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Good point about the PVR's. I would be good, IMO, with spreading out the tax consequences of a buyout over many future years.
My post is a quote from the 10-k, if it is difficult to read for you, you might want to take it up with management. I don't know as much about it as you but I thought it read pretty easily.
From 10-K The indication we intend to seek based on the final positive results of REDUCE-IT pertains to use of Vascepa to reduce cardiovascular events in at-risk patients. While the current FDA approved indication for Vascepa is biomarker based (i.e., lowering triglyceride levels), the indication we will seek based on REDUCE-IT results will be outcomes based (i.e., lowering cardiovascular events).
It is believed that the effects of EPA are not due to a single mode of action, such as triglyceride lowering, but rather to multiple mechanisms working together. Studies in the scientific literature explore potentially beneficial effects of EPA on multiple atherosclerosis processes, including endothelial function, oxidative stress, foam cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture. With respect to triglyceride levels, our scientific rationale for the REDUCE-IT study was supported by (i) epidemiological data that suggests elevated triglyceride levels correlate with increased cardiovascular disease risk, (ii) genetic data that suggests triglyceride and/or triglyceride-rich lipoproteins (as well as low-density lipoprotein cholesterol (LDL cholesterol), known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data that suggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. The REDUCE-IT study was designed to determine the clinical benefit, if any, of stable EPA therapy in statin-treated patients with elevated triglyceride levels.
This is brutal language for future competition. From 10-k Based on prior communications from the FDA, including communications in connection with its review of the ANCHOR indication for Vascepa, it is our understanding that the FDA is not prepared to approve any therapy for treatment of cardiovascular risk based on biomarker modification without outcomes study data, with the potential exception of therapies which lower LDL-cholesterol. In particular, it is our understanding that the FDA is not prepared to approve any therapy based on data demonstrating lowering of triglyceride levels. In our view, this position from the FDA is unlikely to change based on the REDUCE-IT study particularly in light of the independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of Vascepa are unique to Vascepa and extend beyond triglyceride reduction. If the FDA were to change this position, it could potentially have a negative impact on Amarin by making it easier for other products to achieve a cardiovascular risk reduction indication without the need in advance to conduct a long and expensive cardiovascular outcomes study.
From the 10-k On February 22, 2019, a purported investor in our publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, our chief executive officer and chief scientific officer in the U.S. District Court for the District of New Jersey, Debendra Sharma v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 2:19-cv-06601 (D.N.J. Feb. 22, 2019). The lawsuit alleges that, during the period September 24, 2018 and November 9, 2018, we misled investors by purportedly not disclosing that the placebo given to patients in the REDUCE-IT study, mineral oil, may have caused cardiovascular problems in the patients taking it, thereby misleading investors on the outcome of the REDUCE-IT study and artificially inflating the price of our securities. Based on these allegations, the suit asserts claims under the Securities Exchange Act of 1934 and seeks unspecified monetary damages and attorneys’ fees and costs. We believe that we have valid defenses and we will vigorously defend against the claims, but cannot predict the outcome of this lawsuit. We are unable to reasonably estimate the loss exposure, if any, associated with the claims. We have insurance coverage that is anticipated to cover any significant loss exposure that may arise from this action after payment by us of the associated deductible obligation under such insurance coverage.
When Reps call on hospitals they are probably calling on the institution. They are calling on the on-site pharmacies and the management that runs them. Drugs have to reside on the shelves for physicians who order the drugs for their patients. There is usually a review committee that would try to monitor appropriate usage of a drug. Cost containment obviously being one issue but also appropriate use of care. A hospital pharmacy would be the gatekeeper but appropriate use of prescription medication should be a pretty easy case for Vascepa.
If a hospital only has generic Lovaza, after Reduce-it results, any physician could easily make a case to the committee/pharmacy management to bring in Vascepa. Sales reps trained in hospital pharmacy operations would/could assist in this process.
Check out twitter, search for #NLAportland to see what was being said last night about the various sessions where reduce-it results were being highlighted. You can also search for reduce-it, vascepa, or icosapent ethyl to also see other posts.
I should not be giving medical advice but from personal experience, you may want to look into taking some CO-Q-10 with the statin. The muscle pain hit me in my elbows. A few months after starting on statins, I was told I had golfers and tennis elbow. 400mg each day seems to be the sweet spot for me. 200mg was not quite enough. I am currently golfing twice a week and going to the gym twice a week with muscles feeling great. I do stretch a lot.
I have not kept up with the complete thread but you may want to approach the benefits administrator at this guys place of employment if he is employed. You would not need to initially be specific with who the patient is but get them to understand that they have a patient that is a heart attack waiting to happen and CVS is pulling this.
I had this occur one time over a year ago. I reported it to Vascepa.com personnel and they had me take the bottle back to the pharmacy and the pharmacy (after two days) swapped it out for a new bottle.
I do understand the infatuation with Baker Brothers but there were plenty of other organizations buying 2 Million in shares in the 4th quarter.
CLEARBRIDGE INVESTMENTS, LLC 3,704,232 $60,268,000 0.05 290 3,703,706 1.1471% 13F 2018-09-30 2018-11-14
PRICE T ROWE ASSOCIATES INC 6,526,794 $106,191,000 0.02 0.00 654 3,514,595 2.0212% 13F 2018-09-30 2018-11-14
PARALLAX VOLATILITY ADVISERS, L.P. 2,962,895 $48,206,000 0.06 145 2,962,895 0.9175% 13F 2018-09-30 2018-11-14
POINT72 ASSET MANAGEMENT, L.P. 2,605,299 $42,388,000 0.17 162 2,605,299 0.8068% 13F 2018-09-30 2018-11-14
BARCLAYS PLC(CALL) 2,203,200 $35,846,000 0.02 0.00 557 2,182,200 13F 2018-09-30 2018-11-14
STATE STREET CORP 2,241,609 $30,488,000 0.00 0.00 1687 2,085,978 0.6942% 13F 2018-12-31 2019-02-12
Jefferies Group LLC(CALL) 2,050,000 $33,354,000 0.22 69 2,050,000 13F 2018-09-30 2018-11-14
Jefferies Group LLC 2,033,513 $33,085,000 0.22 72 2,033,513 0.6297%
I asked for my refill of Vascepa on Friday and it was available finally today. Initially, they only had a partial refill. Good news, the 30 day supply cost my $30 less than last year. My January refill was basically the same price for for February things are looking up for my out of pocket.
Time frames for 13F and 13G filings are different. Believe it or not, you can both be right, it just depends on the dates you are looking at. 13F filings are for the end of the quarters where 13G are done whenever there is a material change for large holders of a stock. The dates on the 13G filings can be more current than the quarterly filings.
You do realize that the Baker Bros were already invested when AMRN was already going it alone. They have been going it alone for several years with Baker Bros invested.
Vascepa was reviewed under this committee in the past. I would be interested in the boards thoughts on who will review the new sNDA.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm096416.htm
Why don't you start with the current panel instead of this nonsense and go from there.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm094747.htm
Not from that article but more detail...
“. We reaffirm our OW rating and $35 12-month price target. On 1/4/19 AMC, AMRN provided a business update, including a preliminary estimate of 2018 revenues as well as 2019 revenue and spending guidance. The sentiment from investors post the financial update from AMRN has been negative given that 2019 sales guidance came in below expectations, but we think the Street should focus more on the peak sales potential of Vascepa than on near-term sales, which are hard to forecast, given several moving parts (timing of increased sales promotion, potential DTC campaign, label expansion, EU partnership, etc.). One good comp for Vascepa is Jardiance.”
Wait, is this you, starting a rumor, about why the rumor existed?
I am seeing maximum pain for next Friday at 21.
The whole market dropped in the last 30 minutes. XBI, IBB included. The dump at the end of the day was not about AMRN. Typical response from this message board. No one ever seems to look at anything else going on.
His delivery is much improved.
Dr Bhatt tweeting NEJM video
@DLBHATTMD
21m21 minutes ago
More
Dr. Deepak L. Bhatt Retweeted NEJM
Fantastic video summary of the REDUCE-IT trial by @NEJM - they really know how to make data easy to digest! @DLBHATTMD @gabrielsteg @mmillermd1 @JWatch @NEJMres360
Dr. Deepak L. Bhatt added,
@NEJM
New Quick Take video: Reducing Risk in Hypertriglyceridemia https://nej.md/2GNDBod
https://www.nejm.org/do/10.1056/NEJMdo005434/full/
The fly usually has really good information. Companies meet with analyst all the time. It is probably nothing, but it may be something.
You are right. It is fine as long as Medicare Part D is not paying. The regulation is to prevent manufacturer's coupons from inducing the purchase of drugs paid for by Part D.
Just to see what I found, I went to wikipedia and searched for Icosapent ethyl. It referred me to this page. https://en.wikipedia.org/wiki/Ethyl_eicosapentaenoic_acid It looks like it could use some updating for Reduce-it if anyone has the expertise to make it happen.
There are documents that go back to March on this decision when a referral was made to review omega 3s. Scroll down this page for the details.
https://www.ema.europa.eu/en/medicines/human/referrals/omega-3-fatty-acid-medicines
BCBS plans and PBMs vary across the country so your statement that Catamaran is BCBS's PBM is not accurate. You would need to more specific on what BCBS plan uses Catamaran.
Could someone respond to this, there are room for comments -
https://www.consumerlab.com/answers/fish-oil-supplements-vs-prescription-fish-oil-vascepa/fish-oil-supplements-vascepa/
You can see the formulary online for CVS Caremark for the "next quarter" and there does not appear to be any changes.
No, probably not, but once there is an actual approved drug for the lower triglyceride indication, insurance companies should be required to cover it. With further differentiation and only drug for indication insurance companies will need to allow access to the drug.
I would imagine one of the next journal articles to come out about Vascepa Reduce-it will be a cost savings peer reviewed article. It will be sponsored by Amarin and will be part of the FDA sNDA package and can also be used to approach insurance companies and government agencies.
Lovaza will never have the indication for triglycerides < 500. There will be no insurance companies that require Generic Lovaza first.
This is a good list. Thank you for taking the time to write it. I would add, do not try this over the phone or through email. Coming in prepared and in person will get better results.
What do you mean by lack of efficacy in diabetic patients?
In many cases it is not the doctors, it is the insurance plans and the pharmacists. Prior Authorizations will require generic lovaza first based on the old logic that it was probably almost as good. Many of those generic lovaza script may have also been in the Medicaid populations.
This is where Amarin Managed Care department with the new data needs to come in. I am sure if they have not already they will be sending packages with new data to insurance carriers. Of course, many will stall until FDA approval.
"Generic Lovaza should be black boxed for dialysis patients and Vascepa should be ON LABEL for this population" One suggestion - After this statement, can you add detail as to why Generic Lovaza should be black boxed for dialysis patients.
Amazing that this was there for all to see and yet many out there thought reduce-it would fail.
Darn, I was so looking forward to the Corn Oil Placebo story for the Strength trial.
Their last filing is for 40 million shares. They are required to file any material changes. Do you really think there are over 400 million shares outstanding?
Sam, It has been posted before but there is so much nonsense on this board, it doesn't hurt to see it again.