The role of genius is not to complicate the simple, but to simplify the complicated.
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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.
not entirely certain it works, but word is spreading and countries are reacting
https://www.pharmaceutical-technology.com/comment/parallel-export-covid-19/
Cell Research, scientists at the Wuhan Institute of Virology’s State Key Laboratory of Virology write that
https://www.nature.com/articles/s41422-020-0282-0
"COVID-19 pales in comparison to influenza"
does it matter? it's not one or the other ... it's one PLUS the other ... even more unnecessary deaths
italy - 463 deaths / 9,172 infections = 5% mortality
what gives? under reported infections?
will ACC presentation embargo be lifted?
U.S. hospitals currently have about 45,000 intensive care unit beds, according to a report from Eric Toner and Richard Waldhorn at the Johns Hopkins University Center for Health Security.
In a moderate outbreak, about 200,000 Americans would need ICU beds, the report says. And in a severe outbreak, the researchers say, that number would soar to 2.9 million.
The availability of ventilators, which are machines that assist with breathing, are the most obvious example. The U.S. currently has about 160,000 ventilators available, taking into account both what hospitals have on hand and what the government keeps in an emergency stockpile
https://m.huffpost.com/us/entry/us_5e6521f9c5b6670e72f9b902?pz
i know we are not committed to the belief that the royalty is 20% of net sales ...
interesting metric ... what is the count in US?
All over the country, **intensive care** departments are hosting 567 infected patients, while the national capacity is 5,395 beds.
https://www.aljazeera.com/news/2020/03/coronavirus-wreaks-havoc-italy-tests-limits-health-system-200307112350888.html
hopefully, in the same manner in which the public is expected to react now. avoidance and improved hygiene.