The role of genius is not to complicate the simple, but to simplify the complicated.
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so many unlicensed territories.
1. sell EU, mostly upfront cash and smaller royalty
2. use cash from #1 for DTC in US while lawsuit(s) are pending
3. use licensing fees from new territories to pay dividends
if MARINE labeling represents ~5%? of vascepa revenues, how about this?
amarin settles with generics by paying a royalty to generics based upon vascepa Rx's written for triglyercide-lowering effect for patients with trigs over 500 for 12 weeks from Rx start. after 12 weeks, the indication is automatically considered to transition from MARINE indication to REDUCE-IT indication.
instead of paying generics some enormous upfront settlement, let them partake in vascepa's ongoing success, but in a mutually agreed fashion.
vascepa, as so many here have said prior to this patent disaster, is destined to be one of the highest selling drugs of all time.
generics need only determine how to split the royalty revenue amongst themselves.
from. JDUR
I didn't see any replies to this post. I believe the content deserves recognition and scrutiny. the message posting rate has become ridiculous.
JDUR's post:
"Defendants filed ANDAs including Paragraph IV Certifications based on Plaintiffs’
drug Vascepa. (See, e.g., ECF No. 1 at 1-6.) ANDAs must include the proposed labelling
that will accompany the generic drug—and that labelling must generally be substantially
the same as the labelling that accompanies the brand-name drug. See AstraZeneca, 633
F.3d at 1045-46. Here, Defendants’ proposed labelling is materially indistinguishable from
Plaintiffs’ labelling. (ECF Nos. 252 at 15, 245 (sealed).) Defendants also did not seek to
omit anything from Plaintiffs’ labelling. (ECF No. 252 at 15.)"
The label has now changed with additional uses by the FDA and for the drug to be ANDA, the labels have to be substantially similar. This is another win for AMRN. The FDA may not approve an ANDA since a substantially similar label cannot be achieved without infringing on the patents.
"If that is too difficult to answer, as you would have to get into their minds, perhaps an easier question is how many physicians, a decade ago, recommended that their patients take EPA? Is the answer similar to the P value of REDUCE-IT's primary endpoint? "
in Japan, or elsewhere, he snarked?
"If they dilute right now, the next shareholder vote will absolutely go against them."
are your speaking for all the shareholders? the longer term, high cost basis stuckholders? and/or the recent buyers whose cost basis is in the $4-5 vicinity?
interested in Mori himself?
Trevor Anthony Mori
University of Western Australia | UWA · Medical School
Doctor of Philosophy
https://research-repository.uwa.edu.au/en/persons/trevor-mori
Mori is a Research Professor and NH&MRC Senior Research Fellow in the School of Medicine and Pharmacology at the University of Western Australia. He is a medical research scientist with an interest in nutrition, hypertension, atherosclerosis and cardiovascular disease. His research interestsinclude omega-3 fatty acids in preventing cardiovascular disease; the role of lipid oxidation in atherosclerosis and cardiovascular disease; fatty acid metabolism; resolvins and protectins; platelet and leukocyte function; and control mechanisms in blood pressure regulation. His research has been supported by the US National Institutes of Health, the National Health and Medical Research Council of Australia, the National Heart Foundation of Australia and the Australian Research Council. He has published more than 250 papers and has established numerous international and national research collaborations
https://www.nutraingredients-omega3summit.com/professor-trevor-mori/
The heart of the matter. Are omega-3 fatty acids beneficial in the prevention of cardiovascular disease? (including REDUCE-IT)
https://www.nutraingredients-omega3summit.com/wp-content/uploads/2019/02/Trevor-Mori.pdf
https://www.semanticscholar.org/author/Trevor-Anthony-Mori/34874726
https://www.researchgate.net/profile/Trevor_Mori
https://www.ahajournals.org/action/doSearch?ContribAuthorStored=Mori%2C+Trevor+A
https://www.biomol.com/dateien/Cayman--Dietary-Fatty-Acids.pdf
"just say the word"
I dont believe it works that way. limited power of attorney and all to grant rights to a willing proxy who would change the terms of a sales contract with a broker.
do we know he has not? if the form 4 has an indicator for that event, I am unaware as I don't recall ever having seen such an indication.
agreed the optics are awful. however, if I were one of the pre-planned sellers, based upon the turn of events these week, recalling the existence of a pre arranged sale and cancelling it rapidly, would not have occurred to me. especially with the rabid onslaught of shareholder emails clamoring for either my resignation or my contingency plans.
best golfer on the course often cannot win a driving distance contest.
be precise, how many biotech patent trials has she sat?
board moderators cannot accomplish what you ask. admins can.
"be clear and convincing"
to some one practiced in the art, correct?
not clearly convincing to the judge herself
mind boggling
so here we are again with an option-like priced stock, much like pre reduce-it results. except the timing of the next share price impacting binary event is unknown.
the higher cost basis of 10s of millions of shares being reset down here in the $4s. creating over head resistance all over again.
are there too many shares outstanding for a company of this new, lower sales potential?
do amrn shares have more appeal with 100M shares outstanding than with current ~400M?
I wonder too much.
Further study is needed to assess whether people with relatively large body mass might be safely and effectively treated with higher than 4 g/day of icosapent ethyl.
oh, there's a sales revenue accelerator if ever there was one.
might not have been thero's intent, but in my reading of those two words, "capsule franchise" it is implied there is some franchise other than vascepa or some formulation other than capsule.
or, perhaps I am merely too tired from thinking outside the box for the past 6+ hours.
Amarin Corporation plc (NASDAQ:AMRN) today commented on the United States District Court for the District of Nevada’s ruling in favor of the generic companies in the company’s patent litigation against two filers of abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA® (icosapent ethyl) capsule franchise.
"capsule franchise"?
what gives there?
franchise, ok.
but why "capsule"?
why were those two words added when the sentence could have ended at "(icosapent ethyl)" with no change in understanding?
odd and unnecessary, but why?
running out of posts.
how do ANCHOR AND AMR-102 play in this fight?
remove MARINE language from label, add ANCHOR language in its place.
https://investor.amarincorp.com/news-releases/news-release-details/amarin-announces-positive-results-phase-1-clinical-trial
Judge Du
wonder why she became an attorney as opposed to a physician or scientist?
why are you expending effort dashing other peoples' hopes? have you lost the ability to have your own hopes? don't you hope your wife does not get infected in service to her patients, for instance? hope is a good thing. allow others to lose it at their own pace.
“Following the approval of icosapent ethyl as an adjunct to maximally tolerated statin therapy for a broad range of patients at risk for cardiovascular disease, a common question from physicians has been, what is the mechanism behind the large reductions in cardiovascular events such as heart attacks and strokes seen in REDUCE-IT?” commented Deepak L. Bhatt, M.D., M.P.H., lead investigator of the REDUCE-IT trial. “Now we see that the benefits appear to be driven primarily by on-treatment EPA levels with icosapent ethyl, whereas changes in triglycerides levels and other cardiovascular risk markers, including LDL, HDL, apoB and CRP, appear to be responsible for a significantly lesser proportion of the overall observed benefits.”
MARINE label
could amarin seek that FDA remove the MARINE trial language and indication entirely from the vascepa label based upon this understanding of MOA, I.e., not changes in triglyceride levels but rather on-treatment EPA levels?
"She relied on a “hypothetical patient” in Mori with Tg> 500 to conclude that Epa was shown to reduce TG and not raise LDL in pts. She states Mori had pts in the Tg> 500 group (even if it was one) and that’s enough to say it was obvious and that the results would not be limited to just the Tg< 500 group. You and I both know a three arm trial of 20 pts each with maybe 1 having TG>500 is not scientific evidence. I can’t put into words how I feel after reading this brief. I hate to say it but I can’t conclude anything else other than she was paid off."
1. if paid off, maybe the payor only wanted a temporary share price setback. hence, what you suspect is weak reasoning underlying the decision.
2. perhaps the defendants might also sense the weakness in her reasoning upon appeal and seek to settle for now a much higher amount that amarin is more open to paying.
correct me where I am wrong.
Acc presentation this weekend described triglycerides (and other biomarker measurements) did not correlate with reduce-it risk reductions, but epa levels in blood did. higher epa level, better outcome.
MARINE label (triglyceride lowering) should be withdrawn. can that happen somehow?
amarin (for the time being possibly) lost their patent-protected monopoly to sell vascepa without generic competition in the US.
what could amarin do to generics to cause generics to be unprofitable to sell?
mochida epadel is sold over the counter.
no salesforce, just advertising.
does amarin have exclusive agreements with its suppliers? is the vascepa-equivalent API manufacturering market controlled for the time being?
on a per patient basis, how does one determine what indication (be it MARINE or REDUCE-IT), underlies the indication for a vascepa Rx?
mochida epadel ... now what?
halt is a halt. doesn't matter pre, post, or during market.
why would they not have both positive outcome and negative outcome PRs waiting to be released upon decision? why is the stock not halted?
"Anyone with good credit , good income statement , cash for down payment etc will be getting the financing deal of a life time . "
I wonder if it is safe to assume there will be mortgage money to lend as so many of the loan servicers will be forgoing loan payments, either willingly or unwillingly, doing the high unemployment period.
another thing to consider, those who are successful in refinancing their primary residence at 3-3.5% interest rates might not ever move out/up once the interest rates return to levels where the 10 yr treasury is no longer under stress.
the impact on HDO's will be extraordinary
If these persons are given icosapent ethyl for the REDUCE-IT median trial period of 4.9 years, we estimate *preventing* a total 349,817 (71,391/yr) primary and 155,136 (31,660/yr) secondary CVD outcomes; 146,011 (27,798/yr) and 109,508 (22,349/yr), respectively, were initial events.
vascepa, most underpriced drug ever!
CARES Act - Regulatory Provisions in the Phase 3 Stimulus Package – UPDATED
https://www.americanactionforum.org/insight/regulatory-provisions-in-the-phase-3-stimulus-package-updated/
anybody seen anything more specific about this part of the rescue bill?
The shout-out for sunscreen is part of a long-awaited effort to reform the over-the-counter drug industry, added to the rescue bill amid backing from that industry and various health groups. Besides expanding FDA oversight of over-the-counter products, the provision would streamline the process to change safety labels.
@JL
very interesting. in addition, for those taking vascepa who might have succumbed, the length of time they had been taking vascepa, I.e. how long was vascepa lowering their systemic inflammation?
Five more Italian doctors have died from coronavirus, bringing the death doll among medics in the country to 13 as it was revealed 2,629 health workers have been infected.
https://trib.al/Wa0bSR9
can't find any info on mortality rate, but this:
At least 2,629 health care workers—roughly 8.3 percent of all cases in Italy—have contracted COVID-19 from working with inadequate equipment or being exposed to asymptomatic carriers, according to the latest results from the Ministry of Health
https://www.thedailybeast.com/covid-19-is-killing-italys-doctors-the-us-could-be-next
Press conference at 6 pm on March 19th
41035 total cases, currently positive people are 33190, 3405 died and 4440 recovered.
Among the 33190 positives:
14935 are found in home isolation
15757 hospitalized with symptoms
2498 in intensive care
A new study from Italy’s national health authority found more than 99% of people who died from the coronavirus in the country had preexisting health conditions.
Health officials recently looked through the data from the more than 2,500 deaths within the country, according to Bloomberg.
A look at the numbers:
The new study said about 8% of Italy’s population was infected with the virus, which is higher than other countries.
The study looked into 18% of the country’s COVID-19 fatalities and found three victims — so 0.8% of the total — didn’t have any preexisting condition, according to Bloomberg.
About half of the victims had three prior illnesses.
About 25% had one or two conditions.
More than 75% had high blood pressure.
About 35% had diabetes.
About 33% had heart disease.
The study found the average age for those who died was 79.5. according to Bloomberg.
The average age of those infected was 63 years old, the Washington Examiner reports.
The bigger picture with Italy
Italy announced Thursday that it had surpassed China as the country with the largest number of reported deaths from the coronavirus with 3,405, according to The Washington Post.
perhaps you have the cause and effect reversed.