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I believe I read that this started in 2012 !! YOu are correct we are mired in a quagmire of legal mud, void of scientific clarity and clouded by political leanings .... I hopped in at $4.xx will probably hop out soon as I dont see any relief for AMRN and my capital can be used better elsewhere
AS an FP I have been prescribing it for over eight years - tried to educate all my local cardiologists about it before REDUCE IT - none currently use it - would be interesting to see who writes for more statins etc FP's or cardiologists. I manage almost all of my patients lipids HTN and diabetes as do most local FP's since there are many more FP's than cardiologists in my area more lipid management is done by FP's . MAny patients who need vascepa wont even come under cardiology radar - ie DM2 with two risk factors etc no cardiologist in my are provide diabetic management. IN addition , they most often return the patient to FP care even when they have preexisitng CAD - none of these that I receive are on Vascepa - unfortunately I have not had one cardiologists initiate vascepa
Wow what a can of worms ..... but looks favorable for AMRN ... until clarification occurs, which may be years, wise generic producers would avoid this ... AMRN should be prepping to determine how to track RXs for REDUCE IT indication and then seeking reparations --- I have numerous ones already -
"As Chief Judge Prost pointed out in her dissent, Teva followed the law to a T but is nonetheless on the hook for $235 million. And generic companies have been doing this for years; are they now all liable for induced infringement? For industry, the uncertainty leaves a wide open question of whether taking advantage of the skinny label process is advisable."
hmmmm .... diabetics lives dont matter ?
When the court cant even get the gender of the judge correct its highly unlikely they will have naythign else correct .....
Of course this begs the question as I previously posted ...has Thero spoken with GSK ? Has he reached out to their CEO for guidance ? Has AMRN put together the pharmaceutical coalition to gather resources to combat Generic infringement ? Much like the NRA has a giant slush fund to protect gun owners from legal battles - BP should be doing the same, gathering knowledge and expertise while using their immense resources to apply pressure via their lobbying - AMRN should be using this case as the warning shot and then leveraging BP concern for mutual benefit - this case should be used to set off a huge cascade of concern and releasing the flood gates of BP to protect THEIR business - THero should be calling every CEO and advising them of what has happened explaining the risks that this represent to their business and forming this coalition ......
Not true
2019
ADA updates Standards of Care to reflect REDUCE-IT, DECLARE-TIMI 58 findings
The revised standards now recommend that icosapent ethyl (Vascepa, Amarin) be considered to reduce CV risk for patients with diabetes who have atherosclerotic CVD or other CV risk factors and who are prescribed a statin and have controlled LDL cholesterol but persistently elevated triglycerides
If ...If...AMRN had a clue on how to market and prep insurance companies ...
All day long I get notices from insurance companies --- Patient x is a Type 2 DM and not on a statin please evaluate ..... not once have I received a letter stating
patient x is a Type 2 dm with two risk factors and should be on vascepa please evaluate ....
WHY ?
GSK took on TEVA as their deep pockets were able to grease some wheels - AMRN has no deep pocket no grease
I guess what I find rather ironic here is that the judges dont even know they were lied to - I guess they dont even care that they have been played for the fool
It certainly can .... power tends to corrupt and absolute power corrupts absolutely .....
I have no understanding of the legal system but what I see going on here is "How dare you peasants even insinuate that you have the right to question us!"
Well this is not at all surprising if someone can delete 30,000 emails and not have anything happen then apparently lying to the court is just fine if you are the right person or company ....
The real risk to EPA is actually the SGLT2 class which has shown substantial reduction of CAD risk and progression of CDK - very interestingly by reducing fibrosis and inflammation. Of course one then has to ask about the potential combo EPA / SGLt2 and then why not EPA / SGLT2 / Statin and ACE in one pill ....
en banc but request INDEPENDENT consultants to explain the science - judges need access to statisticians and people of science who are independent to allow them to come to the correct scientific truth - you could have 100 judges but if they dont understand the science then of what use is it ? anyone who thinks they are capable of understanding all fields and disciplines and all of the finer point within in those realms is either God or a liar - I find the latter to be more likely - there is a reason that science degrees take many years to acquire - you cant gain that knowledge and understanding in a few weeks
en banc but request INDEPENDENT consultants to explain the science - judges need access to statisticians and people of science who are independent to allow them to come to the correct scientific truth - you could have 100 judges but if they done understand the science then of what use is it ? anyone who thinks they are capable of understanding all fields and disciplines and all of the finer point within in those realms is either God or a liar - I find the latter to be more likely - there is a reason that science degrees take many years to acquire - you cant gain that knowledge an understanding in a few weeks
If the judges cannot understand the science how can they make a decision based on truth ? What I see as the real problem here is a legal system whose egos's refuse to accept the fact that they are untrained or incapable of understanding certain issues. Instead of viewing that as an insult to their intelligence they should do as any POS does - ask for a consultant to explain it to them .... to allow judges with no degrees in science to try these case is a complete and utter fiasco which makes the legal system look like a bunch of clowns allowing ego to obfuscate truth .
The 800 reps should be meeting with insurance companies on a daily basis explaining REDUCE IT results
... and if HIKMA is guilty of submitting incomplete data can AMRN sue for damages thus far ?
I hope you are correct - AMRN should have reps reviewing every formulary
io_io just so that I understand - you believe that the US justice system is based on the personal feelings of the judges - has nothing to do with science, evidence, established law, facts .... it just all depends on if someone is mean to them and their decisions are based on that first above all other evidence ? YES or NO ...
Rx's are not going up because insurance companies are tightening the screws substituting omega 3 now all the time - and as one gets away with it others follow - the number of rejections on Vascepa continues to rise
...because on Ihub he had to maintain the persona of a hungarian whatever ... its a persona a cover do you really think someone would be that well informed and not be a key player ?
WOnder if there is any consideration to a branded statin / sglt2 / vascepa combo
If you can delete 30,000 emails and destroy cell phones and not have anything happen to you --- perhaps io_io is right --- US justice is just dependent on the whims of a judge and facts evidence and due process are but a sham
So what you are saying is that law in the USA is based on the personal feelings of the judges - has nothing to do with science, evidence, established law, facts .... it just all depends on if someone is mean to them, then they can make up any law they want ....ok
but their materials as to proposed market value revealed intent to market under REDUCE IT indication
WE need A tweet indicating to Trump that his life was saved by a small biotech company - does he want innovation and life or stagnation and death ? SAVE AMRN MR TRUMP ONLY YOU CAN HELP ...
HIKMA also already revealed intend to capture cardiovascular market with previous labeling of potential market
EXCELLENT UNBIASED REVIEW THAT DOES NOT LOOK THAT FAVORABLE FOR AMRN
Yes its bizarre that one arm of the government said its not obvious you must run a trial and then another branch of the gov allows infringement with no consequences - then for what possible reason would any firm perform any study ? THis is why a coalition of pharma should be hopping on this matter and that coalition should be organized by AMRN
OF course presenting to these judges the reality that limitation of innovation will ultimately harm more peoples health care is the opposing argument - we can have the health care of cuba - that even lacked basic bandages or we can have monoclonal antibodies being used against covid -
AMRN presents at the European Atherosclerosis Society https://www.firstwordpharma.com/node/1762627?tsid=3
You cannot judge what you dont understand .... judges trying scientific matters either need to rely on non biased consultants or themselves be trained in the art .... this is so exceedingly bizarre that it is difficult to comprehend - even in the humblest of avenues judges are trained in what they judge - this is like having a plumber judge the Olympic gymnastics ... a person who is honest with themselves would say - I dont understand the subject I will need to have individuals knowledgeable in this arena explain to me or defer to someone with this knowledge - if an individual cannot be honest with their own intellectual capabilities do you expect them to be honest in judging others ? but then again when has honesty ever been utilized in the legal system ....
Brilliant !
I write VASCEPA DAW and 80% of the time it gets rejected I took one of these on - filled out two prior auths both rejected - time about 2o minutes each . Went to external appeal that was about two hours of my time including providing scientific articles writing up this patents case etc . I write approximately 90 Rxs per day - do you think any doc is going to spend two hours to fight this - it costs me $450 per hour to run my office - taking this on costs me $900 or perhaps like the many wonderful patients who hand me their ten page disability 15 page family leave the list goes on and on and on forms and say oh you dont have to fill that out now - oh really so I can fill it our this evening when I have nothing else to do ! OH boy !!!
I use to think that and would try to give them the benefit of the doubt - however several years back I felt that they were in way over their heads - Management has mainly been interested in their own well being and pockets and now grasping at straws. There are two reasons why people are quiet - the first is they know exactly whats going on and dont need to ask any questions - the second is that they are totally clueless and dont know what questions to ask . AMRN sits in the second group. I bought at $4.xx not because of AMRN management - but in spite of it. I believe intrinsic value of stock is at least double. If I can double my money in two years that works fine for me
Pretty much ... but you would have to know what judges are appointed to the case ... unfortunately it is eminently clear - even in the supreme court that people are people and are often blinded by their own value system - it takes an immense logical person to step outside of their own logical framework ... for example let me give you an example to get everyone riled up - look at abortion - I oppose it not based on religious beliefs but rather on scientific logic . If you tell me that its "a person " at 16 weeks but not a person at 15 weeks 6 days 23 hour 59 minute 59 second and 10 billion vibrations of the cesium atom ( atomic time) but then one vibration of the cesium atom later - poof !! it magically turns into a person - well frankly I find that unscientific and I am hard pressed to find a logical way out of that argument - yet we know that the supreme court would divide on political leanings