Authorized generic is still prescription, not over the counter. Would not be on displayed on a shelf.

You’re welcome. Best of luck to your friend.

He’s doing well, 3 years. Still on Vascepa.

My brother’s case was quite serious because the 6 blockages were 90% and too extensive to be a candidate for bypass and his cardiologist concluded it was too severe for stents as well. The Chief Cardiologist made a judgment call to go ahead with the procedure and it was successful.

That was 3 years ago and he is doing well, still taking Vascepa.

Both cardiologists were proponents of Vascepa.

Bismarck, ND. Go figure!

The old bleeding canard.

My brother got 6 stents. Simultaneous catheterizations, groin and arm, two cardiologists. On Vascepa before, during, and after. Procedure included Atherectomy on some blockages plus use of impella pump.

I had double hernia surgery, the old way, not robotic. On Vascepa. And yes, I disclosed pre surgery medications. No bruising and rapid recovery.

Heading into the daily fade.

I believe Amarin started distancing their messaging from fish oil when they discerned it was cheapening the brand. That horse isn’t going back in the barn. The damage has been done. Not that there is anything inherently wrong with fish, but the supplement industry owns that space and they are fiercely defending it.

Economics is the reason EPA is sourced from fish. It could be sourced from algae (that’s where the fish get it) but at this time fish are the most economical option.

The idea Amarin can achieve marketing success by differentiating their “fish oil” as extra special is seriously doomed. The supplement industry would bury them. Moreover, Vascepa is not fish oil anyway and basing your marketing on a lie is unethical.

Another name for active EPA is triglyceride form. EPA needs to be converted to ethyl ester form in order to be concentrated to the levels found in Vascepa. When de-esterfied in the small intestine, it reverts to triglyceride form so it can be absorbed.

High purity EPA supplements like OmegaVia EPA 500 have to be esterfied in order to achieve the required purity and then converted back to triglyceride form for encapsulation. Hard to get accurate data, but their so-called “pure EPA” has about 10% DHA.

I’m a renaissance man.

Projection?

You pretty much nailed it.

“Pompous “…Well, as an engineer I’ve been called worse. That whole thing of using facts and data to make conclusions gets folks going sometimes.

I’m disappointed in Dr. Bhatt’s confusing and wrong conflation of fish oil and IPE. Is this so hard to remember and recite?

“Icosapent ethyl or ethyl eicosapentaenoic acid is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA).”

Initially, I think Amarin sought to demystify Vascepa by associating it with fish oil, something the public could relate to rather than scientific mumbo jumbo. It backfired because now the public, doctors and scientists just see Vascepa as some sort of amped up albeit very expensive fish oil.

That is a false equivalence. IPE does not occur in nature. Chewing on a fish will not provide the benefit of Vascepa.

So your solution is to lie?
“What the company needs to do is accept that everyone thinks it's fish oil and convince everyone that it is, in fact, the KING of fish oils”

Vascepa is not fish oil, purified or otherwise. Vascepa is Icosapent Ethyl, a derivative of the chemical molecule Eicosapentanoic Acid (EPA), one of the omega 3 polyunsaturated fatty acids. EPA is found in fish oil, algae, and certain plants. Ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate is a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol. Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine. It reaches peak plasma concentration in 5 hours post-oral administration. Very little (<1%) is left circulating in the plasma as EPA incorporates into phospholipids, TG's, and cholesterol esters. Vascepa is 96% or higher purity Icosapent Ethyl. Icosapent ethyl does not occur in nature. Vascepa is not fish oil, it’s not concentrated fish oil, it’s not distilled fish oil, it’s not highly purified fish oil, it’s not single barrel fish oil, it’s not double oak fish oil.

Early on, Amarin tacitly if not actively allowed and promoted associating Vascepa and fish. A colossal error and one that is impossible to recover from. There is a reason doctors who should know better tell patients to take fish oil pills rather than prescribe Vascepa, “it’s the same thing”. So tell me, is Lovaza, a useless drug that continues to greatly outsell Vascepa associated with fish oil? Not so much me thinks.

Agree. We will need to be satisfied with accumulation of evidence over time from the real world. There’s this thing called a business case.

A valuable focus of research would be pleiotropic benefits, looking at cancer and inflammatory illness differences between groups.

I guess if BRAVE shows some indication of possible benefit, then we could see larger studies, probably government funded.

You are welcome.

I worked much of my career on flight critical hardware for human rated spacecraft, namely Space Shuttle. The mindset was very much on what possibly could go wrong. Both Challenger and Columbia were a result of cognitive bias. You might find Diane Vaughan’s book on the Challenger of interest.

https://en.wikipedia.org/wiki/Diane_Vaughan

You have been calling for RWE research on Vascepa for some time. Now when an actual study pops up you’re pretty dismissive. Sure, it has limitations but generally good news with positive implications. It is especially interesting to get these results with the “placebo” being probably Lovaza.

I recovered my original investment in Amarin when the stock was above $15. Just waiting now.

You are the Sultan of Snark for sure. Take a look at the cognitive bias codex. Next we will find out the participants were not on a statin. Get the smelling salts!
https://en.wikipedia.org/wiki/Cognitive_bias

All this self flagellation victim stuff over the judge is a waste of energy. A good legal team (not one like Amarin had):

1) Assumes the opposing council is awesomely strong

2) Assumes the judge is:
)Stupid
)Partisan liberal
)Partisan conservative
)Lazy
)Poorly educated in the area being litigated
)Conspiracy theorist
)Belligerent bully
)Arrogant
)Weak of character and being led around by the nose by the clerks
)Dishonest
)Etc.

Amarin’s team was overconfident, inept, and lazy. They likely would have lost even in front of a good judge.

As I posted earlier, everyone currently has plausible deniability. If the specific indication is on the label, that goes away.

As such, generics will fight to their last breath to prevent any such thing. Insurance companies, PBM’s, pharmacies, and doctors will join them!

As of now, insurers have plausible deniability. Specific label instructions would remove that.

I sure hope you are right! Certainly 5% and then 10% rise must have popped up on a lot of watch lists.

Yes, it is much different and I wouldn’t be surprised if the SP sinks back tomorrow as people have time to digest the situation and rationally assess the great deal of uncertainty that lies ahead. Right now all we have are possibilities that are impossible to quantify.

Volume lately has been around 1M. We are 4M now. Somebody might be paying attention?

Another collection of geniuses. IPE didn’t even get an honorable mention.

Curious about the timing. They could have filed this anytime. Why now?

They (the study researchers) just keep beating the same dead horse. What am I arguing?
1) 5 years later and heart disease continues to be the leading cause of death and getting worse. Hmmm,.
2) The study didn’t include the people with “normal” ldl who died. That continues today. I challenge you to find any data on victims with “normal” labs. Not a popular topic with researchers.
3) Drs still base their treatment protocols on optimal and near optimal guidelines. (100-129). That means people keep dying from heart attacks.
4) Even with ldl that meets your ridiculous standards that only a few nerd cardiologists like Bhatt try to achieve, people still will suffer from atherosclerosis.
5) Test protocols for CVD risks are pretty much only exercised when people have symptoms. Like when having a heart attack. Or an autopsy.
Said with a heavy accent in a menacing tone of voice:
“My name is Dr Corpuscle. Your labs are normal. Prepare to die!”

First of all, nearly half of the people in the study had optimal ldl of less than 100.

Second, these are the current national guidelines for ldl:

https://www.nhlbi.nih.gov/files/docs/guidelines/atglance.pdf

Yes, there are some organizations recommending <70 or even <55. However, doc’s generally likely won’t do much for people in even the nearly optimal range. And they certainly aren’t going to run additional tests like Lp(a), oxidized ldl, or ldl particle size/count or CAC scans.

That’s how “healthy” people in their 40”s and 50’s end up dead from atherosclerosis they had no idea they had.

So, diet then?

5 years ago:

A new national study has shown that nearly 75 percent of patients hospitalized for a heart attack had cholesterol levels that would indicate they were not at high risk for a cardiovascular event, based on current national cholesterol guidelines.

https://www.uclahealth.org/news/most-heart-attack-patients-cholesterol-levels-did-not-indicate-cardiac-risk

The medical establishment’s fixation on ldl rather than getting to root cause is why heart disease continues to be the leading cause of death.

MarketEdge: Most TA indicators still are bearish.

As of 03/26/2024 - Avoid the stock.
Stock is Not a Short Sale Candidate.
If you are Long; close position or monitor stock closely.

On 03/26/2024, The stock has underperformed the market when compared to the S&P 500 over the last 50 trading days. Over the last 50 trading sessions, there has been more volume on down days than on up days, indicating that AMRN is under distribution, which is a bearish condition. The stock is trading below a falling 50-day moving average which confirms the weak technical condition of AMRN. In addition, AMRN is below its falling 200-day moving average.

Resistance Range: 0.88-0.90
Support Range: 0.83-0.85

Negative OBV is bullish: Negative OBV relates a decrease in volume to the change in the stock’s price. When volume decreases from the previous day, the N-OBV is adjusted by the percentage of change in the stock’s price. The N-OBV only changes on days when volume decreases and is displayed as either bullish (BL) or bearish (BR), depending whether today’s volume figure is over or under its 24 day moving average

MF Slope is bullish: The MF (Money Flow) Slope identifies the direction in which the MF is pointed. Although the raw MF value is a valuable overbought/oversold indicator, it is the direction or Slope of the indicator that forewarns of a change of trend in a stock’s price

My wife had her Lp(a) checked last year (functional medicine dr). 16 nmo/L or 6.4 mg/dL. Been on Vascepa for a few years.

I find it interesting that the commentary on Lp(a) notes that it is a risk factor and cannot be improved by diet and exercise. Yet it is well known that diet and exercise is probably the most effective thing you can do to lower heart disease risk.

Here’s some educational material for your cardiologist. Do you know your Lp(a)? I inferred from this Amgen infomercial that drs don’t measure Lp(a) because there is no pill to fix it. To paraphrase a quote from The Princess Bride, "My name is Dr Corpuscle. Your Lp(a) is high. Prepare to die."

https://www.amgen.com/stories/2023/02/8-things-to-know-about-lipoproteina

Disagree.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4439182/

It’s not “some cognitive measures…” it’s a specific test.

“cognitive performance [Time Frame: 18 months]
Preclinical Alzheimer's Cognitive Composite (PACC)”

If there is any measurable divergence (in favor of IPE) at all in any of the 3 parameters, I will consider it to be important. I have a younger sibling who has been in a nursing home the past 9 years with early onset Alzheimer’s.

This:

“The study was purely about bio markers.”

This statement is from BRAVE detailed description:

“The proposed study aims to: 1) investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow as measured by arterial spin-labeling MRI; 2) determine the impact of 18 months of IPE vs. placebo on CSF biomarkers of AD pathology; and 3) evaluate the effects of 18 months of IPE vs. placebo on cognitive performance.”

It’s not hard to find and saves you from substituting your opinion for fact in this public space.

Amarin gets a delisting war in 22 days. Actual delisting is 6 months or 1 year.

MarketEdge: All indicators have turned bearish. Expecting another downgrade to “Avoid” soon.

As of 03/11/2024 - Stock shows Strongly Deteriorating Conditions. SCORE = -3
If you are Long, consider closing position or monitor stock closely.

On 03/11/2024, The stock is underperforming the market when compared to the S&P 500 over the last 50 trading days. The MACD-LT is indicating that the intermediate-term trend is bearish at this time. If the stock closes below $0.63 a change in trend will be confirmed.Upside momentum, as measured by the 9-day RSI, is negative. The stock is in a short-term oversold condition based on a Slow % K stochastic reading of 20 or lower. Over the last 50 trading sessions, there has been more volume on down days than on up days, indicating that AMRN is under distribution, which is a bearish condition. The stock is trading below a falling 50-day moving average which confirms the deteriorating technical condition of AMRN. In addition, AMRN is below its declining 200-day moving average.

Resistance Range: 0.95-0.97
Support Range: 0.83-0.85

MarketEdge: Downgrade today from Long to Neutral

As of 03/08/2024 - Stock shows Mildly Deteriorating Conditions. SCORE = -2
If you are Long, hold current position. Do not initiate new position.
Stock is Not a Short Sale Candidate.

On 03/08/2024, The stock is underperforming the market when compared to the S&P 500 over the last 50 trading days. The MACD-LT, an intermediate-term trend indicator, is bearish at this time. If the stock closes below $0.63 a change in trend will be confirmed.Upside momentum, as measured by the 9-day RSI, is negative. The stock is in a short-term oversold condition based on a Slow % K stochastic reading of 20 or lower. Over the last 50 trading sessions, there has been more volume on down days than on up days, indicating that AMRN is under distribution, which is a bearish condition. The 50-day moving average is pointed up but the stock is trading below this important support level which is bearish. In addition, AMRN is below its declining 200-day moving average.

Resistance Range: 0.96-0.98
Support Range: 0.91-0.92