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Regulation FD. If word had got out that he had material information and hadn't shared it, he and Amarin would have been sued. I am not sure why you keep bringing this up over and over.
Full and fair disclosure of material information is the law. Whether it fell under the 8-k 3 day rule doesn't matter. He did the right thing for shareholders and you know it.
More BS here, suggesting that a positive post must be AMRN management . Your post should definitely be looked at as suspect.
They lightened the load on their top six holdings. It doesn't appear to be personal.
"So what would happen on PDUFA date? " Nothing, the FDA would miss their deadline, as they should, if this is their fault.
They have not moved it, they have not finalized it as Nov 14th so all is speculation. Keep in mind, there is no such thing as booked up as there are different locations and different committees. It will just depend on if they can get the committee together.
Look up reasons the FDA would do a three month delay in PDUFA date. The FDA only cites two reasons that I can find. Either there would need to be a manufacturing issue causing a delay or a major amendments.
Neither of those may apply in this case. It appears that it may just be that the FDA failed to schedule the AdCom when they should have. If that is the case the FDA will not move the PDUFA date. They will hold the Adcom and then work to finish the approval process.
The FDA misses PDUFA's all of the time. Their goal is 90%. The rest of this is malarky.
If the reason for the delay is because the FDA failed to schedule the AdCom appropriately, the PDUFA date will not change. The PDUFA date is a guideline that the FDA will fail to meet.
This is what Webbush said but confirmed, probably not by them. I'm just countering the random website someone posted this morning that is also not confirmed.
From a twitter post today. Wedbush:" Upcoming PDUFAs, FDA Panels : 9/12 $ARDX, 9/13 $AIMT , 9/28 $AMRN , 10/07 $PFNX, 10/19 $CLSD and $ALXN, 10/20 $FOMX, 10/21 $ETON, 10/30 $AGRX, 11/09 $LPCN, 11/14 $FOLD/PFE, 11/16 $AGRX, 11/30 $AQST ..."
You were pretty sure of yourself with your post that they will try. Now you have gone from a will to s could. That is my point, that it is not something that is definitely going to happen and in my assessment, not very likely at this point in the patent life cycle and with the new patents being granted.
Who are the others that will try? Why haven't they filed yet? What are they waiting for? Anchor and Reduce it patents in the orange book?
North, I can't respond to you in a private message. I should not have said Reduce-it Patents. I should have said results from Reduce-It trials. John Thero said at the BMO conference that "The court has allowed us to introduce the results of the REDUCE-IT study, which we think supports the uniqueness of Vascepa." I think that is a benefit.
I am no expert on it but I believe so, out of Japan in some cases.
The Amarin team is definitely in Paris. I do not believe they have a typical sales/Reps booth there because they do not have a product on the market in Europe but there presence is definitely being felt. Dr Bhatt/ Dr Mason et all presentation is this afternoon.
High level of EPA is associated with lower perivascular coronary attenuation as measured by coronary CTA
SESSION Poster Session 7
SPEAKER Daniel Bittner
Congress : ESC Congress 2019
Topic : Imaging
Sub-topic : Coronary CT Angiography
Session type : Poster Session
FP Number : P6164
Authors : D O Bittner (Erlangen,DE), M Goeller (Erlangen,DE), Y Zopf (Erlangen,DE), S Achenbach (Erlangen,DE), M Marwan (Erlangen,DE)
D O Bittner1 , M Goeller1 , Y Zopf1 , S Achenbach1 , M Marwan1 , 1University of Erlangen-Nuremberg (Friedrich-Alexander-University) - Erlangen - Germany ,
Citation:
Introduction: Pericoronary adipose tissue (PCAT) composition has been recently shown to be a potential novel marker of coronary inflammation with higher PCAT attenuation shown to indicate increased cardiac mortality. Polyunsaturated fatty acids (PUFAs), especially Omega-3 fatty acids (n3), are thought to alter inflammatory response and intake of high dose Eicosapentaenoic acid (EPA, C20_5 n3) was shown to decrease mortality, however exact pathophysiological mechanisms are unclear. Therefore, we sought to determine whether blood levels of PUFAs are associated with differences in pericoronary fat attenuation.
Methods: In 64 symptomatic patients with intermediate pretest-likelihood for coronary artery disease presenting with atypical angina, coronary CTA was performed. PCAT attenuation was measured in Hounsfield Units (HU) around the proximal 40mm of the right coronary artery (RCA) using semi-automated software. Erythrocyte membrane fatty acid composition (in percentage) was analyzed with a standardized analytical methodology, displaying a variety of fatty acids including n-3 fatty acids using gas chromatography.
Results: Patients were divided into two groups (each n=32) using the median PCAT attenuation of -78.1 Hounsfield units (HU), resulting in one group with low (-95.58 to -78.17 HU) and one with high (-78.06 to -62.92 HU) PCAT attenuation. Among both groups, no differences were seen in age, sex, BMI, traditional cardiovascular risk factors or the number of cardiovascular risk factors (all p>0.05). In univariate analysis, significantly higher values of EPA (1.00% [0.78; 1.26] vs. 0.78 % [0.63; 0.99]; p=0.02) were seen in patients with lower PCAT attenuation. All other fatty acids showed no significant differences (all p >0.05). Moreover, a significant negative correlation was seen between PCAT attenuation and EPA (Pearson correlation coefficient -0.38; p=0.002), but not for age, sex, BMI or number of cardiovascular risk factors (all p>0.1). Multivariable linear regression analysis confirmed this association and showed a significant inverse association of EPA to PCAT attenuation (ß=-0.31, p=0.017), independent of age, gender, BMI and number of CV risk factors (all p>0.1).
Conclusion: High levels of EPA are associated with lower PCAT attenuation on coronary CTA indicating different composition of pericoronary adipose tissue potentially caused by a lesser degree of coronary inflammation.
Increase in EPA/AA Ratio Predicts Improvement in Endothelial Function in Purified Eicosapentaenoic Acid-Treated Patients
Presentation tomorrow
SESSION Poster Session 7
SPEAKER Kazuo Fukumoto
Congress : ESC Congress 2019
Topic : Preventive Cardiology
Sub-topic : Lipids: Drug therapy
Session type : Poster Session
FP Number : P6205
Authors : K Fukumoto (Osaka,JP), Y Takemoto (Osaka,JP), J Yoshikawa (Osaka,JP), N Norioka (Osaka,JP), T Iguchi (Osaka,JP), M Yoshiyama (Osaka,JP), T Shuto (Osaka,JP)
K Fukumoto1 , Y Takemoto1 , J Yoshikawa1 , N Norioka2 , T Iguchi3 , M Yoshiyama2 , T Shuto1 , 1Osaka City University Graduate School of Medicine, Department of Medical Education and General Practice - Osaka - Japan , 2Osaka City University Graduate School of Medicine, Department of Cardiovascular Medicine - Osaka - Japan , 3Bell land General Hospital, Department of Cardiovascular Medicine - Osaka - Japan ,
Citation:
Background: Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are well-known for preventing cardiovascular disease. Among n-3 PUFAs, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) play key roles in preventing cardiovascular diseases. However, the effects of n-3 PUFAs have been examined under conditions of simultaneous administration of EPA and DHA in the majority of clinical investigations and the effect of purified EPA is still controversial. EPA has been reported to improve endothelial dysfunction. Although several mechanisms underlying the effects of EPA on endothelial function have been demonstrated such as the modulation of lipid metabolism including increases in high-density lipoprotein (HDL) and/or decreases in triglyceride (TG) levels, decreases in cytokine production, and inhibition of inflammatory processes, the main mechanisms ameliorating endothelial function have not been fully determined.
Purpose: We sought to clarify the main factors associated with EPA administration that led to improved endothelial function.
Methods: Fifty-one consecutive patients with hypertriglyceridemia (mean ± SD age, 60 ± 13 years) with no evidence of coronary artery disease (CAD) were prospectively enrolled and administered purified EPA (1800 mg/day). Forty-eight patients who were not administered EPA were enrolled as age- and sex-matched controls. Clinical variables such as body mass index, HbA1c, fasting glucose level, HDL, low-density lipoprotein, TG, systolic blood pressure, diastolic blood pressure, heart rate, interleukin-6, baseline diameter of the brachial artery, intima-media thickness of the brachial artery, and flow-mediated dilation (FMD) were examined before and after 6 months of treatment. Univariate and multivariate regression analyses were performed to examine the associations between FMD changes and clinical variables.
Results: FMD was significantly improved from 4.16% ± 1.88% to 6.30% ± 2.24% (p < 0.0001) in the EPA group. The change in FMD was positively correlated with the change in EPA/arachidonic acid (AA) ratio (r = 0.34, p = 0.014). The multivariate regression analysis showed that the change in EPA/AA ratio alone was significantly associated with the change in FMD (p = 0.010).
Conclusions: EPA treatment improves endothelial dysfunction in patients with hypertriglyceridemia without evidence of CAD. The change in FMD was associated with the change in EPA/AA ratio alone. These finding suggest that a direct effect of EPA on the endothelium may be the predominant factor ameliorating endothelial function.
Eicosapentaenoic acid therapy is associated with decreased coronary plaque instability assessed using optical frequency domain imaging
SESSION Poster Session 6
SPEAKER Takao Konishi
One of the presentations tomorrow - Congress : ESC Congress 2019
Topic : Cardiovascular Pharmacology
Sub-topic : Lipid-Lowering Agents
Session type : Poster Session
FP Number : P5366
Authors : T Konishi (Sapporo,JP)
T Konishi1 , 1Hokkaido University - Sapporo - Japan ,
Citation:
Background: The relationship between eicosapentaenoic acid (EPA) therapy and coronary plaque stability assessed by optical frequency domain imaging (OFDI) has not been thoroughly described.
Hypothesis: EPA therapy is associated with decreased plaque instability in patients undergoing percutaneous coronary intervention (PCI) using OFDI.
Methods: Data on coronary artery plaques from 121 patients presenting with acute coronary syndrome or stable angina who consecutively underwent PCI between October 2015 and July 2018 were retrospectively analyzed. Of these patients, 109 were untreated (no-EPA group), whereas 12 were treated with EPA (EPA group). Each plaque’s morphological characteristics were analyzed using OFDI.
Results: We used 1:4 propensity score matching for patients who received or did not receive EPA therapy before PCI. Baseline characteristics were balanced between both groups (age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, chronic kidney disease, smoking, previous PCI or coronary artery bypass grafting, previous myocardial infarction, prior statin use, acute coronary syndrome, hemoglobin A1c level, low-density lipoprotein cholesterol concentration, triglyceride concentration, and high-density lipoprotein cholesterol concentration). The EPA group had significantly lower mean lipid index (818±806 vs. 1,574±891) and macrophage grade (13.5±5.9 vs. 19.3±7.4) but higher mean minimum fibrous cap thickness (109.2±55.7 vs. 81.6±36.4 µm) than the no-EPA group (P=0.010, 0.019, and 0.040, respectively). Multiple logistic regression analyses showed that prior EPA use was independently associated with lower lipid index and macrophage grade (P=0.043 and 0.024, respectively).
Conclusion: This OFDI analysis suggests that EPA therapy is associated with decreased plaque instability in patients undergoing PCI.
The omega-3 fatty acid eicosapentaenoic acid (EPA) is inversely associated with ischemic brain infarcts in elderly patients with atrial fibrillation
One of the presentations today
Congress : ESC Congress 2019
SESSION Poster Session 4
SPEAKER Martin Franz Reiner
Congress : ESC Congress 2019
Topic : Aortic Disease, Peripheral Vascular Disease, Stroke
Sub-topic : Stroke - Prevention
Session type : Poster Session
FP Number : P3712
Authors : MF Reiner (Zurich,CH), P Baumgartner (Baden,CH), A Wiencierz (Basel,CH), S Aeschbacher (Basel,CH), N Rodondi (Bern,CH), O Baretella (Bern,CH), M Kuehne (Basel,CH), G Moschovitis (Lugano,CH), LH Bonati (Basel,CH), C Von Schacky (Munich,DE), TF Luescher (London,GB), GG Camici (Zurich,CH), S Osswald (Basel,CH), D Conen (Ontario,CA), JH Beer (Baden,CH)
Abstract
Slides
Video
Report
Abstract
Authors:
MF Reiner1 , P Baumgartner2 , A Wiencierz3 , S Aeschbacher4 , N Rodondi5 , O Baretella6 , M Kuehne4 , G Moschovitis7 , LH Bonati8 , C Von Schacky9 , TF Luescher10 , GG Camici11 , S Osswald4 , D Conen12 , JH Beer2 , 1University Hospital Zurich - Zurich - Switzerland , 2Cantonal Hospital of Baden, Internal Medicine - Baden - Switzerland , 3University Hospital Basel, Clinical Trial Unit - Basel - Switzerland , 4University Hospital Basel, Department of Cardiology - Basel - Switzerland , 5Bern University Hospital, Internal Medicine - Bern - Switzerland , 6Bern University Hospital, Institute of Primary Health Care - Bern - Switzerland , 7Lugano Regional Hospital, Division of Cardiology - Lugano - Switzerland , 8University Hospital Basel, Department of Neurology and Stroke - Basel - Switzerland , 9Ludwig-Maximilians University, Department of Preventive Cardiology - Munich - Germany , 10Imperial College London - London - United Kingdom of Great Britain & Northern Ireland , 11University of Zurich, Center for Molecular Cardiology - Zurich - Switzerland , 12Mcmaster University - Ontario - Canada ,
Citation:
Background
The association of individual omega-3 fatty acids (n-3 FAs) with ischemic stroke remains unclear. Experimental data strongly suggest that n-3 FAs reduce ischemic stroke due to their anti-thrombotic and anti-inflammatory properties. Yet, recent clinical trials yielded mixed results. While marine n-3 FA supplementation (1g/day) did not reduce stroke, icosapent ethyl, a purified eicosapentaenoic acid (EPA) ethyl ester (4g/day), significantly reduced stroke incidence in patients at high cardiovascular risk. In the current study, we examined the association of fish-derived EPA, docosapentaenoic acid (DPA), docosahexaenoic acid (DHA) and the plant-derived alpha-linolenic acid (ALA) with the prevalence of ischemic brain infarcts in elderly patients with atrial fibrillation.
Methods
In this cross-sectional analysis of the Swiss atrial fibrillation (swissAF) cohort study, we determined baseline whole blood n-3 FAs by gas chromatography according to the HS-Omega-3 Index methodology in 1665 patients aged = 65 years with atrial fibrillation. Large non-cortical and cortical infarcts (LNCCI) were assessed by brain MRI. Total and individual n-3 FAs were correlated with the prevalence of LNCCI in a logit model with continuous factors. Analyses were adjusted for sex, age, body mass index, smoking, alcohol intake, family history of cardiovascular disease and atrial fibrillation, physical activity, hypertension, diabetes, chronic kidney disease, prior stroke, prior transient ischemic attack, aspirin, anticoagulation and type of atrial fibrillation.
Results
A total of 373 patients with LNCCI (22.4%) were identified. After adjustment, lower risk of LNCCI was associated with higher EPA (odds ratio [OR] 0.50 per increase of one percentage point EPA, 95% confidence interval [CI] 0.28 – 0.88) and a higher risk was detected with DPA (OR 2.39, 95% CI 1.43 – 4.01). No statistically significant association was detected with DHA (OR 1.13, 95% CI 0.94 – 1.35), ALA (OR 0.83, 95% CI 0.23 – 2.95) or total n-3 FAs (OR 1.03, 95% CI 0.92 – 1.16).
Conclusions
Higher levels of EPA are associated with a lower prevalence of ischemic infarcts in aged patients with atrial fibrillation. Unexpectedly, DPA shows a direct correlation with ischemic infarcts. This study demonstrates that individual n-3 FAs may differentially affect stroke risk and that supplementation of EPA may be an interesting strategy to prevent ischemic stroke in atrial fibrillation patients.
With New lipid guidelines from the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) “We recommend measuring triglycerides, and based on REDUCE-IT trial it is reasonable to use high-dose EPA (icosapent ethyl) in high-risk patients with TG levels between 1.5-5.6 mmol/L (135-499 mg/dL)” FDA is looking like they are behind the curve.
You are just presenting GENERICS view.
"The GENERICS are pinning their whole case on this particular area and its up to AMARIN'S legal team to refute "WRITTEN DESCRIPTION" in their patents.."
How can they pin their whole case on "WRITTEN DESCRPTION" when their expert witnesses were not able to discuss WRITTEN DESCRIPTION".
From the way I am reading it the GENERICS are trying to convince the judge to be able to use "WRITTEN DESCRIPTION" in their arguments because they failed to have any of their expert witnesses address "WRITTEN DESCRIPTION" during their pre-trial expert witness testimony.
West-ward is now Hikma. Hikma and Dr Reddy are the GENERICS being discussed. What is being discussed is being blown out of proportion because it is not the whole argument, it is not the whole trial. It is some small back and forth being discussed prior to potential trial. Amarin is trying to limit Hikma/Dr Reddy's arguments thet can be discussed at trial because they did not bring expert witnesses to discuss certain aspects of patent litigation. What is being discussed is only GENERICS response. I believe Amarin will get to respond to this in two weeks. It has nothing to do with what would happen if this actually goes to trial. It is pre-trial motions. It is noise at this point.
They would have to invalidate all of the claims sited in all of the patents in the lawsuit, not just a couple of them. You do not need to worry unless you think that can happen. Once you got that nailed down remember that by the time this would go to trial many of the reduce-it patents will be included.
So the GENERICS expert witnesses knew nothing about written descriptions in their testimony and could not discuss anything about it but now want to use it to try and invalidate some of the claims??
Thank you for checking, hopefully someone else will see this who has access.
TDAmeritrade list option by option detail throughout the day as it occurs in their ThinkorSwim platform.
From the documents included with the VA funding of the alzheimers trial
"the omega-3 fatty acid eicosapentaenoic acid (EPA) improves arterial function and cerebral blood flow, attenuates adverse brain changes related to ?-amyloid protein"
CalMustang, thank you so much for doing this. This is great. Can you also combine 252-254?
EPA clears the arteries so improves blood flow to the brain.
I just asked an attorney and got the same response. This will just be an opportunity for each party to respond to the other parties request for partial summary judgement and summary judgement. Both documents will probably be late in the day Nevada time.
You are likely to get rained out of your golf tomorrow.
Current Jefferies note courtesy of Dough on twitter
dough
@semodough
·
1h
$AMRN short-term, scripts for Vascepa continue to demonstrate double digit Q/Q growth of 10-15% or $120M in Q3, which is above current consensus of $110M.
dough
@semodough
· 1h
Jeff $AMRN Scripts continue to grow every week despite no label change and we think 2020 numbers are too low; we are positive but fully acknowledge investors remain nervous into a panel presumably in Nov.
From Yee " In terms of patent litigation, a court date is set for Jan 2020....we think if any settlement comes, stock moves quickly higher towards $25+."
This is holding the stock down whether you like it or, whether threat is real or not.
Analyst believe some investors think this, not the analyst themselves.
Analyst have stated that it is a risk and uncertainty for some investors. Until the risk is mitigated with a settlement some will find it a reason not to buy. I am not sure how many are in this camp but I would like to find out soon.
Since reduce-it results were announced Amarin has been trading in a range between 14 and 23 and with all that short interest is likely headed right back to 23.
Volume has dropped way off. At the current volume it would take far longer than 4 days to cover.