( had a cardiac cath years back ) , family history and diagnosed inherited lipid disorder ( ie I fit the description of the subgroup you identified ) ...I'll keep taking my 4 gms of Vascepa .
Its a risk / benefit decision
You have identified the group that benefited ...I fit that profile ....whats the risk in taking Vascepa ?
Credit goes to Biobill / Williams ....great DD ....as well as imapuddy for details
Apparently the senate has tacked on to the FDA appropriations bill that they ( FDA ) provide an explanation within 60 days for their grounds for revoking SPA's...The senate reminds the FDA that in fairness to sponsors SPA can only be cancelled if there is a new safety or effectiveness issue identified .
Vascepa is safe...AMRN has always maintained that the Anchor indication was for lowering TG's while on Statin therapy .....that's what the SPA was about ....it's safe and effective for that
Whether it actually lowers CV events is what Reduce it will tell us
Interesting pt re CVE benefit in diabetics forcing insurance coverage
Re Gallipoli ( as told to me by my grandfather who was there).
The Turkish forces were well entrenched in heavily fortified position on high ground. They essentially could shell the beach the ANZAC'a were landing on at will. While this battle was going on ...British troops were later landed further up the coast to little resistance . Thus the ANZAC's basically felt they were used to draw the Turkish forces to their beach landing to enable a safer landing for British forces later on ...
Once the ANZAC's had landed and dug in , it was an Aussie commander I believe , under orders to advance by British commanders, that ordered his forces to make a full on charge over open ground against machine gun positions ...as seen in Mel Gibson's Gallipoli.
High command was British ...most of the men on the beach were Aussie, New Zealand and Irish
My grandfather carried a metal kodak camera in his top left pocket ...stopped the bullet that would otherwise have killed him ...passed down form oldest son to oldest son.