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Another suggestive alias talking about being diversified within the market. How does me pointing out taking Vascepa for 3 years without bleeding jive with index funds? It's getting so predictable around here. As we near closer to something of news there's always one incessant scribe who just gets pulverized for his merry go round posts. The spotlight is upon you. Get your sunglasses out. The future is bright.
Does anyone know if AMRN has a patent for Vascepa treating DES? The question was recently posed with no response.
The Japanese were the first to develop EPA as a medication. There are many Japanese studies that show its benefits. The problem, as you point out so well, is that the Japanese have a very high EPA level to begin with. To prove the true benefit of EPA on CVD for a western population, with its poor diet, has never been done, at least not in a major way.
Reduce-It results are likely to be far more important than most of us think. The clearer the results, the greater the value Vascepa will have as a CVD drug. Because the study is running longer than many of us thought it would is positive in many ways. I hope it answers the many important quetions so many of us have. "Only" 6 months to less than a year to find out. I bet BP is watching as intently as we are. I also wonder if perhaps a Japanese BP would want to buy AMRN to control the market.
Oh I obviously agree with you. But its funny to see which way the wind blows.
C:.......I've been taking warfarin for sixteen years, Vascepa for four.....been doing my INR, which is a prothrombin time(measuring blood clotting according to international standards), every week.....recently every two weeks.......never noticed any consistent change when I started Vascepa from the time before I started.
yea I do own the stock a lot still. But I want to own more via exercising those options when the pps goes past the strikes higher way higher.
what option strikes you have kiwi? no promise works in stock trading. I don't want to lose this ITC possibility when I played all those worthless ones in the past. may be HDG and BB are correct this time. Gottileb was siding us with our Anchor SPA before he became Commish, may be he gives the green signal for drug makers and enforcement actions on DS cheaters.
Re: EPA intake effect of AA reduction (hence the double effect of Vascepa on both the numerator and denominator of the AA/EPA ratio)
13.2. Anti-Inflammatory Nutrients
The omega-3 fatty acid eicosapentaenoic acid (EPA) will have little direct impact on the reduction of AA because it is a weak inhibitor of the delta 5-desaturase enzyme; however, at high dietary intakes, the EPA can dilute out the concentration of AA in the cell membrane thereby decreasing its potential of being converted into a pro-inflammatory eicosanoids, such as leukotrienes. As stated earlier, high intakes of EPA can also reduce inflammation in the adipose tissue [70–72]. Thus by either directly inhibiting the formation of AA or diluting it out by the presence of high levels of EPA in target cells (especially in the adipose tissue), overall inflammation will be automatically reduced as long there is constant supplementation with fish oils rich in EPA
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952901/
In Jelis the AA/EPA ratio decreases from a an already optimal 1.6 to 0.8 and yet provided a 19% MACE RRR, which was quite astonishing IMO, as you would not expect to see any difference between those already optimal levels. For such healthy population you would not expect a significant difference in deaths between the two arm and as a matter of fact very few died of CDV in this trial and we know that in general Japan has a very low CVD mortality. Why? Because they have a very low AA/EPA ratio!
From various readings it appears that average US citizens have an AA/EPA ratio above 15, 10 -15 times bigger ratio than avg Japanese. It is not astonishing that in USA CVD is the first cause of death by far and that RIT MACE composite rate is almost 10 times bigger than Jelis (4.7% pa vs 0.6% p.a)
RIT was designed to try and achieve (more than double Jelis dosage) a AA/EPA ratio closer to Jelis (also because the more EPA incraseas the more AA reduces as they both compete for the same receptors, so EPA intake has a double effect on numerator and denominator of the AA/EPA ratio) and we know that this is going to make a big difference in terms of CVD mortality and MACE from countless published studies we had in the last few years.
These are the facts, the rest is noise.
By the way ...I have the call options in case HDG is right ...and I'm wrong
Its called hedging
Kiwi
Raf ..having call options has nothing to do with it
a P value of 0.3 ...has EVERYTHING to do with his argument .. Its not Stat sig .. so who cares
Send me arguments supported by a P value of less the .05 ...and then I'll pay attention
Kiwi
Of course you do, you have calls that expire in October.
OK..iwfal...
Gotcha..Interesting...I have not seen those figures probably beccause I did click on that screen...All cause mortality...control arm 265 active arm 286.
Interesting...but not meaningful..And this is the reason its not meaningful..and it is a reiteration of what I said before...
There were a total of 551 deaths in JELIS which was designed as a CVOT trial..but something was pretty strange about the trial. That being there were only 60 deaths directly related to heart disease...35 in the so called sudden coronary death and 25 from Fatal MIs...
You understand of course that CVD is accounting for just over 13% of the deaths in this trial...Looking at stroke we get pretty much a wash helps ischemic strokes hurts hemorrhagic stroke (the guys on anticoags). So what's killing off the the remaining 85%...Maybe all those late nights with the SAKI bottle in all that cigarette smoke...Maybe a bad meal at the FUGU restaurant..we do know gastric carcinoma is a big deal (bigger than CVD???) and maybe EPA doesn't work too well on GC. This is the same kind of thing you might see in a trial for acne cream...if you were foolish enough to be rating the study on "All cause mortality"..This wont translate over to R-I where CVD deaths are going to be way north of 13%...
Nice try though...
?>) JL
Raf ...I agree with your post
265 vs 286 with a P values of 0.333....forget about itttttttt.
Kiwi
Ragman ...agree ...all cause death .
Are U serious ?
Kiwi
Marz ..you promised never to buy call options again ..remember
Don't be sucked in to that siren song if you already own the stock .
Kiwi
I,
All cause death!? Are you serious?
I don't need to remember, I'll just quote you:
"you are ignorant of the fact that Jelis had meaningfully more deaths in the treatment arm"
Lets just stick with facts. 265 vs 286, P = 0.333 Let's repeat...
You: "...meaningfully more deaths"
Fact: P = 0.333
So after I just proved you lying (meaningfully & 0.333), what exactly is your point? Are you trying to say that in RI, significantly more people will die in the Active arm? Then surely the safety committee aren't doing their jobs, because they met probably 22 times to check for SAFETY and every time recommended for the trial to continue.
Figure 3. I'm waiting
"As for Jelis, you mean that trial where the treatment arm had more deaths than the placebo arm? (Did I get that right wink.)"
Nope...Sounds like you are using Pyrr for your source...
JL- I agree... and it pains me to do so.
BB
where were you all these years in the past? why suddenly you want to do good for us? looks like FUDing is in progress, may be you guys are predicting Amarin wins the ITC case. Time for me to buy some cheap call options I guess - I am buying $5 or $7 November or December calls Monday. What the heck throwing some dollars there.
No he won't give you - don't expect the numbers in a meaningful way. But he will tell HRs and Ps and talk in a whole different world that we are not used to. I, North, and your parents and a lot more in our board are the living proof of availing the benefits of V. I don't get scared by their FUDs.
"...Jelis had meaningfully more deaths in the treatment arm"
Facts, please..... Numbers?
ifwal...
Quote...Nope. So... Either:
"A) you are ignorant of the fact that Jelis had meaningfully more deaths in the treatment arm
Or
B) you are dissembling right now to avoid admitting that your favorite trial has some results that imply meaningful risk.
Please admit that you know it has more deaths. Or outright deny it. Either way. You should clarify."
You sound like three year old...I did answer your question. I said the number of deaths in JELIS was roughly the same...That's a quote from AHA..The fact there may have been slightly more deaths in the active arm does not in any way imply meaningful risk..and this is explained in detail in my post..which you apparently choose to ignore.
":>) JL
iwfal...
We get one guy like you every two or three months that comes through here to explain to us what a bunch of knuckle headed dumpster divers we are and how much you have picked up on Biotech Values and the cancer trial boards..Well I have to admit I lack the tasgrewaf experience...Because I am not stupid enough to gamble on cancer stocks...
I guess I'm just biased against..engineers...I should know..SB..Chem E. MIT...I can not think of anything I learned in Chem E that would help me in clinical research...What I have noticed is that MDs try to bring engineering concepts into medicine...I remember a meeting in Manhattan where some doctors were trying to employ fluid dynamics equation into the circulatory system..The problem was they they were assuming blood was a Newtonian fluid which made the whole idea absurd... Engineers and physicists want to apply math including statistics which does not nicely unfold to the situation..You know the rules, but not the exceptions...
A lot of us have been on this board for a long time and stay there because this looks very good...and we have raised and resolved almost all your issues somewhere in the past..I have looked at many, many biotechs in my life and good opportunities are few and far between..I try to stay as current as possible...But Amarin is clearly the best.
":>) JL
Awful, do you mean to say 90% of us using it off label should be experiencing bleeding? I must have rock gut then after taking Vascepa for the last 3+ years.
"As for Jelis, you mean that trial where the treatment arm had more deaths than the placebo arm? (Did I get that right wink.)"
Nope...Sounds like you are using Pyrr for your source...
Yeah, I agree it’s not an issue. Tell that to the iwfal guy who keeps spewing bloody nonsense.
Awful, do you mean to say 90% of us using it off label should be experiencing bleeding? I must have rock gut then after taking Vascepa for the last 3+ years.
FYI....
Postoperative bleeding is the most common serious side effect following face lifts...I operated on over one hundred patients...all of which I placed on Vascepa 4gms/day begining four days pre op and continued them on Vascepa for at least a month post op...None of them developed post op hematomas...
Remember JELIS was a CVD trial and there patients taking oral anticoagulants, and drugs which inhibit platelets...So some bleeding is not surprising...That doesn't mean its a big deal in the general population not on blood thinners..
The latest RWE data bears that out...
Also why don't you look some of your medical terms...epstaxis..nose bleed..sub cutaneous..who cares...
":>) JL
Hi North, thank you for sharing.
1) As you know not only do O3s have the potential to modulate beta cells but there is a growing evidence that Vitamin D may also promote beta cell function. It is rather intriguing that the clinical case report you provided of the Type 1 Diabetic being administered both EPA/DHA Omega 3 but also Vitamin D. Such a single case does warrant a larger clinical study as some critics may just attribute the improvement in beta cell function to Honeymoon Period which is typical in onset soon after the diagnosis of Type 1 DM.
2) The commonest reason for a decrease in Insulin requirements for both Type1 and Type 2 DM is declining GFR. I am confident that with your meticulous care you have been monitoring your eGFR over time. If this is stable, that’s good. If there is a progressive decline, share this fact and the decrease in Insulin requirements with your Endocrinologist.
Another rare but very important etiology for decrease in Insulin requirements in Type 1DM is declining adrenal function and the development of Addison’s Disease which may Co-exist with Type 1 DM as part of an Auto-Immune Polyglandular Syndrome. This is also something that your Endocrinologist can easily check for.
Other more obvious causes of decrease in Insulin requirements include stricter adherence to a healthier diet and increase in exercise regimen.
If the above are all excluded, than your suggestion of potential benefit of V is more valid. Although I have no supportive data to quote by recall, I do believe that benefit of immuno-modulation may be greater the closer the intervention is to the onset of Type 1 DM. I believe that Jay Skyler out of Miami has studied twins with Type 1 DM where the unaffected twin with positive Islet Cell Antibodies became a subject for early drug intervention and study.
3) Finally, while ethically ( and rightly so ) I am unable to advise you of your treatment regimen, you did list two shots of N Insulin as your basal Insulin in addition to a newer analog for mealtimes. I am sure that you are aware that there are newer basal Insulin with less variability, with more stable PK and PD characteristics than N Insulin and with lower risks for hypoglycemia. In my opinion, it may be worth chatting to your Endocrinologist about this as well.
4) Finally, I enjoyed the rodent paper on O3 and the beta cell.
I do think that JT may find your background of great interest and may well reach out to you ! Your attention to detail and care is exemplary.
All the best.??
BC...
Are you serious....This is a biotech...options are part of their paycheck..
Totally means absolutely nothing...
":>) JL
Judge.
Progress continues at the U. of Alabama..in Birmingham on the effects of Verapamil a calcium channel blocker which treats hypertension and arrhythmia.
This may turn the tide for T1 diabetics...T1 diabetes progresses as high blood sugar kills Beta cells (found in the pancreas) which secrete insulin. The hyperglycemic effect involves the action of a protein TXNIP which reqires Calcium for its action which is to trigger apoptosis in the Beta Cells...
Verapamil prevents Ca transfer to TXNIP. This blocks the actions of TXNIP
The original thoughts were Verapamil might be of some benefit in very early stage type ond DMs but would not help if the condition was advanced..Animal studies on going suggest that is not the case and that once apoptosis is halted there may be regeneration and new Beta Cells...
So this could be very good news for T1DMs...
":>) JL
iwfal
Quote: "As for Jelis, you mean that trial where the treatment arm had more deaths than the placebo arm? (Did I get that right wink.)"
Nope...Sounds like you are using Pyrr for your source...
JELIS is complicated and nuanced and requires a lot of study to extract meaningful information...Let me suggest you read post 11548 to begin with.
JELIS seems a large trial by R-I standards more than 18,000 enrollees which is well over twice R-Is...But numbers deceive and as you know its all about events...
The annual CVD event rate for the JELIS trial was 0.8% which yielded only 586 events for the whole five years..That's closer to an acne trial than R-I..Then you have to consider the fact that of the patients in the secondary prevention subset (about 3660).. who are the only group comparable to R-I patients..two thirds of them were there on the basis of a diagnosis of angina pectoris..This is further confounded by the fact the majority of these "angina" patients may have had a variety of angina typical in Western Asia that is not caused by atherosclerosis, but is brought on by vasospasm of sympathetic nerve origin.
Looking at data for the whole JELIS cohort does not provide much insight into R-I...My estimate is less than 20% of the JELIS cohort would qualify for R-I selection..Virtually every JELIS enrollee had better EPA/AA ratios than the every R-I enrollee...And this is reflected in paucity of CVD events and lower annual event rates in JELIS. In the secondary prevention subset of JELIS (about 22% of the cohort) There were more CVD events (355) than there were in the remaining 78% (231)..Still there were only 39 coronary death in the secondary prevention group...21 in the placebo arm..18 in the EPA arm..
It is clear CVD annual event risk was very low in JELIS...The conclusion is if someone dies in JELIS there is a very good chance it was from something other than CVD...Therefore learning that all cause mortality in JELIS was the same in both arms is not surprising. But this doesn't mean that's going to be the case in R-I where CVD will certainly be the majority cause of death,,
Finally...What is really the most important point is that CVD risk is inversely proportional to the EPA/AA ratio. And JELIS confirms this...It was born out by measuring individuals in JELIS..Imagine running an American JELIS...Selecting cohorts adjusted for age, gender, blood chemistries (except EPA/AA ratios) and past medical history..We can say for a fact the annual CVD risk rates in both the primary and secondary prevention groups are going to be at least two percent points higher..than those in the Japanese JELIS...And we know from Japanese coming to America and lowering their EPA/AA ratios that this is not a genetic effect....
":>) JL
Hi Iwfal, Thank you sharing the healthy and important pro vs con perspective.
1) with regard to hemorrhage in Jelis, this has certainly been mentioned at Clinical meetings over the years when Jelis data are reviewed and presented. The mentioned areas of hemorrhage in the Jelis paper include: cerebral, fundal, epistaxis and subcutaneous. It was the first mentioned which caused me reason to pause as it sounded somewhat similar to Statins which we know do decrease ischemic stroke on the one hand and yet have been associated with increasing intra- cerebral hemorrhage on the other.
The paper by Tanaka et al ( Stroke, 2008, 39, 2052-2058) in a Jelis Sub-analysis, observed a significant reduction of recurrent stroke in the the Secondary Population.
Stroke in the Primary Arm 1.3% (-EPA) and 1.5% (+EPA) HR 1.08; CI 0.95-1.22.
Stroke in the Secondary Arm 10.5 % (-EPA) and 6.8% (+EPA) HR 0.80 CI 0.64-0.997. No significant intergroup differences in Cerebral hemorrhage was observed. As R-It resembles more the Secondary population of Jelis, I believe that this is an important paper and point to include in your comments to make it more comprehensive.
It does not diminish your comment about significant observation of hemorrhage with V - I believe that the relevance of this may correspond to what many of us observe in clinical practice, namely subcutaneous manifestations such as bruising - as this is the most common in this category expressed by patients. I am of the opinion that increase in hemorrhage in the V Arm will in all likelihood be reported when R-It is finally published but I think of the more superficial variety while CVE may well show reduction not only in MI but also in Stroke.
2) with regard to mortality decrease, I do agree with you this is a greater hurdle to overcome. However, this is not new in the Lipid space. Statins have been notoriously inconsistent in Mortality benefit. Even the newest PCSK9 inhibitor add on to Statins in Fourier showed only a modest reduction in MACE with mortality leaning on the other side with a HR of 1.05.
You correctly quoted All cause death in Jelis 2.8 vs 3.1% HR 1.09 CI 0.92-1.28.
If one looks at Secondary Prevention in Jelis ( in my opinion somewhat closer to the R-It population) the HR of Coronary Death was 0.87 with a wide CI of 0.46-1.64. At least Coronary Death in Jelis Sec prevention Arm was on the favorable side. I do think that Mortality benefit may be a huge hurdle for V to overcome in R-It. If MACE and several SEs are significant I think that will be of huge clinical benefit without Mortality benefit, as most of us know how challenging such a hurdle is when adding an agent on top of Statins. This may well be more robust than adding Zetia (RRR 8%) or a PCSK9 (RRR 15%) on top of a Statin - and if the RRR exceeds 15%, V certainly will be occupying the value of an add on to Statins never seen before. If the Diabetes subgroup exceeds this, that will capture yet another clinical important clinical indication. Now if Mortality benefit is also observed, well then we all surely will be waking up to Breaking News not only locally but globally.
When I am talking about the RWD, I only refer to it in the context of safety. The DMC meets quarterly on the roughly 8000 RI patients. RWD data is accumulated daily on more then 10 times the number of patients. If there were issues of bleeding, don't you think that would have already been reported to the FDA and the FDA would have acted?
I,
When I am talking about the RWD, I only refer to it in the context of safety. The DMC meets quarterly on the roughly 8000 RI patients. RWD data is accumulated daily on more then 10 times the number of patients. If there were issues of bleeding, don't you think that would have already been reported to the FDA and the FDA would have acted?
Iwdal, why was athralgia the only AE type issue noted from Anchor? If bleeding was an issue why wasn't that mentioned?
Reviewer Comment: There is no definitive answer as to whether omega-3 FA increases the risk for bleeding. Regulatory recommendations with Vascepa and concomitant anticoagulants should convey caution.
Anticoagulants
Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
A tiny, single arm, study was never going to tell them anything unless the patients were dropping like flies.
Your turn
What do you think of the unblinded RWD trial of now 100,000 plus that AMRN is running?
Iwdal, why was athralgia the only AE type issue noted from Anchor? If bleeding was an issue why wasn't that mentioned? Keep trying though.
I'll cite this:
http://www.americanjournalofsurgery.com/article/S0002-9610(16)30462-7/pdf
These kids were being given fish oil via IV. Near as I can tell, typical dose is 1 gm/kg/day. No surgical bleeding complications.
Your turn.
Bio,
I believe this was a pre-planned sale. Maybe when the sale was planned, he thought there could be a possibility of a stop at 80% amd was hoping the price would be $20/share. If the thinking was this is a failure, he would have planned a much larger sale.
I,
What do you think of the unblinded RWD trial of now 100,000 plus that AMRN is running? If there is no reports of bleeding thus far, I put the probability of that being an issue at close to zero.
"Even without the below, there is plenty of reason to think there is likely an issue "
??? 'Reason'
Cite it
Martek Biosciences was bought by Royal DSM NV, but they do not make EPA products, only Omega-3 DHA and Omega-6 ARA, and yup, ARA = Arachidonic acid - bad for adults, but apparently essential for infants. DHA is algal based, ARA is plant based fungus (I know, ick!).
"Plenty of reason"? Cite it.
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