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BioBill: Been an investor since 2012. I pretty much follow only you and Jesse... Can you reply to this with a few bullet points in 2nd grade english as I like to say for my own edification explaining what patents are currently being challenged by the Generics and whether or not you feel Amarin will Lose, Settle, or Prevail?
I catch tidbits yet only from time to time in your posts yet I know you are concerned and focused on this.
Also can you tell me if you feel these challenges are the top major issue Amarin faces in the foreseeable future?
I feel the FDA is a thorn yet the Company will get past all their BS.
Appreciate your insight!
Thank you for all of your contributions!
ALZHEIMERS: NBC Nightly News (6:30 pm EST) just had a story saying a Massachusetts General Hospital Study reveals: "Inflammation seen as possible factor in Alzheimer's"... They believe "Inflammation is killing millions of nerve cells in the brain" (By Dr Rudy Tanzi). Just another possibility for Vascepa!
VASCEPA: I live in NJ and just received my new License Plate: VASCEPA
I wish I could post a picture of it here...
I might drive into Amarins' parking lot, park in a few key spots, and take a pic or two!
Or do a few donuts to get their attention so they know I am a big fan!
Guess who Sold Today...
(I have been invested since 2012. I have 22,000 Shares and have not sold a single one since 2012...)
I rarely chime in here yet ask:
Who Sold Today? Who Bought Today?
The "NEW Longs" are asking: Who Sold today?
The real question is: Which Longs bought on the news? The answer is basically NONE because we already "get it"...
The other question to ask is: Which Longs sold on the news? The answer is basically NONE and once again it is because we already "get it"...
So who sold?
The Market Makers did hoping to drive the fear and concern into the "New Longs" making them think "maybe I missed something in the Conference Call???" And "I cannot afford to drop to 18.00 so I will sell and maybe get back in when I figure out what went wrong!" This is why I call them the "new longs" because they think they are Long yet they just cannot hang in there for one reason or another and they get exploited...
By who?
The Market Makers are 100% intentionally driving fear into those who are not TRUE LONGS, or are NEW LONGS, or people who are basically tapped-out and cannot afford to lose a dime. They are trying to get to your Stops or force you to sell thinking "something is wrong with the news..."
And it works every time...
True LONGS do not sell on the news and True LONGS do not buy on the news because they are already fully vested and invested!
Those that sold or whose stops took effect were forced to sell right along with the Market Makers who pushed the price lower... The have the volume to do it and can make a stock like this move...
Did the Shorts sell: Probably because the news got even better... Did they help drive the fear? Yes they did; you can count on that...
Institutional Investors did not sell either...
So I will ask again: Who Sold?
Not me...
...And I do believe we are in a bit of a bubble that will correct itself in a modest way... Not like 2008/2009 did...
The Stock Market Drop is mirroring Interest Rates Rising...
Amarin Drop:
Lots of new-comers taking year end profits and losses... Keep in mind - a lot of new buyers (not long-term believers/followers) jumped on when the news broke (3.00 to 11.00 buyers) then there were the next not so tuned in group that jumped on between 11.00 to 23.00... Short term profit takers and many lost (those who bought in at 20.00 to 23.00 and are now sitting on a 14.00 value who want to write off the loss (because they are traders and not investors)...
Next Jump:
Great Partner on-board announcement, Buy-out Rumor, Buy-out, and/or FDA Label Approval...
Been here hiding since 2012... Rode it down from 18.00 per share to .78 per share, back to 23.00 per share, and still holding...
(345,000.00 investment made it to 17,000.00 then well over 345k and wherever I am now... And who cares...)
Why - Because I am an Investor and not a Trader...
And all the Thanks to JL and BB... Never stopped following them!
When I get Depressed I try to recall all of the good going on and ignore the Conspiracy Theories - they get old...
Here is something I wrote a while back that keep the "conspiracy theories" at bay in my mind:
"Let me play Devil's Advocate for a Minute..."
Important to note before reading this:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
Let me play Devil's Advocate for a Minute:
1. A Company called GSK has a product called Fish Oil.
2. The Company markets and sells it successfully for years.
3. A new Company comes along, takes their product, cleans it up
a bit, then calls it something else and wants to sell it to
everyone and call it their very own idea.
Here is what the FDA has done so far:
1. Approve Vascepa
2. Say it is not a 100% new creation
3. Gave it 3 years + 30 months of protection
4. Asked the Company to continue with its testing to see if it
reduces Cardio Vascular Events
5. Said it is VERY interested (via AdCom participants) to see the
outcome of the long term (Reduce-It) testing
6. Said it is willing to approve Anchor if it proves it can do
more than Reduce Trigs
It appears from this perspective that the FDA believes in the product yet wants to be sure to protect the creation of the original product.
NOW: From another perspective...
1. How would this board react if the FDA completely rejected the
product from the very beginning?
2. How would this board react if the FDA allows another product
that cleans Vascepa up a little bit more and OK's it?
3. How would the board feel if the FDA said: You cannot create and
use this product knowing GSK's product is out there and they
can clean theirs up a bit more and do the very same as Vascepa?
4. How would the board feel if the FDA told Amarin to stop Reduce-
It knowing GSK could clean up their product and successfully
run the same testing as Reduce-It?
In short:
It looks like the FDA is allowing Vascepa even though it closely resembles GSK's product, it is allowing Vascepa to exist and sell, and it is asking (via AdCom) to continue testing to see if it will Reduce CVE's... It is also allowing Vascepa to do additional testing for other conditions like Dry Eye, Inflammation...
It ALL sounds Great to me...
Could the FDA just be protecting GSK's hard work YET know GSK's product is in the past and about to be completely over-run by Vascepa?
This is an interesting perspective full of Positive...
All I read on this board is what we as investors do not have and how we've been screwed...
What we do have is an excellent product on an excellent path with NO failure and is a safe product making slow and careful headway into Big Pharma's world...
IF Vascepa proves to be successful beyond everyone's dreams, why expose yourselves to the continued negativity of the "leaders" of this board?
IF Vascepa fails to prove any positive CVE reduction with Reduce-It, then where will all the "Let's Kill the FDA" people on this board end up then and how much value will the current "Kill position" be worth (then)?
I will end with this as I have before...
As Warren Buffet said:
Do not invest in a company unless you are willing to stay invested for 10 years or more and do not invest money you will need during the sane time!
In closing and to repeat:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
...in good time while hitting a few bumps in the road!
The BEST products go thru the most rigorous testing, challenges, and scrutiny...
...and ALL of the best products succeed!
CAPTBEER: I've tried to stay away from the Board until 2016 or 2017 yet check in from time to time...
This position written by CaptBeer is exactly why I am staying long...
It is exactly what Jesse explained years ago and still explains today.
Hopefully one of two things happens:
1. We make it to 2017.
2. We get a nice offer from BF to cover our investment.
Obviously we all hope for #1...
Here is something I wrote a while back that keep the "conspiracy theories" at bay in my mind:
"Let me play Devil's Advocate for a Minute..."
Important to note before reading this:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
Let me play Devil's Advocate for a Minute:
1. A Company called GSK has a product called Fish Oil.
2. The Company markets and sells it successfully for years.
3. A new Company comes along, takes their product, cleans it up
a bit, then calls it something else and wants to sell it to
everyone and call it their very own idea.
Here is what the FDA has done so far:
1. Approve Vascepa
2. Say it is not a 100% new creation
3. Gave it 3 years + 30 months of protection
4. Asked the Company to continue with its testing to see if it
reduces Cardio Vascular Events
5. Said it is VERY interested (via AdCom participants) to see the
outcome of the long term (Reduce-It) testing
6. Said it is willing to approve Anchor if it proves it can do
more than Reduce Trigs
It appears from this perspective that the FDA believes in the product yet wants to be sure to protect the creation of the original product.
NOW: From another perspective...
1. How would this board react if the FDA completely rejected the
product from the very beginning?
2. How would this board react if the FDA allows another product
that cleans Vascepa up a little bit more and OK's it?
3. How would the board feel if the FDA said: You cannot create and
use this product knowing GSK's product is out there and they
can clean theirs up a bit more and do the very same as Vascepa?
4. How would the board feel if the FDA told Amarin to stop Reduce-
It knowing GSK could clean up their product and successfully
run the same testing as Reduce-It?
In short:
It looks like the FDA is allowing Vascepa even though it closely resembles GSK's product, it is allowing Vascepa to exist and sell, and it is asking (via AdCom) to continue testing to see if it will Reduce CVE's... It is also allowing Vascepa to do additional testing for other conditions like Dry Eye, Inflammation...
It ALL sounds Great to me...
Could the FDA just be protecting GSK's hard work YET know GSK's product is in the past and about to be completely over-run by Vascepa?
This is an interesting perspective full of Positive...
All I read on this board is what we as investors do not have and how we've been screwed...
What we do have is an excellent product on an excellent path with NO failure and is a safe product making slow and careful headway into Big Pharma's world...
IF Vascepa proves to be successful beyond everyone's dreams, why expose yourselves to the continued negativity of the "leaders" of this board?
IF Vascepa fails to prove any positive CVE reduction with Reduce-It, then where will all the "Let's Kill the FDA" people on this board end up then and how much value will the current "Kill position" be worth (then)?
I will end with this as I have before...
As Warren Buffet said:
Do not invest in a company unless you are willing to stay invested for 10 years or more and do not invest money you will need during the sane time!
In closing and to repeat:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
...in good time while hitting a few bumps in the road!
The BEST products go thru the most rigorous testing, challenges, and scrutiny...
...and ALL of the best products succeed!
CVE in Anchor Application:
They did not ask for it YET the basic premise of Vascepa was and always has been an ultimate reduction in CVE's which is basically their Company credo... They noted the letters CVE in their application.
This has always been why the FDA has put the brakes on Vascepa...
Once Vascepa proves a reduction in CVE's, the FDA will approved it...
I spoke to Joe Bruno the week after they lost their fight back in October asking him why they had the letters CVE in their application and his reply was: You generally always put your goal in your application.
I asked him if they would request an extension of the Marine Label approving treatment of those with High Trigs now that they failed with Anchor and he said YES...
Meaning go back and modify the application removing any CVE language, lettering, or whatever you care to call it and just go for what we all thought they were going for and that was always JUST AN EXTENSION OF THE MARINE LABEL...
Unfortunately the FDA decided to demand proof because of so many other failures and bad publicity over the last many years including Fibrates and Niacin.
No one from the FDA ever said Amarin and Vascepa will not work - they just said prove it...
See you again in 2016!
Long 17k shares at 13.00 per share!
sts66 - Thanks for the info!
EPA DRUG INITIATIVE: Is there a time-frame/deadline as to when the FDA "must" reply to the Citizens Petition filed? I say "must" in quotes wondering if there is an FDA rule and/or guideline that states how long they can sit on it without replying...
Chabojilo - So you are perfectly OK with someone taking Vascepa and modifying it to show an added benefit and it is 100% perfectly OK to call it a completely new compound and it is perfectly OK for that company to take market share from Vascepa?
Are you 100% perfectly OK with that?
Just say YES - I want to hear it again...
"Let me play Devil's Advocate for a Minute..."
Important to note before reading this:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
Let me play Devil's Advocate for a Minute:
1. A Company called GSK has a product called Fish Oil.
2. The Company markets and sells it successfully for years.
3. A new Company comes along, takes their product, cleans it up
a bit, then calls it something else and wants to sell it to
everyone and call it their very own idea.
Here is what the FDA has done so far:
1. Approve Vascepa
2. Say it is not a 100% new creation
3. Gave it 3 years + 30 months of protection
4. Asked the Company to continue with its testing to see if it
reduces Cardio Vascular Events
5. Said it is VERY interested (via AdCom participants) to see the
outcome of the long term (Reduce-It) testing
6. Said it is willing to approve Anchor if it proves it can do
more than Reduce Trigs
It appears from this perspective that the FDA believes in the product yet wants to be sure to protect the creation of the original product.
NOW: From another perspective...
1. How would this board react if the FDA completely rejected the
product from the very beginning?
2. How would this board react if the FDA allows another product
that cleans Vascepa up a little bit more and OK's it?
3. How would the board feel if the FDA said: You cannot create and
use this product knowing GSK's product is out there and they
can clean theirs up a bit more and do the very same as Vascepa?
4. How would the board feel if the FDA told Amarin to stop Reduce-
It knowing GSK could clean up their product and successfully
run the same testing as Reduce-It?
In short:
It looks like the FDA is allowing Vascepa even though it closely resembles GSK's product, it is allowing Vascepa to exist and sell, and it is asking (via AdCom) to continue testing to see if it will Reduce CVE's... It is also allowing Vascepa to do additional testing for other conditions like Dry Eye, Inflammation...
It ALL sounds Great to me...
Could the FDA just be protecting GSK's hard work YET know GSK's product is in the past and about to be completely over-run by Vascepa?
This is an interesting perspective full of Positive...
All I read on this board is what we as investors do not have and how we've been screwed...
What we do have is an excellent product on an excellent path with NO failure and is a safe product making slow and careful headway into Big Pharma's world...
IF Vascepa proves to be successful beyond everyone's dreams, why expose yourselves to the continued negativity of the "leaders" of this board?
IF Vascepa fails to prove any positive CVE reduction with Reduce-It, then where will all the "Let's Kill the FDA" people on this board end up then and how much value will the current "Kill position" be worth (then)?
I will end with this as I have before...
As Warren Buffet said:
Do not invest in a company unless you are willing to stay invested for 10 years or more and do not invest money you will need during the sane time!
In closing and to repeat:
I am a highly invested and LONG investor who believes in the product and the science.
I am confident that Vascepa will turn into a HUGE and SUCCESSFUL product...
...in good time while hitting a few bumps in the road!
The BEST products go thru the most rigorous testing, challenges, and scrutiny...
...and ALL of the best products succeed!
Interesting Article about a Different Product and Why it Received 3 Years instead of 5:
http://ehoganlovells.com/rv/ff000ba2265e016b88cc630cea42b3d7995a45df
rafunrafun Back to the Pre-drop numbers - Hitting 20.00 immediately then climbing as Buy-out Rumors start again in the 30's to 40's...
I remember buying in at 7.00 and selling at 7.25 only to watch the jump go to 20.00 a few days later!
I was sick to my stomach because I was not in for that one!
ggwpq - The problem I have with your statement that the FDA believe's treating Trig's in the 200 to 500 class is a must has not been documented or even stated casually (meaning not legally documented) by the FDA...
If there was a health issue for that class, Amarin could go for it or may have been approved for it like the FDA approved Vascepa in the Marine class...
There is none.
The FDA allowed Marine not because it reduce's CVE's yet ONLY because reducing Very High Trig's helps reduce the risk of Pancreatis.
Without that Medical Condition we would not have an approved product.
If you can find a Health Condition that the FDA agrees is helped by the Reduction in Trig's in the 200 to 500 class, I am sure all of us on this board would like to see it.
It unfortunately does not exist.
If you stop and think:
The FDA did not say that Reducing Trig's will not reduce CVE's...
All they said is there is no current test that they can (or will accept) that shows a reduction in Trig's reduce's CVE's...
They said the Fibrate and Niacin studies did not prove a reduction in CVE's... They are 100% correct yet (let me finish...):
LISTEN to what I am about to say closely: They basically said that the Fibrate and Niacin tests did not show a reduction in CVE's meaning (what they should have said is) they are bad tests for the endpoint that Vascepa is shooting for...
We all keep arguing that those tests cannot be used against Vascepa. They are NOT being used against Vascepa. They are not even in the same class of testing that Reduce-It is going to prove... It is like saying reducing weight will help reduce heart attacks yet the people in the tests were already in the OK weight class so we have no proof... I wholly agree with that statement and position!
What the FDA should have said was the two tests did not meet the same level of testing that Reduce It is undergoing nor can we (we being the FDA and Amarin) use the two tests to support or deny that Reducing Trig's will help reduce CVE's...
No one on this board has ever said: "The FDA should have allowed the tests because they did show what we are looking for..."
We all agree - Investment community and the FDA that the two tests were useless for helping Vascepa's cause!
We all agree with the 99% of the Dr's who say reducing Trig's is a must.
To cut right to the chase: I long for the end of the Reduce-It trial knowing the Medical Community will have proof that the Reduction in Trig's will help reduce CVE's...
Reduce It will be the 2nd (Jellis being the first) and the only US approved test to show a reduction in Trig's will show a proven reduction in CVE's.
The longs who can lose or live without the investment money are feeling good inside and can sleep at night including myself.
Those who wanted a short term check or those who do not believe in the science are feeling their oats right now.
I am a major believer in the science...
I'll will resort to my fall back comfort: As Warren Buffet once said - "Consider an investment a 10 year plan and only invest money you do not need during the same period"... (In more or less words.)
Sit back and look forward to 2018 (or hopefully sooner!)
ggwpq - No proven benefit in the eye's of the FDA (I could have added that yet thought it was obvious...) If the FDA thought or thinks there is a Proven Benefit or reducing Trigs below 500, they would or should or still can approve Vascepa with a modified label...
As of now they have NO PROOF of a Health Benefit of reducing Trigs below 500.
I like you completely disagree with that position YET the FDA is fact driven so once Amarin can produce something that shows a benefit of reducing Trigs below 500, we can apply for that benefit and sell the drug for that reason (with the FDA's backing)...
The key is to get their backing. They are basically the Gate Keeper to Doctors...
Hmmm - Is Fish Oil Effective for anything?
From an article on line:
http://www.nlm.nih.gov/medlineplus/druginfo/natural/993.html
How effective is it?
Natural Medicines Comprehensive Database rates effectiveness based on scientific evidence according to the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, Ineffective, and Insufficient Evidence to Rate.
The effectiveness ratings for FISH OIL are as follows:
Effective for...
High triglycerides. High triglycerides are associated with heart disease and untreated diabetes. To reduce the risk of heart disease, doctors believe it is important to keep triglycerides below a certain level. Doctors usually recommend increasing physical activity and restricting dietary fat to lower triglycerides. Sometimes they also prescribe drugs such as gemfibrozil (Lopid) for use in addition to these lifestyle changes. Now researchers believe that fish oil, though not as effective as gemfibrozil, can reduce triglyceride levels by 20% to 50%. One particular fish oil supplement called Lovaza has been approved by the FDA to lower triglycerides. Lovaza contains 465 milligrams of EP and 375 milligrams of DHA in 1-gram capsules.
Likely effective for...
Heart disease. Research suggests that consuming fish oil by eating fish can be effective for keeping people with healthy hearts free of heart disease. People who already have heart disease might also be able to lower their risk of dying from heart disease by eating fish or taking a fish oil supplement. However, for people who already take heart medications such as a “statin,” adding on fish oil might not offer any additional benefit.
Possibly effective for...
High blood pressure. Fish oil seems to produce modest reductions in blood pressure in people with high blood pressure. The omega-3 fatty acids in fish oil seem to be able to expand blood vessels, and this brings blood pressure down.
Rheumatoid arthritis. Fish oil alone, or in combination with the drug naproxen (Naprosyn), seems to help people with rheumatoid arthritis get over morning stiffness faster. People who take fish oil can sometimes reduce their use of pain medications such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Menstrual pain (dysmenorrhea). Taking fish oil alone or in combination with vitamin B12 seems to improve painful periods and reduce the need for pain medications such as nonsteroidal anti-inflammatory drugs (NSAIDs).
Attention deficit-hyperactivity disorder (ADHD) in children. Taking fish oil seems to improve thinking skills and behavior in 8 to 12 year-old children with ADHD.
Raynaud’s syndrome. There’s some evidence that taking fish oil can improve cold tolerance in some people with the usual form of Raynaud’s syndrome. But people with Raynaud’s syndrome caused by a condition called progressive systemic sclerosis don’t seem to benefit from fish oil supplements.
Stroke. Moderate fish consumption (once or twice a week) seems to lower the risk of having a stroke by as much as 27%. However, eating fish doesn’t lower stroke risk in people who are already taking aspirin for prevention. On the other hand, very high fish consumption (more than 46 grams of fish per day) seems to increase stroke risk, perhaps even double it.
Weak bones (osteoporosis). Taking fish oil alone or in combination with calcium and evening primrose oil seems to slow bone loss rate and increase bone density at the thigh bone (femur) and spine in elderly people with osteoporosis.
Hardening of the arteries (atherosclerosis). Fish oil seems to slow or slightly reverse the progress of atherosclerosis in the arteries serving the heart (coronary arteries), but not in the arteries that bring blood up the neck to the head (carotid arteries).
Kidney problems. Long-term use (two years) of fish oil 4-8 grams daily can slow the loss of kidney function in high-risk patients with a kidney disease called IgA nephropathy. Fish oil also seems to reduce the amount of protein in the urine of people who have kidney disease as a result of diabetes.
Bipolar disorder. Taking fish oil with the usual treatments for bipolar disorder seems to improve symptoms of depression and increase the length of time between episodes of depression. But fish oil doesn’t seem to improve manic symptoms in people with bipolar disorder.
Psychosis. Taking a fish oil supplement might help prevent full psychotic illness from developing in people with mild symptoms. This has only been tested in teenagers and adults up to age 25.
Weight Loss. Some evidence shows that eating fish improves weight loss and decreases blood sugar in overweight people and people with high blood pressure. Preliminary research also shows that taking a specific fish oil supplement 6 grams daily (Hi-DHA, NuMega), providing 260 mg DHA/gram and 60 mg EPA/gram, significantly decreases body fat when combined with exercise.
Endometrial cancer. There is some evidence that women who regularly eat about two servings of fatty fish per week have a reduced risk of developing endometrial cancer.
Age-related eye disease (age-related macular degeneration, AMD). There is some evidence that people who eat fish more than once per week have a lower risk of developing age-related macular degeneration.
Reducing the risk of blood vessel re-blockage after heart bypass surgery or “balloon” catheterization (balloon angioplasty). Fish oil appears to decrease the rate of re-blockage up to 26% when given for one month before the procedure and continued for one month thereafter. When taken for less than one month before angioplasty, fish oil doesn’t help protect the blood vessel against closing down.
Recurrent miscarriage in pregnant women with antiphospholipid syndrome. Taking fish oil seems to prevent miscarriage and increase live birth rate in pregnant women with a condition called antiphospholipid syndrome.
High blood pressure and kidney problems after heart transplant. Taking fish oil seems to preserve kidney function and reduce the long-term continuous rise in blood pressure after heart transplantation.
Damage to the kidneys and high blood pressure caused by taking a drug called cyclosporine. Cyclosporine is a medication that reduces the chance of organ rejection after an organ transplant. Fish oil might help reduce some of the unwanted side effects of treatment with this drug.
Movement disorder in children (dyspraxia). Taking fish oil orally, in combination with evening primrose oil, thyme oil, and vitamin E (Efalex, Efamol Ltd), seems to improve movement disorders in children with dyspraxia.
Developmental coordination disorder. A combination of fish oil (80%) and evening primrose oil (20%) seems to improve reading, spelling, and behavior when given to children age 5-12 years with developmental coordination disorder. However, it doesn’t seem to improve motor skills.
Preventing blockage of grafts used in kidney dialysis. Taking fish oil orally seems to help prevent clot formation in hemodialysis grafts.
Psoriasis. There is some evidence that administering fish oil intravenously (by IV) can decrease severe psoriasis symptoms. But taking fish oil by mouth doesn’t seem to have any effect on psoriasis.
High cholesterol. There is interest in using fish oil in combination with “statin” drugs for some people with high cholesterol. Doctors were worried at first that taking fish oil might interfere with statin treatment, but early studies show this is not a problem, at least with the statin called simvastatin. Scientists think fish oil may lower cholesterol by keeping it from being absorbed in the intestine. There is some evidence that using vitamin B12 along with fish oil might boost their ability to lower cholesterol.
Coronary artery bypass surgery. Taking fish oil seems to prevent coronary artery bypass grafts from re-closing following coronary artery bypass surgery.
Cancer-related weight loss. Taking a high dose (7.5 grams per day) of fish oil seems to slow weight loss in some cancer patients. Some researchers believe these patients eat more because the fish oil is fighting depression and improving their mood.
Asthma. Some research suggests fish oil may lower the occurrence of asthma in infants and children when taken by women late in pregnancy. Furthermore, fish oil seems to improve airflow, reduce cough, and lower the need for medications in some children with asthma. However, fish oil treatment doesn’t seem to provide the same benefit for adults.
Possibly ineffective for...
Chest pain (angina).
Gum infection (gingivitis).
Liver disease.
Leg pain due to blood flow problems (claudication).
Preventing migraine headaches.
Preventing muscle soreness caused by physical exercise.
Breast pain.
Skin rashes caused by allergic reactions.
Stomach ulcers.
Likely ineffective for...
Type 2 diabetes. Taking fish oil doesn’t seem to lower blood sugar in people with type 2 diabetes. However, fish oil can provide some other benefits for people with diabetes, such as lowering blood fats called triglycerides.
Insufficient evidence to rate effectiveness for...
Allergies. Some research suggests that mothers who take fish oil supplements during the late stages of pregnancy may lower the occurrence of allergies in their children.
Alzheimer’s disease. There is some preliminary evidence that fish oil may help prevent Alzheimer‘s disease. But it doesn’t seem to help prevent a decline in thinking skills for most people who already have mild-to-moderate Alzheimer’s disease.
Atopic dermatitis. Mothers who take fish oil supplements during pregnancy might reduce the occurrence and severity of atopic dermatitis in babies and children who are at risk for this condition. But fish oil doesn’t seem to be effective for treating atopic dermatitis.
Atrial fibrillation. Research studies into the effects of fish oil on atrial fibrillation have produced conflicting results.
Depression. There is inconsistent information about the effect of taking fish oil on depression. Some research shows that taking fish oil along with an antidepressant might help improve symptoms. But other research shows that taking fish oil does not improve symptoms.
Dry eye syndrome. Some research links eating more fish with a lower risk of getting dry eye syndrome in women. Some preliminary clinical research also suggests that taking a specific product containing fish oil plus flaxseed oil (TheraTears Nutrition) might reduce symptoms of dry eye and increase tear production.
Cancer. Research studies into the effects of fish oil on cancer prevention have produced conflicting results.
Cataracts. There is some evidence that eating fish three times a week can modestly lower the risk of developing cataracts.
Chronic fatigue syndrome (CFS). There is some conflicting evidence about the use of a product (Efamol Marine) that combines fish oil and evening primrose oil to reduce the symptoms CFS.
Chronic kidney disease. Preliminary evidence shows that fish oil might have benefit for some people with chronic kidney disease who are receiving dialysis treatments.
Thinking skills (cognitive function). Research studies into the effects of fish oil on cognitive function have produced conflicting results.
Crohn’s disease. Research studies into the effects of fish oil on Crohn’s disease have produced conflicting results.
Prediabetes. Early studies suggest that fish oil may help prevent prediabetes from advancing to type 2 diabetes.
Infant development. There is some evidence that mothers who take 4 grams of fish oil daily during the last half of pregnancy may improve their baby’s cognitive development by some measures, but not others. At age 2.5 years, these children seem to have better hand and eye coordination, but reasoning, social, motor, and speech skills are not significantly improved.
Ulcerative colitis. Research studies into the effects of fish oil on ulcerative colitis have produced conflicting results.
Pregnancy complications. There is some evidence that taking fish oil during the last ten weeks of pregnancy can help prevent premature delivery. However, fish oil doesn’t seem to help prevent high blood pressure during pregnancy.
Prematurity. Baby formula that has been fortified with fatty acids from fish oil and borage seems to improve growth and the development of the nervous system in premature infants, especially boys.
Salicylate intolerance. Some limited research suggests that taking fish oil might improve symptoms of salicylate intolerance such as asthma attacks and itching.
Schizophrenia. There is one report of fish oil improving schizophrenia in a pregnant woman.
Systemic lupus erythematosus (SLE). Research shows conflicting results. Some studies suggest that fish oil helps the symptoms of SLE, while others show no effect.
Irregular heartbeat affecting the ventricles (ventricular arrhythmias). Research studies into the effect of fish oil on ventricular arrhythmias have produced conflicting results.
Improving night vision in children with a disorder called dyslexia. Children with dyslexia who take fish oil seem to be significantly better able to adapt to the dark.
67stang - They did not "ask for it" meaning they did not say to the FDA "we want our label to say we are treating CVE's...
It is Amarin's goal as a company.
The FDA took note of this subtle unintentional point and said: Can't happen.
Now if their application did not mention it what would have happened?
Maybe the same exact thing because there is no "proven benefit" of treating Trigs below 500 right now.
That is where the FDA is caught in the middle: The world says there is yet no one has proven it.
So what is the easiest way out: "Prove it"...
(Remember this is part of thew "new and improved FDA"...)
That test is called: Reduce-It
Why all of the hype: We hear a million commercials with "Side Effects" the length of our arms and cannot wrap our heads around the fact that "Fish Oil" is being rejected - I being one of them!
When they submitted their application it was OK to list the intended endpoint (unproven) without fear of rejection yet over the last man years the FDA has taken a rash of failures that ave caused death for doing this... After-all: Amarins creed/motto/direction/intent is basically to help better Cardio-Vascular issues!
I can see the FDA backing away on drugs with certain risks YET the upheaval we are experiencing is we are talking about Fish Oil and one that is better and safer than any other form of it on planet earth!
It is taken everywhere and has virtually NO side effects.
Is Vascepa the Poster child for the FDA?
I truly think if they go for an extension of Marine only (modified Anchor) that is the best opportunity they have.
I do not think their intent was to get an OK to "treat CVE's" yet that added language certainly did not help their cause.
Derailed the train in full and now it is a runway.
The FDA will not approve Anchor as submitted yet if they accept the same "Exceptions" to the label as Marine, maybe the FDA will allow them to sell it (just as they allow Fibrates and Niacin)...
That last sentence makes my stomach sick when I think that we have a next to no side effect product that run circles around the others!
We should hire Larry King as our spokesperson!
John
67stang - You hit that square on the head!
The FDA should be shot for leading them into the Pipeline then cutting off their hands!
This new position should apply to all New applicants!
Your point is the only reason why I am holding out hope that they may give them the 150 to 499 class as an extension of Marine and outright reject Anchor!
I think we can all live with that!
John
67stang - it is NOT just Amarin... Many other companies are now facing the same new "Prove It" mentality of the FDA...
67stang - It was on their application and written by Amarin.
I talked to him directly and ask him why it was added or even on there and he said it is normal to include your true endpoint and/or goal on your label...
It is also their "creed": For Treating People at Risk for CVE's...
Why else do you think they exist? Just to better Lipid Panel Results?
We could ONLY have hoped that was the ONLY path they took with Anchor!
Do you think for a second that Amarin's Anchor submission was only going for the Treatment of people with Trigs in the 150 to 499 group?
Absolutely not...
Here is a press release right from Amarin - do you think the FDA made them put the BOLD CVE language in the article?
It's loud and clear: We are treating people at risk for CardioVascular Disease...
That is like saying consuming Dark Chocolate is good for you so we want the FDA's OK to sell Dark Chocolate because it will reduce High Blood Pressure (see below) when their is no current proof of it... (That is the goal of Reduce-It so the FDA told us to slow the "F" down...)
sts66 - You are 100% correct...
I called Joe Bruno right after Adcom (speaking directly to him for a half an hour or so) and asked if Amarin's goal was to just get an extension of Marine (which makes NO mention of Treating people at Risk for CVE's) to treat those in the 150 to 499 Trig group then why did they add "...Treating People at Risk for CVE's" in their application..
His reply is exactly as you note: "It is normal to list your ultimate goal on the label..."
In my opinion that opened up a pandora's box so large that the FDA just said NO WAY and propelled us into 2017 without an opportunity to "apologize for the mistake"...
I am still hoping to get the extension of Marine to treat those in the 150 to 499 group yet on the other hand I concerned that there currently is no proven end point in the FDA's mind (or "reason") to treat people with that level of Trigs.
In theory we are creating the reason with Reduce-It so why would they give us an OK to treat the 150 to 499 class with their new "must have a proven endpoint" position...
Do you know if Lovaza ever applied for this class and if so how was it received by the FDA?
It is all quite a quandary!
How do you get an approval from the FDA for something that the AHA feels is necessary if there is no proven endpoint and right in the middle of the FDA closing the door to "No Endpoint Approvals"?
I think we need a sponsor with big money like GSK on board - someone with deep pockets who we can work closely with that might help us all cross the goal line with the FDA... AND who can help us start running new Endpoint Testing for other uses of Vascepa.
I have NOT closed my mind to getting the extension as a negotiated agreement YET I suspect we will end up getting a Freedom of Speech ok to add the info to the label...
I like you have no need to sell... I am not emotionally attached YET in complete agreement with the science and feel/know sooner or later that it will succeed!
Here is what I always turn back to:
Warren Buffet once said:
If you plan to "Invest" in a company and/or product, plan to be in for at least (10) years and have no immediate need for the money!
In my case: 275,000.00 invested with a current approx value of 30,000.00.
Works for me and let's me sleep at night!
John
USA TODAY Omega 3 Article: In today's printed newsstand copy:
http://www.usatoday.com/story/news/nation/2014/02/01/fish-oil-heart-brain-health/4972393/
Bio:
Link to the issue:
http://www.idf.org/webdata/docs/Mets_definition_children.pdf
(Old report not from above link yet):
1Bill: Here is the link...
http://www.ft.com/cms/s/2/b3d460be-7800-11e3-afc5-00144feabdc0.html#axzz2rZEcBBm8
Here is another older one:
http://news.yahoo.com/doctor-getting-paid-big-pharma-223900645.html
Nuts: You need to call the AHA and tell them that Lowering Trigs below 150 is not needed...
Same with All of the Doctors and Professionals that Lowering Trigs below 150 is not needed either...
You also need to tell all Doctor's that reducing everything that Vascepa helps on the Lipid Panel is not needed either.
OR
Do you need to call the FDA and tell them to WAKE-UP!
I really want your honest opinion on which is better for the Public.
Your opinion only!
After-all: You are an Investor in Amarin too!
nutsyprofessor
no_mo_Butterfinger - Well he was not exactly wrong. By listing a reduction of CVE's as their ultimate endpoint, they were not lying. It's just that the FDA just changed their rules as to what you can sell, whenyou can sell it, and why you can sell it... They are now requiring endpoint proof and if Amarin's sole goal is to reduce CVE's, the FDA is saying they need to prove it.
On the Marine note:
Vascepa was not created to Improve Pancreatitis. It was an (apparent) doorway into the market. Reducing Trigs though has been proven/tested/assumed (not sure which) to better Acute Pancreatitus so the FDA could not or did not disallow it.
Now they have to somehow convince the FDA without a proven endpoint that taking Vascepa will better peoples lives of people with Trigs between 199 and 500 by bettering Lipid Panel results.
So far the FDA has not said that is NOT an acceptable option.
They just said that Amarin cannot say Vascepa will reduce CVE's.
Until they reject Amarin's request to sell Vascepa to the 199 thru 500 Trig class with the same exception noted on the Marine label regarding "No Proof in a Reduction in CVE's", I will hold out hope that Anchor will be approved in a modified version (again, without any comment about CVE reduction)...
The problem is the FDA is caught between saying YES or NO to the modified version. They want to say YES because it does better the Lipid Panel results yet they want to say no because there is no proof that bettering the Lipid Panel results will reduce CVE's (which is Amarins sole reason for selling the Drug).
YET they did approve Vascepa for treating Acute Pancreatitus YET that was not Amarins reason for selling Vascepa!
Kind of a sick twist or snafu!
That brings me back to hoping the FDA approves Anchor with the exception.
The FDA has NOTHING to lose by putting a product on the market that betters Lipid Panel results...
Or do they: I am open to comments...
jdhartin - You hit that one the head! I've been saying that since they shot them down October 16th... When I heard the FDA focus on CVE's, I called Joe Bruno at Amarin and asked the very same question you asked (Why Not Just get an Approval on the 199 to 500 Trig Class without the CVE language):
His reply was: "That was our intention."
I asked why the Anchor application mentioned CVE's when Anchor was ONLY an extension of Marine (which has an exception to CVE's and is one of the reasons why the FDA approved them the 1st time!)
He said you normally list the ultimate intent in your application when you file a sNDA.
Had Amarin ONLY asked for an extension of Vascepa for the 199 to 500 class with the application noting that the Anchor label will carry the very same exceptions as Marine, we probably would not be talking about this now...
Here is the argument with that position:
As the FDA stated on October 16th:
Vascepa's Marine treats people with Inflammation of the Pancreas which is helped by reducing Very High Trigs.
YET THE FDA MADE THEM PUT ON THE LABEL THAT VASCEPA HAS NOT BEEN TESTED OR PROVEN TO REDUCE INFLAMMATION OF THE PANCREAS!
So right now Vascepa has no proven benefit yet the FDA approved them!?!?!?!?!
So now that the FDA is changing their position on Drug Approvals wanting a definite proven successful endpoint (meaning what does this drug help or cure), we risk having Marine pulled if we use a Reduction of Trigs as the primary and only proven benefit of Vascepa - if it has not proven to benefit anything!?!?!?!?!)...
After-all, it has not been proven to reduce the effects of Inflammation so what does it do?
We either have to get the FDA to agree that a reduction of High Trigs (200 to 499) is effective for something without a proven endpoint or we have to wait for Reduce-It to prove a benefit.
It does not appear that the FDA is going to break their new rules!
So do we fight and fight and fight and possibly lose Marine since it really has "no proven benefit" in the FDA's eyes (see the label)?
We ALL want them to approve Vascepa in the meantime "knowing" it is safe and effective in bettering Lipid Panel Results.
I have been saying all along that Vascepa (I hope) will be approved for the 199 to 500 Class with the very same Language as Marine just as you suggested YET that may have worked before the "new and improved" FDA dug their feet in and allowed drugs go to market that are proven to be safe and effective.
They are questioning the Safety by discussing Internal Bleeding concerns, and they are questioning Effective because it has not been proven to do anything positive for people (in their minds)...
WE (and the FDA) all know it betters Lipid Panel results!
Yet that is not a "primary proven endpoint" (in their eyes) yet it should be...
This bring them back to: It does not Reduce CVE's!
SOOOOO - OK already... We agree! Approve Anchor with the very same exceptions as Marine on the label and lets move on!
NOTE: AMARIN IS SAYING THAT THEY ARE REQUESTING THIS FROM THE FDA.
I am HOPING that they approve it for just the (only) reason you noted: Reducing Trigs in the 199 to 500 class.
Anchor will not be approved as written with the CVE language...
I was hoping Amarin would ignore and accept the SPA rejection and move right into the Approval of Anchor with the Exceptions on the Label yet that is now on hold as Amarin wants to fight the rejection of the SPA...
The FDA agreed to treat the SPA and Anchor as completely separate actions. One down that at this point does NOT matter as long as the FDA allows Anchor soooo why not move on to a modified Anchor approval!?!
We are hoping it will be approved for a modified version of Anchor (as noted above) yet some of us want it all! The SPA and Anchor approved 100% as submitted!
NOTE: There are MANY people that want the old FDA back yet it does not appear that will happen. Vascepa is NOT the only company the FDA is pushing down this (new) road!
Biobillionair - Do you feel, think, or have any additional confidence that any of the Appeal Reviewers from your recently posted list offer any better chance for us than others on the list?
Hiding from Nutz! Shhhhhhhhh!
Nads: The FDA will approve Anchor with the following disclaimers:
Vascepa has not been tested nor has it been proven to Reduce CVE's...
In effect it will be approved to treat people with Trig's between 200 and 500 which is all Amarin's Joe Bruno said it is and was ever shooting for...
YOU ARE RIGHT: Anchor will NOT be approved to Reduce CVE's...
I spoke to Joe Bruno from Amarin who is their PR person at length just after the 16th of October because I wanted clarity as an Investor...
Why not give him a call Monday and take up a week or so of his time and ask him everything you are trying to "get across" here and then come back and give us an update to your position.
Here is his number: 1-908-719-1315
If it molds with Joe's then you are LONG. If it continues to not mold, then you must stay SHORT...
Or continue to HOLD your investment with an "80% chance of failure."
If that is the position you want to maintain, here is sound advise:
Sell now and go away, let the bad news hit, then re-buy and wait for Reduce-It.
In the meantime go to Joe for advise and please stop arguing with those here that know.
Our positions jive closely with Amarin's.
Anything else and you are just are just badgering people or you are certainly a closet short.
WHY ARGUE WITH US WHEN YOU SHOULD CALL JOE @ AMARIN and ARGUE WITH HIM?
He takes and returns ALL calls!
Nads: Here is a better way to look at it... From Seeking Alpha many months ago (before you ever heard about Vascepa:)
...and Dr Oz -(Nutz - Dr Oz has nothing to do with the Yellow Brick Road So PLEASE do not try to see a potential link there):
http://www.doctoroz.com/episode/fat-your-blood-doctors-never-talk-about
Bio: Noticed the pattern of the form links after I hit Post!