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i a at 65 ldl atorvastin 10 mg, and vascepa
also from the study, A decrease in consumption of processed or unprocessed red meat of at least half a serving per day was not associated with mortality risk.
so doing what you have been doing is apparently ok
Its taking the component of canola that is good, which is the omega 3 oils and then purifying it, just like we process crude fish oil. You would be taking out the bad oils to get to the good ones, just like crude fish oil when we get rid of the dha, and get the epa.
Crude fish oil doesn't have to be the only source. Why not buy this omega 3 oil and then purify it to obtain the epa? Plant based sources will continue to increase.
FDA Concludes Nutriterra® Total Omega-3 Food and Feed Safety Evaluation
Global News, Homepage, Nuseed Canola, Nuseed Omega-3 / By dlemoine
WHAT DOES THIS MEAN?
The FDA’s New Plant Variety consultation is a voluntary, yet rigorous, evaluation of safety and regulatory compliance. Nuseed Nutritional consulted with the Food and Drug Administration (FDA) for a comprehensive safety, nutritional and regulatory assessment of Nuseed Omega-3 Canola, including using Nutriterra® in food markets.
We collect a lot of data in creating a new-to-the-world source of total omega-3 nutrition. Our safety evaluations included tests for allergens, pesticides, toxins, and other contaminants you wouldn’t want in your food. We analysed environmental impact and performed animal feeding trials and human clinical trials. Nutriterra undergoes multiple quality and content tests every time we turn seed grain into oil.
We voluntarily submitted over 350 pages of data and more than 100 references to support our assertions that Nutriterra is safe for use in food and delivers increased omega-3 over conventional canola. At the conclusion of the review, the FDA issued a letter that they have no further safety, regulatory or compliance questions.
DOES THIS MEAN NUTRITERRA IS FDA APPROVED?
The result of this consultation is that Nutriterra does not require FDA approval. FDA’s letter acknowledges our conclusion that its use in food is Generally Recognized As Safe (GRAS) and does not raise issues that would require premarket review or approval by FDA.
WHY DOES NUTRITERRA NEED TO BE EVALUATED FOR SAFETY?
The New Plant Variety Consultation is a voluntary premarket review. While there is no requirement, we value the insights and expertise of the FDA in evaluating the safety and legality of foods produced from new plant varieties. We pursued this consultation because Nuseed Omega-3 canola is distinctly different from conventional canola. It offers increased omega-3s and improves the ratio of omega-6 to omega-3 (from 2:1 to 1:4) when compared to conventional varieties. Derived from Nuseed Omega-3 Canola, Nutriterra Total Omega-3 oil provides seven omega-3 polyunsaturated fatty acids including DHA, EPA, and ALA.
While we are confident in our products, the additional FDA scrutiny provides assurance to our customers that including NUtriterra in their formulations will not present any safety or regulatory challenges.
This validation means US food manufacturers can confidently use Nutriterra as a plant-based alternative to marine oils for these essential nutrients.
DOES THE WORLD NEED A NEW OMEGA-3?
Fewer than 20%* of US consumers are meeting the daily recommended intake of omega-3. Our proprietary research indicates that taste, tolerability, and dietary preference lead objections to fish oils. Moreover, many consumers prefer functional food to meet their nutritional needs. Nutriterra’s mild taste ensures ease of formulation.
The FDA’s affirmation reinforces the importance of our plant-based innovation and supports our advancement into functional food. By providing a good source of omega-3 nutrition, Nutriterra can attract new consumers and help more people meet their dietary requirements through everyday food and drinks.
OTHER REGULATORY ADVANCEMENTS
Nuseed previously obtained human food and animal feed approvals in Australia, New Zealand, and Canada and is progressing with additional regulatory applications in other key markets around the world. Last year the FDA recognized Nutriterra as a New Dietary ingredient. Plant based is a rapidly growing omega-3 category, and Nutriterra provides a safe and effective alternative to marine oils for food or supplementation.
sorry, i mistyped the VLDL it was 25 in 2022 while on Vascepa, 57 in 2023 while off, and back to 26 in 2024 on Vascepa. Also they were fasting numbers, and no drinking of alcohol.
Lipid panel on Vascepa, off Vascepa, and back on . I am one of those low hdl, high ldl, high triglycerides individual. Been on Vascepa a number of years, but last year was requested by surgeon to go off of it prior to ankle surgery due to his concern and clinic policy for bleeding risk. Surgery date was delayed due to scheduling problems so was off of it for 5-6 weeks. Tested and then retested again this year. No other medication changes Atorvastin and vascepa medications . My primary doc and cardiologists are believers !
2022 2023 2024
Total Cholesterol 140 183 135
LDL 72 87 65
HDL 44 39 44
VLDL 25 26 57
TG 140 350 154
When selling a new drug, you don't signal a loss of confidence in your research, the results, or the product by doing another trial. If you show weakness in your convictions and product, it will only create further doubt in the minds of the people you are trying to convince. When selling, conviction, persistence must prevail.
So you ever been involved with any research in your career? You think researchers only work to get grants? The professionals I have had the opportunity to work with over the years are dedicated to ensuring that their findings are accurate, repeatable and their funding depends on that criteria. As a group they seek out answers, and if a study fails in one aspect it may present a clearer route to discovery going forward. An additional thought, you may want to consider that this disease touches alot of people either directly or indirectly, and to even think researchers would not have a keen interest in trying to reduce its severity and presence is a statement you may want to reconsider.
Because a VP would simply tell you he/she is not privy to any information on an ongoing trial until results are released. Plain and simple, and damn sure they wont waste an hour with you. This topic contained no new information. It was hey, look over there in the woods, I think I saw Bigfoot, where, there, go waste your time looking for him.
so unsubstantiated bs. The Springer document clearly lays out the data points of the trial members being measured , so we all know where the baseline data is.
and if you look elsewhere in the document they allude to the number of hits made when Final results are released, so they are not going to willy nilly let the data out without proper notice and release of the factual data. This has a profound impact on future research, so the UW will be careful, precise, and unbiased.
This information should also be sent to state attorney offices as they may want to render opinion on behalf of their consumers
the German study was taking blood profiles to see if there were relationships, Brave uses a treatment of epa. Just like we all saw in Reduce-It the dose is key.
if the apoe 4 carriers dont respond then it confirms that subset wont benefit, and any further trials would make that an exclusion.
FCS is estimated to impact 1-2 people per million worldwide. The trial was specific to that and successful. In addition to FCS, Ionis is evaluating olezarsen for the treatment of severe hypertriglyceridemia (SHTG) in Phase 3 clinical trials, so it would be awhile before that approval would come through.
In the first nationally representative study(link is external and opens in a new window) of cognitive impairment prevalence in more than 20 years, Columbia University researchers have found almost 10% of U.S. adults ages 65 and older have dementia, while another 22% have mild cognitive impairment.Oct 24, 2022
One in 10 Older Americans Has Dementia
Columbia University Irving Medical Center
tHE COGNITIVE TEST BEING USED IN BRAVE is sensitive to early indicators of the disease before it would be apparent. This was developed so that trials could be run as preventative rather than treatments.
the cognitive test APCC
Conclusions
The APCC is an empirically derived composite cognitive test score with high face validity that is sensitive to preclinical AD decline up to 11?years prior to diagnosis of the clinical stages of AD. The components of the APCC are supported by theoretical understanding of cognitive decline that occurs during preclinical AD. The APCC was used as a primary outcome in the API Generation Program trials.
U.S Veteran eligible for VA care.
Age 50-75 years, inclusive. Cognitively healthy.
With increased risk for developing AD due to parental history of the disease and increased prevalence of APOE4 allele.c
from patent application--covers the why would u want it in one dose
TECHNICAL PROBLEMS
[0012] There is a demand for a pharmaceutical composition containing a ?3 PUFA and a statin, wherein administration
at a single dose is enough.
[0013] There is also a demand for a pharmaceutical composition having a daily dose of the statin incorporated with a
daily dose of the ?3 PUFA.
[0014] There is also a demand for a transparent pharmaceutical composition having a daily dose of the statin incorporated with a daily dose of the ?3 PUFA.
[0015] There is also a demand for a pharmaceutical composition wherein the ?3 PUFA and the statin in the preparation
are kept stable.
[0016] There is also a demand for a pharmaceutical composition wherein the composition has excellent self-emulsifying
property of the ?3 PUFA in the preparation, dispersibility of the composition, and emulsion stability.
[0017] There is also a demand for a pharmaceutical composition wherein the ?3 PUFA and the statin in the preparation
exhibit excellent releasability in the digestive tract upon administration.
[0018] There is also a demand for a pharmaceutical composition wherein the ?3 PUFA and the statin in the preparation
exhibit excellent absorption property upon administration.
[0019] There is also a demand for a pharmaceutical composition which exhibits a pharmaceutical effect equivalent to
the case of combined administration of separate preparations each solely containing its medicinal component although
at least one medicinal component is used at a low dose.
[0020] There is also a demand for a pharmaceutical composition wherein side effects are smaller compared to the
case of combined administration of the preparations each solely containing its medicinal component.
[0021] There is also a demand for a pharmaceutical composition whose administration is easier due to the reduced
volume compared to the case of combined administration of the preparations each solely containing its medicinal component.
[0022] There is also a demand for a pharmaceutical composition with higher medication adherence compared to the
case of combined administration of the preparations each solely containing its medicinal component.
[0023] There is also a demand for a preparation wherein amounts of ethanol and polyhydric alcohol in the preparation
has been reduced.
[0024] There is also a demand for a pharmaceutical composition wherein denaturing as represented by cloudiness
or separation of the pharmaceutical composition is not recognized even when stored in a low temperature or high
temperature environment.
[0025] There is also a demand for a pharmaceutical composition wherein softening of a capsule film has been suppressed so that the pharmaceutical composition is not deformed when encapsulated.
[0026] Accordingly, an object of the present invention is to provide a pharmaceutical composition wherein at least one
of such properties as described above has been improved as well as a preparation having such pharmaceutical composition encapsulated therein.
[0027] Another object of the present invention is to provide a pharmaceutical composition wherein at least one of such
properties as described above has been improved as well as a
ADVANTAGEOUS EFFECTS OF INVENTION
[0039] The pharmaceutical composition of the present invention is a pharmaceutical composition containing a daily
dose of EPA-E and a daily dose of pitavastatin, rosuvastatin, or a salt thereof, and accordingly, administration at a single
daily dose is enough. The pharmaceutical composition of the present invention contains a small amount of water instead
of ethanol and polyhydric alcohol in the pharmaceutical composition. Compatibility of the pharmaceutical composition
is improved by such composition, and the amount of the emulsifier used can also be reduced, and safety for animals
(including human) is thereby improved. In addition, the EPA-E will be included at a higher content, and this enables
reduction in the amount of emulsifier used, and compliance is thereby improved.
[0040] Inclusion of the water in the pharmaceutical composition also enables a composition without or with a minimized
content of the ethanol or the polyhydric alcohol, and the capsule film is prevented from softening, and deformation of
the capsule does not occur.
[0041] The pharmaceutical composition of the present invention is excellent in at least one of compatibility (appearance), self-emulsifying property, dispersibility of the composition, emulsion stability, and absorbability, and even when
administered before the meal or after ingestion of a low-fat diet, is rapidly absorbed to suppress increase in the serum
TG after the meal, or when administered before going to bed, prevents essential fatty acid deficiency upon administration
of a lipase inhibitor.
[0042] The pharmaceutical composition of the present invention is excellent in at least one of solubility, stability in the
preparation, releasability in the digestive tract, and absorption from the digestive tract of pitavastatin, rosuvastatin, or a
salt thereof.
[0043] Further, the composition as described above enables not only the storage at room temperature but also the
storage under the conditions of low temperature (for example, 5°C) and high temperature (for example, 40°C) without
causing separation or cloudiness of the pharmaceutical composition, namely, with good appearance.
[0044] The pharmaceutical composition of the present invention has at least one, preferably at least 2, and more
preferably all of the preferable features as described above
COMBO would create testing opportunity i have been on statin for 14 years and every year i have to get blood test to check for liver enzymes and routinely whatever doctor or insurance have ordered the usual chol tests, sugar triglycerides etc. As a user of Vascepa i think it would be great to have a combo pill and have drs annually run omega 3 blood test to check key epa level and ratios. that would show patient and dr progress.
actually he says in the video he is going thru a ton a week. by the bag he is probably paying 400 to 500 dollars a ton, so a couple grand per month
epa dha the beauty of reduce it trial is the fact that we only controlled the variable of adding epa and not subtracting dha. in most real life situations diet remains relatively the same as its hard to change dietary habits. so by adding epa we were able to overcome higher dha than desired. the epa dha ratio improved without having to change the denominator.
They must have radio silence, they cannot disclose it, its a research trial!!! They cannot disclose any information until the trial is completed and the study is complete.
Those who started in Dec 2020 were completed in DEC 2021. If they said well 90 percent of them are still on it, most people would assume it works. Even if the data show that those on for 20 months had less its not included in the study data,,its quite simple 0- 12 months.
Now after the study is completed, and they wish to release follow-up data, then yes they can and yes its good to know, but it has no bearing on the success or failure of the drug in the trial.
If they see the pattern later, then they would need to submit a new trial for a longer period.
re Mitigate,, I don't understand why you think a year and half is needed, that is not what this study is designed for. It is designed for one year of taking vascepa vs those who did not within 0 TO 12 MONTHS. So they take people that were not any Omega 3s , not had covid 19 and see if there is any benefit to preventing COVID-19, influenza, and other known viral respiratory pathogens.
And if they did get it was there a benefit to the reduction in the bad stuff. They are not running a mini-Reduce it Trial, they are really wanting to know if you received Vascepa, did you get sick and if you did, did you fare better than those that did not.
Primary Outcome Measures :
Rate of confirmed viral URIs [ Time Frame: 0-12 months ]
Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities)
Secondary Outcome Measures :
Percentage of patients with moderate or severe confirmed viral URIs [ Time Frame: 0-12 months ]
Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation <94% on room air and/or requiring any form of supplemental oxygen.
Worst clinical status due to a confirmed viral URI [ Time Frame: 0-12 months ]
At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)
Other Outcome Measures:
Percentage of participants who die due to any cause [ Time Frame: 0-12 months ]
Percentage of participants experiencing a major adverse cardiovascular event [ Time Frame: 0-12 months ]
Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke
Percentage of participants experiencing an expanded major adverse cardiovascular event [ Time Frame: 0-12 months ]
Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)
Percentage of participants who are hospitalized for heart failure [ Time Frame: 0-12 months ]
Percentage of participants who are hospitalized for any reason [ Time Frame: 0-12 months ]
Percentage of participants who have an emergency department visit for any reason [ Time Frame: 0-12 months ]
date tot cholesterol LDL HDL TRIGLYCERIDES
1-17-2005 258 178 37 217 BEGAN LIPITOR NEXT DAY 10 MG
10-24-2005 200 94 39 334
02-05-2008 204 104 39 421
03-23-2012 178 104 44 148
05-10-2018 170 101 39 298 BEGAN VASCEPA IN AUG 2018 4 GM
02-28-2019 182 70 35 385 IN ADDITION TO THE LIPITOR
10-13-2020 130 75 41 68
05-03-2022 141 72 44 140
OTHER NOTICABLE CHGS REDUCED SWELLING IN DAMAGED KNEE JOINT
All this Mitigate vs reduce it data is clouding the issue. Help me here, but isnt the issue does Vascepa treatment (which occurs after the diagnosis of Covid) reduce death, and AVSCD events vs those not taking it? Period. We are treating people who have been stressed with a life changing disease. Lets see if a proven medication can do anything to help these patients. Period. You can't disprove prior research with a different set of defining criteria. Ie.. Whoops we better not give aspirin because it didnt do anything to help covid therefore never use aspirin again.
TOP 5 EXPORTING NATIONS IN 2019 PERU, DENMARK, US, CHINA, NORWAY CHILE
They will argue it, because a win on that point wins it all.
Do your interests differ from that of Amarin itself? No.
My fear is that the judge says our interests were already represented and we do not get another shot to argue our points.
Has anyone heard from JL
Shareholders are the corporation for all things legal. The appeal was filed by Amarin and the legal firms hired were our representation. That is the why the court is going to interpet this issue.
I have read all of your explanations and wish you would win, but the only hope is to attack the representation as inadequate. This is the way a person charged with a crime appeals to the court that the lawyer failed miserably in procedure or actions to make his representation mute.
You must address the fact that the Board did not join the rule 60 because they and their legal team would be admitting incompetence. Incompetence is why we the shareholders have not had adequate representation and thus have standing.
$ 8.75 ,a share,, by the way I recall guessing an end of the year 2021 price. do you still have those predictions? I think my guess was one of the lowest and not too far from current price
My take is the opposite. He liked the tweet because it represents the sentiment of many, and he is going to love it when He presents the data, and your guess is proven wrong. Just a polite way of poking at your guess.
Worried avout compliance tp trial protocl? use a test that proves a direct measure. take the epa level of the blood. thats all you need
They are winning the argument in my opinion. Here is my rebuttal strategy. its timely because all litigation and evidence was not 4.5 ears but was less than 1 year once the wrong table was made public. just like a murder trial that might show new dna evidence long after other testimony, the wrong table trumps all evidence.
2 the parties interest is not different. Well shareholders are people who invest money in multiple stocks, and the truthful presentation of data is important to their investing futures beyond just Amarin. They cannot allow the judicial system to overlook the truthful and accurate presentation of facts.
our interest is not adequately protected and our interrst is impeded as we are not party to the proceedings and do not see the display of evidence and oral argument until after the fact.
4. our interest is not presented by others as Amarin itself did not support us in this motion and was it aware of the deception occurring.
A possible marker for determining effectiveness of AD treatments without conducting long long term studies? Would a control vs a treatment group comparing this marker in a set time period give results faster? not fast enough for vascepa but interesting
https://www.alzforum.org/news/research-news/can-single-amyloid-pet-scan-predict-time-symptom-onset
Read the dissenting opinion. It points out the weakness of the majority opinion in a clear fashion, and expounds upon what is not inducement.
1, If I understand our argument we are saying the label is evidence of inducement because it points out the Afib warning which was not part of the high trig label. Yet the generics are required to include safety warnings and since the high trig dose of 4 gm per day is the same as our cvd indication why is that inducement?
2. It is reasonable to expect there will be infringement in some amount, that is not causation. Remember out original roll out was for the high trig market, so there does exist a substantial amount of patients that were under that use. I think we are estimating 9 percent of the population overall, but of those started on vascepa before cvd indication must be quite large?
3. The minority opined about the GSK-Teva decision being so weak that it was specifically pointed out by majority that this was case-specific and not meant to change broadly the intent of Hatch Waxman. Her last statement about the ubiquitous substitution by pharmacies, is that a hint she thinks there is where there is room to legally discover and establish decisions?
Bingo! Maybe over a cocktail a sales person from Amarin and one from Pfizer came up with the idea and floated it past their managers during one of those "goal setting" session. This keeps them busy and keeps relationships intact while Pfizer is probably considering acquiring a company with new medications in the pipeline and by having this arrangement it buys some time for those trials to complete. And also gives them a look see at Amarin.
Why doubt the accuracy of the trial based off of those concerns? For one thing these are patients receiving the medication from their provider, not people reporting a supposed usage. Secondly the data is what it is, if they were healthy their triglycerides change primarily due to diet and energy balance. Perhaps The secret to EPA may be related to force production in the diaphram as discussed in those research trials listed on Amarin investor site.
His statement is entirely neutral and free of any speculation. He starts it out with an IF. And ends it with an obvious statement.
They don't know as per ;
With regard to investigator-initiated clinical studies, which are clinical studies conducted by third-parties with the support of companies like Amarin, the clinical results often are not made available to the company during the conduct of the study. For example, Amarin has supported multiple investigator-initiated trials (IITs) pertaining to the potential use of VASCEPA® to help prevent COVID-19 infections and/or help mitigate the severity of such infections. These COVID-19 pilot studies have been separately described by Amarin [click here for FAQ]. Such IITs are conducted by leading healthcare professionals and research organizations using product (VASCEPA) supplied by Amarin. In these IITs, where Amarin is not the sponsor, the data collection, analysis and overall conduct of the studies are done independently of Amarin, and Amarin is blinded to the ongoing study results.
A DILUTION OF 430M DIV BY 5.6 N SHARES EQUALS 7.7 PERCETN OR JUST $3.50 PER SHARE. Of course they would be happy to acquire a growth opportunity for such a small investment
much much later ( 5 mths)I got the vaccine after I read research that your antibodies would be roughly 10x better w vaccine vs natural immunity.
I am on Vascepa and did have Covid, but without any apparent symptoms. I discovered I had it by testing positive for the antibodies when I went to give plasma. I can only remember one time when I felt extremely tired for a day, but thats it. I did also get the vaccine months later.