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Hi JL, based on this I'm wondering if I should be concerned that the 4g/day I'm currently taking of Vascepa is the right dose? I also eat fish a couple days each week and use a small amount of fish oil in my daily protein shakes. Basic question I guess is how much EPA is too much?
UFO
This idea has been around for a very long time summarized by the saying ...anything is a poison .... in a high enough dose
We use to lose one or two people a year in this country in water drinking contests ...
EPA...
Some of my recent posts may be difficult to follow because I was going through new material regarding all cause mortality...Let me try to clarify the issue of how EPA effects CVD and other conditions...
The EPA/AA ratio has a very important influence on systemic inflammation. Increasing the EPA/AA ratio lowers the sensitivity of the inflammatory system to perceived threats. Degenerative diseases such as atherosclerosis probably result primarily through mistakes made by an over aggressive inflammatory system which attacks the host tissues. Unlike acute attacks. such as most bacterial infections, degenerative effects are chronic and largely asymptomatic. These have been long considered just part of the aging process..
Since increasing the EPA/AA ratio lowers systemic inflammation and lowers the event risk in degenerative diseases...read CVD. It is plausible and probable that lowering the inflammatory shield promotes conditions in which the body is being attacked by outside agents; and it is known increasing the EPA/AA lowers platelet adhesion and this could increase the risk for bleeding...These effects would not be noticeable or even measurable, on an individual basis but could be seen on a population screen..
The important thing is there is probably an optimal level for the EPA/AA level...One that stifles degenerative diseases, but does not raise acute risks...This mean that EPA is probably good up to certain doses after which it could it might have the potential to raise over all risk...Knocks out CVD but increases infections...
I do not think this will be an issue in R-I because CVD is such a huge target and the doses should get the ratio up to Japanese levels...Looking at the mortality rates for the ten leading causes of death in Japan...comparing them to the USA rates...The death rates beginning with CAD the USA rates are much higher than the Japanese....This is clearly the result of higher EPA intake in Japan...and will be reflected by great results in R-I which moves us closer to Japanese levels.
":>) JL
This could be huge for the KOWA deal...No?
ORBAPU,
I read a more in depth article a month or so ago. I believe you have to include China trial sites in your study to qualify for quicker approvals. I don't think AMRN did this for RI.
China to accept data from overseas clinical trials to speed up drug approvals:
http://www.reuters.com/article/us-china-pharmaceuticals/china-to-accept-overseas-trial-data-in-bid-to-speed-up-drug-approvals-idUSKBN1CE080
G-I agree, IMO the delay is based on the significance of either decision to address the illegal importation of a drug. Obviously whatever the ITC decides will only be the start of litigation; the "losing" party will no doubt file legal actions after.
The DS industry will have limited legal options; Amarin's options are very open if the ITC fails to take the "proper" actions. (This includes openly suing US Government for "Regulatory Takings") Regulatory Takings is bullet proof after successful R-I study.
BB
Hi Dew....
Am I disparaging the Biotechs Values board ?...Nah..Well maybe some of your posters,,,But never you...
Actually iwfal's observation about the the all cause mortality numbers in JELIS has given me a semi Eureka moment...I went back and started looking at different country's death rates for different causes and it hit me that like so many other things in biology..there likely has to be a balance in the EPA/AA ratio...It makes sense there is a "dark side" if the EPA/AA ratio gets too high it could increase the risk for infectious disease or bleeding problems notably hemorrhagic stroke. Even if it cuts the CVD event risk down.
Another observation is the surprising number of GI carcinomas listed in the Japanese causes of death...This could be the result of chronic irritation from n-3s...Although Japanese have an unbelievably high incidence of lactose intolerance and that might have something to do with it...
On the whole EPA is going to have a huge effect on CVD risk...CVD is more of a problem in the west than it is in Japan..and that is definitely an EPA/AA ratio issue...I think the company needs to monitor EPA/AA ratios in its study because there is likely an optimal range...Getting the dose right is going to be very important in the future.
Hope all is well up in Wellesley....Regards..":>) JL
m-
Thank you Judge! Imo, so while it is in their jurisdiction, if DS industries are clean, ITC would have denied accepting Amarin's case already. Waiting period is telling a Amarin win, imo.
Once again I have to ask, are you 70-something, or twelve? I can see it right now, if ITC doesn't take the case and the stock drops by 11%, Whal will be all over HDG. "You said it would only drop by 10%. You were wrong HDG." Why don't you tell us what the price will do?
Thanks you for your discussion of items 1)-4) in your post. My current PCP and I both are aware of the considerations you mention in 1)-3), and the endo I consulted in May certainly did discuss the many newer alternative therapies that you mention in some detail with me.
I likely will forward the subject matter I have posted regarding my own "trial" to JRDF, including any further developments, for any comment they wish to make.
Thank you for your good wishes, Ralphey...I am familiar with the privately held company you mention in addition to other stem cell and cell-regeneration companies, particularly PMCB, that are engaged in what appears to be competitive technology. [I participated in a certain patent infringement suit, now settled, involving many such companies].
Much like Amarin in its R-I trial , each appears to be focused, inter alia, on taming diabetes, albeit in a different way[composition and method] from Amarin.
I'll be waiting for that "ad appearance" call, BB, but likely in Vain. Countless strangers have asked me whether I am a radio announcer[voice quality], and i have contemplated a 3rd career in voice-overs. Joining many others, even the barrista at SBUX today thought I was 60, not 80, appearance-wise.
I posted earlier that Tom Brady would be an ideal ad content/narrator person if he were to obtain an off-label scrip for Vascepa, and not be disqualified from that roll by the Patriots' appearance in the SUPER BOWL.
ITC has jurisdiction, IMO, and needs neither advice/opinion from FDA nor us in determining that initial question.
Thanks JL, for a reminder of earlier publications and videos of University of Alabama animal studies and planned human studies I had read about but had forgotten:
https://clinicaltrials.gov/ct2/show/NCT02372253
I have never been prescribed a calcium channel blocker as a BP medication. The above Phase 2 trial is recruiting. I may send the results I posted earlier[in #s '647 and '661 & incorporated partially in my letter to J.T at Amarin] to the lady P.I to see what she thinks. Age-wise, I would be excluded from the above study.
"So Raf wants to know what will happen to the PPS if the ITC declines to proceed"
BS.I don't care.
K-
HDG ...sorry , didn’t see your reply
So less then 10% hit to PPS , according to you ....and temporary .
Well I’ll give you credit for bold , non wishy / washy statements .
So let’s see how you do ...I, m rooting for U. ( rooting ...such a strange American verb )
Kiwi
HDG. Looks like you avoided my question
“ What will happen to the PPS if the ITC declines to take the case “?
RAF , Marz et al want to know .
Kiwi
K-
K-
It looks like you did not understand my post: your options could expire worthless, meanwhile I am right ... ITC does not have to decide till October 20 ... they could issue a new postponement.
Best,
G
All Cause Mortality (part 2)...
Looking at the mortality profiles between Japan and the USA we note some large differences...The first is coronary artery disease CAD is the clear winner as the leading cause of death in the USA and nothing else is even close...However in Japan it is only number three behind Stroke and pneumonia...The other thing to notice is the USA CAD rate is 78 deaths for every 100,000 persons two and a half times higher than the Japanese rate of 30...We know this is not due to genetic resistance to atherosclerosis and CAD from observing traditional Japanese who move to America and adopt the American diet..Their CVD rates are higher than the USA average...
Of other interest is the surprising fact the the second leading cause of deth in Japan are respiratory infections...I believe these observations are consistent with what we know about the higher dietary intake of EPA and the higher EPA/AA in Japan as compared to the USA. We know the EPA/AA ratio governs the resting level of systemic inflammation the higher the EPA/AA ratio, the lower the resting inflammation...That would serve to lower the incidence of CAD which like all degenerative processes is driven by inflammation...And might very well lower resistance to infection which is protected by higher inflammatory levels...There might also be a slight increase in hemorrhagic stokes over the beneficial effects of EPA on thrombotic strokes....Stokes had a rate which was 8 higher in Japan than the USA...
I believe the all cause mortality comparison between the two JELIS arms is not very germane...The placebo arm in JELIS was no where near a real placebo...as defined as the EPA/AA ratios in the R-I in the USA, Europe and places other than Japan...Comparing the event rates in the placebo arm in JELIS to the placebo arm in R-I is apples and oranges.. The JELIS study itself showed the CVD event risk..did line up with the EPA/AA ratios, and this was the case regardless of which arm of JELIS the patient was in.
Seeing a non impressive improvement or lack of improvement in all cause mortality in R-I would be very disappointing...But JELIS does not predict that...The R-I control arm is not going to have EPA/AA ratios in the therapeutic range as JELIS did...So we are going to see more CVD deaths in R-I and more of reduction in the active arm in this cohort whose risk of CAD death is two and a half times greater than than that in JELIS...The problem in JELIS was almost 75% of the enrollees were at negligible risk for cardiac death...only 60 deaths from coronary events in the entire trial...only 12-13% of the total number of events...
":>) JL
HDG yes I expect my options to expire worthless ...if you are wrong .
So, U better not be ...
Kiwi
HDG its a binary event in the sense that if the ITC has jurisdiction ( I would think they are discussing this with the FDA ) ...then the investigation will be fairly fast .
If however its decided that the FDA has jurisdiction ...this will drag on a lot longer then anyone expects .
So Raf wants to know what will happen to the PPS if the ITC declines to proceed ...your view ?
Kiwi
K-
How would it be any different than it was before the ITC case? Be specific.
Raf re pt 3)
In my view its better to hedge positions around binary events ....and the ITC decision will IMHO be a binary event . So I would not buy call options if I already owned the stock
Re pt 1) ..If ITC does not accept , AMRN will be in same situation as they were before this case began
Nope , very much disagree ...stock will be lower and I would expect insurance co's to push for DS options ...if R-IT succeeds ...( screened thru a Co like ConsumerLab ) for primary intervention (ie non stented patients and non CABG patients ) .
JMO
Kiwi
raf...
raf...I for one appreciate iwfal bringing this interesting fact to our attention...As he puts it, "More people died in the EPA arm in JELIS than in the placebo arm than did in the EPA arm." That is a fact and it need" to be explained...Facts are there was not a great deal of difference between the two arms and this was nowhere near statistical significance so that the AHA called the result a tie...
That all begs the question of why if EPA is such an effective reducer of CVD events and a very high safety profile ..Why is this not reflected in the all cause mortality.
So here is my take...
First of all everyone on this board should understand that diet for the most part and not genetics (in most cases)..Determines your health..This fact is amply demonstrated when you begin to look at all cause mortality in different countries of the world...The rule generally speaking is when immigrants adopt the dietary habits of the host country they also develop the disease and death profiles..And these profiles vary tremendously from country to country...
So lets look at two countries of interest. The United States and Japan....
On this board we all know Japanese diet is very high in fish which promotes high EPA/AA ratios which we believe promotes healthy hearts....The USA diet is high in carbs (high glycemic index variety) and processed foods which are high in AA...Not so good for the heart.
So does all cause mortality back that up?
Listed here are the 10 most common causes of death Japan (there might be some surprises)...Included is a rate which represents the number of deaths annually per 100,000 persons...Listed in order of rate
1) Stroke....rate 34
2) Pneumonia and influenza...rate 32
3) Coronary heart disease....rate 30
4) lung cancer........rate 21
5) Suicide.........rate 19
6) Stomach cancer...rate 15.6
7)Colo-rectal cancer rate....rate 14.8
8)Injuries.....rate 13.8
9)Breast cancer...rate 10.7
10) Liver cancer...rate 9,4
Compared to similar USA moralities..
1) Coronary heart disease....rate 78
2)Alzheimers......rate 45
3) Lung Cancer...rate 35
4) Lung disease...rate 30
5) stroke....rate 26
6) Breast cancer....rate 19
7) Prostate cancer 15
8) T2DM and T1DM....rate 14.7
9) hypertension...rate 14.6
10) Colo-rectal cancer....rate 13
To be continued ....under All Cause Mortality part two...
":>) JL
m-
Are you disparaging the Biotech Values board? :- )
kiwi, there is no point of discussing whether ITC take the case or not. They have no choice: they have to either take it or kick it to FDA. It will be interesting if it goes to FDA. If FDA sides DS industry, this is where BB will be very excited because Amarin's high profile legal team will pound FDA again for the third time with all possible suits Arbitrary & Capricious or Takings clause or something else we don't know. Amarin's management waited this long because they thought out well before they go after DS and they understand the risk they get into if they lose. Like Raf said they have warchest of patents to protect V and claim damages thereafter. They are determined to win this case and they are prepared to take it any extent,imo. So, I see no tanking of the pps, only I see price going up.
Rose, the ITC win would triple the pps easily because of the potential expansion in sales, imo. Pps may not spike at once but in a few weeks it could reach $12 and by March it could go past $20 hoping RT success. ITC win might come with the support from FDA either directly or silent. When you win FDA's blessings in the ITC case, it may mean FDA knows something positive about RT success. All these circling reasoning will lead to positive price action incessantly, imo. So buying calls into the future will pay off handsomely in the case of the ITC win. Right now the premiums are so low that one can risk with few dollars.
1. If ITC does not accept, Amarin will be in the exact same situation as they were before this case begin.
2. Did you forget about patents, NCE w/ 30 month extension.
3. But this is not what your initial point was - you changed topics again. Your initial point was that you should not buy options if you already have a long position -- I simply asked you what one has to do with another, but you will not answer.
Rose ...sorry , I'm the wrong person to ask about doubling or tripling of PPS .
IMHO AMRN needs the ITC to accept their case. I'm assuming the 3 wk delay on deciding is to allow the FDA and ITC to agree on who has jurisdiction and possibly whether these are drugs or dietary supplements .
If the ITC does not accept the case then I'm negative on the stock .
I also don't expect R-IT to show the RRR that most on this board expect .
JMO
Kiwi
Raf ...my pt ?
If the ITC does not accept AMRN's case I see this as very negative for the stock . So if you own a lot of stock expect a bigger hit then simply the call options you might own . ( depending on number of options etc )
Amarin acknowledges the risk of dietary supplements reducing their market .
" Amarins coupon plan was designed to make Vascepa price competitive with Synthetically Produced Omega -3 Products and to discourage physicians and pharmacists from directing consumers to purchase ( DS ) products based on price "......#237 in their complaint .
JMO
Kiwi
Kiwi, reading all this discussion of call options w/respect to speculating on an ITC action, peaked my interest in this question:
How much impact on the pps would a positive ITC action be? I would think that R-I results would still be the major controlling influence over the pps, but does anyone think a positive decision long before R-I results could double or triple the pps?
"if you are wrong you obviously increase your loss"
And if you are right, you obviously increase your gains.
"If the ITC... x 6..."
Can easily be summarized as:
If the news is good, stock and options rise. If the news is bad, both fall.
What is your point and what relevance does this have to do with owning the stock?
Marz ...2 weeks ago you were saying anyone who bt AMRN call options was an idiot .
Now you want to buy call options ?
By the way ...I expect to lose this money, but have bt the options just in case ...just in case I'm wrong
Kiwi
Raf ...well if you are wrong you obviously increase your loss ..
If the ITC does not accept AMRN's case then the stock will drop and your calls will probably be wiped out.
You can look at this thru various scenarios
ITC declines case ...stock drops , options wiped out
ITC declines case ...stock drops but you had sold calls and that limited your loss
ITC declines case ...stock drops but you had bt puts as a hedge and that limits your loss
ITC accepts case ....stock jumps and options are profitable
ITC accepts case ...stock jumps but since you had sold calls your gain is limited
ITC accepts case ...stock jumps but your puts are worthless.....limiting your net gain.
You don't own the stock ...so you buy the calls . Upside possible gain ( ITC accepts case ) may be 5 times that of maximum possible loss ( ITC declines case )
Can anyone think of any other combinations ?
Kiwi
yea what is wrong playing options short term? he is still not telling me what strikes he got.
Kiwi - that is your opinion. My opinion is completely different (shocker). I think that telling people "never buy call options if they already own the stock" (although I'm not accusing you giving anyone trading advice) is like Bernie Sanders telling people that certain people have too much money, although he himself owns three homes.
What is wrong with someone having a long position and wanting to gamble on a short-term play, like the ITC ruling - what does one have to do with the other?
Marz ...your post from 2 wks ago
Amarin call buyers are number one idiots - learnt from my own experience. Kiwi enticed me suggesting to buy calls speculating a ITC win. No No I am not buying options any more definitely no more AMRN options in my life.
Highlighted to make a pt .
So regarding me " enticing you " . I am not enticing you to do anything other then to try and LEARN from your experiences .
For myself ...I would never buy call options if I already owned the stock . I would consider hedging my position tho, as has been discussed many times.
JMO
Kiwi
N - I don't disagree with you and CAD but the best way (IMO) to deal with these people is with facts, substance and logical arguments.
What is his argument? That all cause death in Jelis had a P value of 0.333... what is he trying to say with that?
It is funny how predictable they are. They also have that same sarcastic style to their posts. Time is running out so we should see more of these. It actually makes me feel that much more comfortable with this long term investment. Outside of my DD of course.
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.
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