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I see that. Here is hoping for good news down the road
Especially if enough institutional investors tell him they ain’t voting for him.
Well, that didn't last too long.
Thanks for posting. The Fenofibrates would not be the only ones I would petition the FDA about. I know people will say they have no control over it, but if I sold a bottle of fish oil and told people that it will reduce CVD the FDA or FTC would come after me (if they had the resources, etc,) but in essence people who are getting Generic V or Lovaza and have been prescribed that for CVD are getting screwed because those drugs are not approved ( or even proved to be helpful) for CVD.
There is significant off label filling of people's scripts with Generic V for people who are taking it for CVD and Lovaza as well.
Have to agree with you Laurent. No other way to read the demeanor and thoughts of the 3 judges. Hopefully the trial judge is not pissed but follows their directives.
Maybe Amarin should get hackers to collate the data on V:
https://www.reuters.com/technology/cybersecurity/unitedhealth-says-hack-could-impact-data-substantial-proportion-americans-2024-04-22/
Ram, you are definitely correct about that. I believe that Kiwi though has mentioned easier things like some RWE that insurers might already have from people being on V for a number of years now.
All those statin studies were not done by one company. The FDA vigorously defended R-I at the Adcom, and although It is my opinion that there is sufficient corroborating evidence for V (Jelis, Respect?, Evaporate, etc) what is the point of a p value if studies have to be redone a myriad of times.
Your are making my point that if they were enamored with Gissi-Prevenzione, then they should over the top with R-I. Gissi was an open labelled study with no measurement of Omega-3 of participants. Many other facets too. No comparison to R-I.
Interesting that those EU countries reimbursed handsomely for Lovaza/Omacor, then stopped doing so and now with Vazkepa although not as effective at lowering trigs, nonetheless lowers trigs, doesn’t raise LDL, and have proof of reducing CVD (something Lovaza never has shown), they are so residtant to reimbursing. You would think they would be falling over themselves to cover V.
The only unfortunate thing is that they need to make an appeal to the Court of England???, and then wait for a decision and only then commence buying. They indicated almost another 2 months before they can start.
I was tempted to swap out my statin for the better tasting Oreos, but they are a bunch more expensive.
Joe, I am eating more of those homemade BLT sandwiches since I moved to the NW. To tie in with Nuke's question, there are a number of highly acclaimed restaurants around the Portland area - kind of a foodie town where people will wait in line for hours in the rain to get a table. Unfortunately for me, after a few visits, I'm broke. Expensive as hell compared to what I was used to in Florida. Take care of yourself.
Thanks. I was just looking at daily volumes. I mean the drug should work, but like you say will the Side effects be acceptable enough.
As Capt pointed out, EE forms of EPA are poorest at absorption, but it has to be stated that that comparison with other forms of EPA happens at a fasted state. When taken with fat the absorptions of the various forms of EPA become quite similar:
"Fasted State versus Fed State
An important finding in the majority of studies trying to understand the absorption behavior of omega-3 ethyl ester (EE) was that it is of utmost importance to take the omega-3-EE medication after a fatty meal (fed state) and not on empty stomach (fasted state). Unfortunately this fact is not detectable from the data shown in Table 2 because the Relative Bioavailability Index for the EE-form was always set to 100, even if the bioavailability with respect to absorbed absolute quantity of omega-3 (in mg) was very poor. A good illustration of this food effect can be seen in the absorption charts from the ECLIPSE study [18] where the bioavailability between an omega-3-ethyl ester drug (EE) and a omega-3-free-fatty-acid drug (FFA) was compared. The total EPA and DHA content of both drugs are comparable. From Figure 5a can be seen that the EE formulation (green line) in the fasted state (low fat diet) is only very poorly absorbed. Whereas the FFA form gets well absorbed with a typical Cmax at approx. 5 hours after intake. Taking the same formulations after a high fat diet (fed state) the absorption behavior of the EE improves dramatically and shows a similar curve-shape than the FFA-form (Figure 5b). However, looking at the total EPA+DHA plasma concentrations of the two charts (Y-Axis), it also becomes clear that the absolute quantity of absorbed EPA-FFA and DHA-FAA (in mmol/ml blood) improves almost twofold when the drug is taken after a fatty meal.
Therefore, in order to maximize the absolute quantity of EPA+DHA absorbed into the blood one should always ingest the omega-3 nutritional supplement or pharmaceutical drugs together or shortly after a fatty meal. Our digestive system, in particular the pancreatic enzymes and bile acids need to be triggered and released by a minimum amount of fat in our diet. This is especially important for the omega-3 EE form. Taking such a supplement or drug before or after a light breakfast (for example only fruit and coffee) will not release any pancreatic lipase that can split the EE into the absorbable FFA form. The majority of the ingested omega-3-EE will thus not be able to be absorbed and are lost with the feces. On the other hand, products offered as TG or rTG start to provoke a pancreatic response even in a fasted state and thus can be absorbed after being converted to the FFA and monoglyceride form. The efficiency of this “lipid digestion” can be even more improved by taking the TG/rTG omega-3 together with a fatty meal. In this case a maximum pancreatic lipase activity can be achieved which maximizes the efficiency of transforming EPA/DHA-rTG into the bioabsorbable FFA and MG esters. However, many people taking omega-3 products suffer from hyperlipidemia and thus should avoid a too fatty diet. In this case the omega-3 supplement/drug should be ideally in the FFA-, TG- or rTG-form.
As general rule can be said, that all EPA and/or DHA chemical forms are far better absorbed and thus more bioavailable, if taken together with or shortly after a fatty meal (Figure 6). Thus, bioavailability is directly influenced by (i) the chemical form of the omega-3 fatty acid and (ii) whether this omega-3 fatty acid was ingested in the fasted or fed state."
https://vitalremedymd.com/blogs/professionals/omega-3-bioavailability-dependson-the-chemical-form-concentration-and-fed-state
Also take it with some fat.
I think I see that higher volume if your avg volume is over the last 52 weeks, but it doesn’t look like higher volume compared to the last 3mo avg?? Am I looking correctly?
North this along with HSCS has taken a beating. Are they going kaput?
Well you used the word purify, which of course you need to do if you want to concentrate it.
Thanks for catching that and correcting the "huge". You discuss the need for separating from the glycerol in order to purify the EPA, but neglect to mention that the other reason is that it is almost impossible to significantly concentrate the EPA as long as the fatty acid is still bound to the glycerol. Good explanation on the purification.
You raise a good point about why the FDA has not gone after some of the supplement manufacturers. Of course the supplement manufacturers were selling omega-3 products long before any approved drugs came out, BUT although I am not sure, those products were confined to simply fish oil and were limited by the fact that they comprised no more than 18% EPA and 12% DHA. I remember after Lovaza was on the market that suddenly we began seeing higher concentration omega-3 products come on the supplement market. So I don't really know the timing of when supplement manufacturers started using the ethylated products - before or after FDA approval of Lovaza. But that timing might be an explanation as to why the FDA is not clamping down.
When the FDA checks the Generics for bioavailability, they are checking for EPA not the ethyl ester form. It is absorbed as EPA. Active moiety as Sleven said, but you seem to disregard this.
Think of say, the blood pressure drug, Metoprolol. It is available as Metoprolol tartrate and metoprolol succinate, with the succinate form having greater liposolubility.
https://pubmed.ncbi.nlm.nih.gov/20638827/
"The use of marine n-3 polyunsaturated fatty acids (n-3 PUFA) as supplements has prompted the development of concentrated formulations to overcome compliance problems. The present study compares three concentrated preparations - ethyl esters, free fatty acids and re-esterified triglycerides - with placebo oil in a double-blinded design, and with fish body oil and cod liver oil in single-blinded arms. Seventy-two volunteers were given approximately 3.3g of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) daily for 2 weeks. Increases in absolute amounts of EPA and DHA in fasting serum triglycerides, cholesterol esters and phospholipids were examined. Bioavailability of EPA+DHA from re-esterified triglycerides was superior (124%) compared with natural fish oil, whereas the bioavailability from ethyl esters was inferior (73%). Free fatty acid bioavailability (91%) did not differ significantly from natural triglycerides. The stereochemistry of fatty acid in acylglycerols did not influence the bioavailability of EPA and DHA."
I like your tenacity but I have to agree with Sleven on this. The reason for ethyl ester being in the patents, is that it is the way they can concentrate enough EPA to get 1,000mg into a swallowable pill, by detaching the EPA from the huge glycerol portion of the triglyceride molecule.
Zip, I think you summarize the situation pretty well. I mostly agree even with your comment about the buyback, with one caveat. Namely, if the buyback jogs the market into changing its negative view of Amarin and begin to realize the potential V and Amarin have, then it might be a good thing.
JRoon, congrats on the good numbers. I sold and myself used the Carlson EPA Elite Gems. Carlson has, in my mind, has a bit of a confusing product naming situation (too many products) in that their Gems can be a combo of EPA and DHA and their Elite EPA Gems only EPA.
And, they use the ethyl ester form in the Elite EPA Gems, which need to be taken with food to make sure they are well absorbed.
Thanks. Didn't need all that other stuff after ".......active EPA is triglyceride form."
"active" EPA and EPA that I get from a sardine are the same.
Sleven, I was asking about the distinction between EPA and active EPA based on this portion of Orbapu's post:
"Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine."
What is the difference in either molecular formula or chemical structure between EPA and "active" EPA?
One or the other.
Have a safe trip.
Thanks Sleven. I realize what remand means. It could mean a new trial, new sentencing hearing/order, a correction of the trial court’s order or other actions. I guess where I was confused is that it sounds like the Appeals Court cannot simply reverse the lower court's decision and rule for the other party.
What I was referring to is that there is very small chance that the Appellate court reverses the lower court decision. But barring that remanding back is the next best thing. We get another bite at the apple
Sleven, not as good as an outright overturn but a lot better than where we stand.
Well sure as to what you say. However, you also say: "...future sales and marketing campaigns". That of course is the major reason for the lack of growth, the stopping of all marketing. And, that was because of the entrance of Generics. Until you can shake the Generics not much can be done.
Thanks JRoon. I used to have a subscription when I was in the business, but have been retired now for more than 5 years. They were rather superficial with what they tested for. Our biggest gripe was that they didn't test every product on the market and it seemed willy nilly as to what they selected to test. For instance, many times the best seller or the product with the best reputation was not tested. But it did have some value to us.
Interesting mention of Icosapent Ethyl. I am sure this is based on the Evaporate trial by Dr. Budoff. What caught my eye was the comment that it was only shown to reduce plaque in those with trigs above 150. So I did look up the Evaporate study and sure enough the median trig level was over 250. Of course this doesn't mean it couldn't help someone with lower trigs but just not proven in a trial:
Well stated.
Overall market has taken a drubbing the last few days and volume here is small so not Amarin specific. Steady as she goes. I am like the Dread Pirate Roberts, taking iocaine powder over time so I am now immune.
I think to Kiwi’s list I would add that curtailment of advertising, salespeople, etc can go a long way explaining the small market.
Do you know how to translate the 7693kg into dollar value to compare the quantity to what Amarin already has on hand?
Don’t see any news —- anyone know the reason for this morning’s drop?
Thanks Capt. Do you know what Vascepa's percentage of the market was before R-I results? Curious to know if it was even the 10% being bantered about as a supposed total portion of the O3 market.
For me, if GV was ONLY being prescribed for very high trigs (>500) I would think it should be even far less than that because Lovaza (GL) is far better at dropping trigs (I realize at the expense of raising LDL - but it is only supposed to be used for a very short time so I believe docs would make that tradeoff)