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circ...
I like most of your posts..but do not agree here...I look at the Amarin situation like the COV1D-19 pandemic...Very scary with some definite risk..But we pull out of it (most of us) and life gets back to normal..
JMO..:>) JL
flubber...
Quote: "The only problem with Vascepa, due to the patent ruling, is that icosapant-ethyl can now be manufactured and sold by any Joe-blow generic company in the world."
Not at all the case..can no sell drug without an FDA ANDA...and there won't be one coming for at least two and one half years...
We need to be more patient and understand the drug is so valuable that others want to steal it but this judges decision is just the first punch thrown and not the end of the fight...Not anywhere even close..And we are not defenseless...
":>) JL
jasbg...
Very good post..No good panicing.. Selling the company at these prices is not a good idea..Amarin has not been killed,,Amarin is Vascepa..Vascepa is very much alive and very valuable...potentially the most valuable drug in the world...Do not panic and give it away.
I like your idea and agree we need to get the story out and about...
:>) JL
PS...Biotech Billionaire's name is Jason...
invest...
They "the PTO" will read her (Du"s) pathetic interpretation and know she is an unqualified moron...How bout everyone get off your sorry asses and write letters to the PTO and to the head of the appellate court in District 9 and explain what a moron this Federal judge is...She has 4 appellate reversals in 44 cases (got to be close to arecord..They know she is a stupid...Write them and let them and let them know you know she is a stupid...Stick to the facts..
She belongs on the bench alright...in the park.
:>) JL
golf stud...
Quote: "JL what do you see as a way to get out of this mess by amarin as it looks like an appeal will take along time and may not be a win?"
Well first of all I am not a lawyer...but I do know something about the pathophysiology of EPA...And I know the Judges opinion was not based on fact...and her citation was pure BS...What I am saying is the judge was wrong and her verdict was not supported by fact..I give her leaway and assume she is just ignorant and has a big ego...She aint no physiologist.
I have seen this behavior with other judges...On the Medical Malpractice Tribunal in Mass. I was the doctor and we had a judge number 2 and a lawyer makes 3...But the judge decided he was the doctor lawyer, and absolute ruler of the tribunal...and he really did not know squat about the medical issues. But he was making the decision as to which cases would go to court..I quit the Tribunal..They only paid $50 per session.
I think what is important here is to do everything legally possible to discredit and disqualify the judge...and that includes writing letters to her congressman...Judges on the appeals board. And have your experts write the letters...If she does this now she will be doing this to others..I would also reach out to other CEOs in the biotech business and ask them to review her notes and write the appellate court members..You need to stick to facts where she made mistakes. A judge like this is a blight on the land and a potential danger to any company..It is in the best interest of every biotech and drug researching company to remove this "adder" from the landscape....It would not hurt if some members on this board who have some knowledge of drugs and their actions to write letters criticizing her actions...
Remember..just the facts...Not peer reviewed in a recognized Medical Journal. and inappropriate citations and examples that do not address the pertinent medical issue..If only one letter is sent..Then it is deemed personal...If they get a raft of letters then they realise she is a problem..
":>) JL
Jas...
Ok...You have a lot people agreeing with you.. My son wants JT and Kennedy burned at the stake...
":>) JL
Amarin is all about Vascepa..
Mangagement, the courts. the patent office or the courts..Its still all about Vascepa and as long as we have the franchise the the science won't change..If I read the earlier posts they say we sold about a billion dollars worth of V these last twelve months and every month it seems we go up...
I purchased shares at between 80 cents and a dollar when we did not have the REDUCE-IT results and I am now purchasing them at 4.00 Dollars and we do have the REDUCE-IT results...Vascepa...There is no drug like it no drug with such versatility...We can not stop bumps along the road. I don't use margin and I love cheap shares..Vascepa was not changed by the ignorant judge...Her conclusion was twisted...Who could imagine such stupidity from a federal judge..But as stupid as she is..She did not change V..she might have changed the perception but not the drug...25% MACE reduction in stroke and heart disease..The greatest drug ever..and it benefits so many other conditions..
Cant believe I am buying it at around 4$....
":>) JL
nefarious,,,
Ydah..you are not short..Yeah I believe you...yeah yeah.
":>) JL
jasbg.....
Funny how I remember it is a little different than you do...Virtually everyone who claimed fluidity with the law felt Amarin had a very strong case and would likely prevail. I don't follow you..but were you screaming stop" a couple of days ago before the verdict was announced..
Hindsight is always great. These guys decided on their course of action by listening to their legal council...Among those were members of Covinton the number one litigating legal firm in the USA...But they should have listened to you..
This was bullshit decision by a judge who was either crooked as hell or stupider than a fart...She should be not be making decisions. this was not lousy judgement on the part of Amarin...the Trial was a farce.
:>) JL
nefarious..
eh...Shorty the run down is over...Its time for all good shorts to close their positions.. Maybe you did not get the memo...
":>) JL
marjac..
I can't say what things are like in Vietnam in the passage of time and when the North took over...But in my day Vietnam was a very cynical place where morality was not taken seriously...
The example would be if a women left her purse in a bathroom stall and someone took it..Americans would think that was pretty lousy...But in Vietnam they would say what do expect. If you forget your purse and leave it in a stall of course someone is going to take it..
Credit was not a concept in Vietnam..Vietnam Piasters (known as P) were devalued at such a rate that no one ever allowed credit..and there was also the trust factor no one believed someone would pay them later..American greenbacks were not used in Vietnam. MPC (military payment certificates) were issued to the troops..it was the army's printed money...Some Vietnamese in Saigon speculated on MPC For example taxi drivers who held MPC which did not change in value while Piasters did.. But at unpredictable intervals the army would recall all MPC and issue a new design...At that point any MPC that was not turned in for exchange would become worthless. Sometime Vietnamese currency traders would get caught in these exchanges and lose thousands of dollars..
":>) JL
marjac....
Amarin's lawyers should have jumped on the fact that "Mori" was not only not published in "peer reviewed" medical journal It was not published in a medical journal...But rather it was published in a Nutritional Journal. And this would not be considered acceptable by any medical society..Also the study was very slipshod...With 59 male slightly obese males with mildly elevated trigs...The ranges were not given..we know 56 individuals finished the trial, but we know nothing about their ages..whether some were diabetic...whether they had other comorbidities..
In short "Mori" lacked the structure to be considered a valid clinical trial because it lacked information on who were being treated. The FDA would not consider this a valid clinical trial...So Du who is not a physician nor is there any evidence that she has any medical background decides she knows more about this very complicated issue than the experts and feels free to throw out millions of dollars of research and the FDA process and throw them out the window because she determines the results were obvious...The FDA did not think EPA's effects were obvious...they dam sure made the company finish the trial..
This country which my father and my mother died in the service of the army and I went to Vietnam for is going to hell because we have these liberals and leftists...And a bunch of phonies crying social injustice and slinging names around...Well this is the payoff.. Our free loading leaders don't give a dam about how hard we work and how much money we spend on improving medicine...And let these thieving maggots steal away all our hard earned accomplishments..
Nobody has mentioned Trump..He should hear about this...
":>) JL
raise the price...
Worse thing you can do...Plays right into the generic's hands...
":>) JL
Someone on this board mentioned the judge thought Amarin was just selling fish oil...If that is really the case she could be charged with bias...
";.) JL
I've read Mori..
Mori was not a Japanese study...but was published in a Nutrition Journal.
It involved 59 patients 56 finished the trial..there were three groups of slightly overweight males.. Trial was double blinded
A) Olive Oil
B) EPA 1.8 gms/day
C) DHA..1.8 gms...
https://academic.oup.com/ajcn/article/71/5/1085/4729166
marjac....
59 subjects could be significant although that would be unusual...I need the exact study and can not give an opinion unless I can see the study..
I think the good Judge is going for reversal 5 on this one...But please can anyone turn up the real Mori trial ..
tia JL
Re: Mori....
Can anyone give me the "Mori" study this judge is bringing up to make her point on obviousness....Please give me the source...
":>) JL
marjac....
According to loose sources Mori was a small Japanese study.. run in 2010..
The only study I saw authored by Mori was a study using EPA to treat IGA nephrophy (kidney disease)...It used only 18 patients and did not in any way deal with blood lipids..Closing remark was The effect of EPA in patients with IgA nephropathy is not pronounced, but these results suggest that EPA is a safe and worthwhile supplement to the drugs used to treat this disease.
I do not know if this is the Mori study and maybe someone on the board knows..I can say JELIS which was 18,000 patient study done in Japan was reviewed by the AHA (American Heart Association) who panned the study for its poor design...And though this suggested EPA could lower CVD event risk..But was largely ignored by the experts in the USA...
The fact I am unaware of the any other Mori means clinicians did not consider it opinion worthy. And I would say that was the case for any Japanese study in 2010...
":>) JL
Marjac...
I honestly have never heard of Mori before this was brought up at trial...If you can find information on this trial please post it..I know it was not brought up at the PTO..
TIA...:>) JL
Insync2000.....
Very nice post..I will be buying tomorrow... I was lucky to not have my whole wad tied up ( I just had most of my wad tied up)...
I think you want to pay attention to our scripts the next couple of months..Miranda (The judge) has had at least one of her recent judgements overturned..on Appeal...This one I think will make number two...
I have never considered Vascepa to be an ideal drug for generics..Generics are all about undercutting the Brand cost..That works well when the price is jacked up by a company looking to recoop its FDA losses...And goes for big profits...Vascepa is a "volume" drug and should (as I have stated for the past four years" cut their price margins down as low as possible..
The idea that generics are always preferred over brand drugs is not true..Most states mandate the lowest price drug is preferred...Since Amarin has tied up many of the suppliers it may be Amarin can undercut the generics...Most patients would want to use a drug manufactured in the USA or even Ireland to one made in India..
":>) JL
anfla...
The idea that the 889 patent (V lowers Trigs but does not increase LDL) was obvious)...
That is preposterous..The PTO considered this issue and determined it was not obvious. The fact EPA could lower trigs and not raise LDL seemingly violated the Fiedewald Equation..Which was and is still held to be valid. Any violation or seeming violation of Friedewald could never be considered obvious.
History (which the judge does not know)...Involving Lovaza a mix of EPA and DHA...effectively lowered Trigs but received a CRL from FDA because it raised LDL..And so did every other drug which lowered trigs..So how could EPA's actions of lowering trigs and not raising LDL be considered "obvious.
If EPA's actions were obvious then why was Amarin required to run a Cardiovascular Outcomes Trial...Costing millions of dollars and running for over eight years..Guess the FDA did not think the result was obvious or maybe the judge feels everyone the FDA is stupid .
This judge was not present at the 2018 AHA annual scientific meeting where the audience of Cardiologists were polled before the REDUCE-IT results were presented and less than 10% of these experts thought Vascepa would be useful in treating their cardiac patients and after the results were present 94% of the doctors said they would treat their patients with Vascepa...Obvious...absolutely not...This judge opinion is way off.
This judge must have some ego to think she knows more about this drug than the patent office or the FDA..and a room full of cardiologists..
":>) JL
Evaporate was always irrelevant....
":>) JL
@twi....
Why was this stock not halted....????
Now there is a great question....Thero busy counting his money...
":>) JL
correction.
The sentence "This is absolute proof that trig lowering by Vascepa (EPA) was obvious and not predicted by the Friedewald equation."
Should read."This is absolute proof that trig lowering by Vascepa and not raising LDL was not obvious and the opposite..was true that lowering trigs should increase LDL.
My computer is not working correctly and it is difficult to post anything.
":>) JL
Why the PTO changed its mind about the 889 patent (regarding trig lowering by EPA not causing increase in LDL)..From my interactions with the PTO.
For EPA (vascepa) to lower trigs and not increase LDL not to be obvious. Very simply this should not be obvious (predicted) from the Friedewald Equation.
The Friewald equation states.
LDL (low density lipoprotein)= TC (total cholesterol) - HDL (high density lipoprotein) -Trigs/5
This equation is the gold standard for measuring blood lipids and their
relationships. Even though this equation is not accurate for very high trigs..It can be corrected for very high trigs simply by changing the denominator in the trig fraction.
Looking at this equation which has been verified by a study involving over 30 thousand measurements. What the equation says if you lower the trigs and do not change the total cholesterol (TC) or high density lipoprotein (HDL)..Then lowering trigs must increase LDL. Otherwise the Friedwald equation would be incorrect and we know that is not the case.
This is absolute prof that trig lowering by Vascepa (EPA) was obvious and not predicted by the Friedewald equation. I do not believe very many understand that or how it comes about is understood even today. Most likely epa has an recognised statin like effect and actually lowers total cholesterol.
":>) JL
gg.
Quote: "Any Comments."
Yeah..Patent Office (PTO). does not agree.
Ignore is way overdue for you.
Happy Trails,
":>) JL
jf.
OMG..Sorry to hear that very scary story. Cervical spine injuries are the worst and can result in paraplegia or death. You are indeed very lucky.
Sounds like you got first rate care which is not available in a lot of locales. Being on Vascepa may have saved your life as chord compression from swelling in the restricted upper spinal and brainstem near the Foramen
Magnum shuts down the respiratory drive and other vital centers. Vascepa would have decreased the swelling.
Best of luck.
":>) JL
This information was posted by me on several earlier posts..
For example my earlier post 257431.
Unfortunately this is not true of an enclosed ward full of very sick patients with high viral levels in that case the virus can be inhaled because of the high number of people who are coughing a sneezing. This includes contacting the conjuntciva..
":>) JL
ilovetech..
I am not talking about out in the community. I am talking about being in the same enclosed space with patients that are gravely ill,.Big difference
Look at the protection that workers in the Communicable Disease Center use in Atlanta. Maybe you could ask your famous brother how he would felt working in that setting. Maybe he will volunteer.
":>) JL
Value.
Quote.."ggwpq. Incredible detail! Thank you for all you and fellow healthcare workers do on the front line for us and our loved ones. Where are doctors in your similar circumstance sharing such stories on line?"
gg is quoting a message from the Biotech Values..Message board.
":>) JL
Wow..
Amazing clinical detail..
Message...You need to take every precaution possible to make sure you don't end up having to go to the hospital with this disease..I would include not getting near anyone you don't know or do know if you can help it. Wash your hands (and your face) with real soap like Ivory. Wear a mask or something made of cloth that covers your mouth and nose. If you going out Come home throw it in the washing machine and wash it for the next trip out.
You are not going to be able to guarantee the hospital is going to be able to save you if you get the disease..,You can do more to prevent getting it than medicine can do in saving your life if you do get it.
Fortunately not all cases of COVID=!9 are serious, but why take a chance if you can avoid it.
I can not begin to express my admiration for the clinicians MDs nurses and hospital workers who are risking their lives taking care of these patients..And yes I think they should be dressed like Astronauts.
They should be breathing their own air and in space suits. I do not understand why they are not.
":>) JL
bt.
During the Great Influenza Pandemic of 1918. Everyone who left their home In the USA had to wear a face mask or they would be arrested. Even so the Virus killed from fifty to a hundred million people world wide. Influenza, not Corona Virus is the most lethal vector. And though masks do prevent some of the spread of the virus. Social distancing (including quarantines) and hand washing is the most effective way to decrease the spread of a contact virus like Covid-19
I suggest everyone on the board read "The Great Influenza" by John Barry
This book is available on Amazon it is scholarly and can allow us to discuss this current plague with a degree of fact rather than just a bunch of wild statements
":>) JL
golden flyer .
Not airborne..It would be much worse.
":>) JL
gg.
Thanks for the input..Where did I bring up the economy? My message (I guess I must have confused you) was that wearing a mask is not as effective as social distancing...and hand washing.
I guess my message is confusing..Let me try to explain. We know the COVID-19 virus is not an airborne plague..The disease is spread by droplets of saliva or nasal secretions which land on surfaces or other people after coughs and sneezes. The virus then must reach a liquid surface such as the mouth, nasal passages or conjunctiva of another person..The most likely and
probably the most common way the virus is transmitted is hand contacts surface including that of another person. And then the hand comes into contact with the mouth. It might seem that wearing a mask would prevent you from getting near your mouth but most experts say that is not the case..The best defence is to wash your hands with soap or alcohol frequently because it is more difficult to keep your hand from reaching your mouth than it is to wash your hands frequently. Mask or no mask.
I am not oblivious to the state of the economy..and agree it is very important to keep it running..But I am not getting on an airliner in thje near future.
":>) JL
Anyone on this board who wants to educate himself and become better able to understand the risks, the vectors the treatment and the plausable course of this latest "pandemic"..I can strongly recommend "The Great Imfluenza"
by John M.Barry..
Everything you ever wanted to know these creatures Viruses which linger in the grey zone between the living and the non living. They don't eat.don't secrete.Do not have sex..just live to increase their numbers and are sophisticated enough commander the DNA or RNA and use it not only to increase their numbers but to subvert the all defense measures in systems like the immune and inflamatory systems, systems that make the pentagon look like a game of Red Rover.
Viruses are shape shifters and can change their sizes and shapes and do it al the time. The immune system is set up identify self vs non self. They do this using a sophisticated form of Facial recognition. Only they use what are called antigens. Which are molecular interfaces..The immune system uses its soldiers..T=Cells white cells lymphocytes and dendrite cells which either cut the invaders into morsal size pieces whole bodies. The immune system also recruits the inflamatory system.,The brainless., Concoct strategies which include "Antigen Shift" where the virus changes the face of its molecular structure causing the immune system to no longer recognise them as invaders.,This is what happens in Pandemics.
Historically the most serious viral pandemics have been influenza viruses and not corona viruses.
So far this current does not look as violent as the 1918 pandemic.Epidemics are far more common than most of us realize. That could all change.But the fact this is not an influenza virus contagion makes it less likely to become a super pandemic. This latest one is being confounded by a huge Political issues which are commandering the vurus issue.
":>) JL
Masks are not useless. But they are not as effective at preventing the spread of the virus as maintaining a distance of six feet or more from others. And washing your hand and keeping them away from from your mouth nose and eyes.
The virus is not spread airborne it is spread infected individuals' droplets or fluid that contaminate surfaces or individuals. these individuals introduce the vector into the mouth or other mucus membranes usually with their hands. That is why washing your hands and keeping them away from your face is so important, Face guards are so important for hospital personal because they come into contact with patients who are infected. Contact, over very short distances; distances where it is likely to be infected by coughs or sneezes that directly enter the mouth, nose or conjunctiva.
":>) JL
BTT.
Quote. "If everyone wore masks and maintained social distancing (without lockdown) from January of this year, do you think we will have 80,000 cases, 1200 deaths and 2000+ critical patients today? How would the virus have spread in this imaginary scenario?"
Two points regarding your question. The first is the enormity of numbers and the definition of severity..1200 deaths..The estimates of the Great Influenza of 1918 and onwards was up to 100 million deaths world wide and the world population was about one third of what it is today.. Some educated would call this contagion..a drop in the bucket. Add in the fact the 1918 epidemic targeted the young and healthy. And it is said they died twice. The second issue is the masks. This contagion is not airborne. This agent requires contact and that means social distancing and hand washing is very much more important than wearing a protective mask. Unless you are working in a confined space with known Covid-19 patients. Or living with them. The important thing has very little to do with wearing a mask..The important thing is wash your hands. Don't put them in mouth, don't rub your eyes or pick your nose.
I don't know about the rest of your comments. Pretty clear you are not a medical professional. Seems the disease favors those with OCD more than any other group.
":>) JL
KIWI.
These numbers are not impressive MGH has thousands of workers.Same for the Brigham.
At any one time these numbers would be within rounding error. The only thing tht makes them sound scary is they are C-19s wonder how many worker are out with the flu?
.
My computer keyboard is on the Fritz. sorry for the anti German comment Hamoa..I really don't hate Germans..(except Hitler)..
":.) JL
Bouf.
Since when is Bill Gates an expert on health care strategy. Bill Gates lives in house surrounded by water. (I was told by one of my patients whose husband was good friends
":>) JL
KIWI..
Please..There are more than ten teaching hospitals in Boston and the area. There about 251 thousand hospital workers.in the Boston area..
I don't think 100 of them out sick is going to bring things to a roaring hault.
http://commcorp.org/wp-content/uploads/2017/07/Resources_Health-Care-Workforce_Employment-Structure-and-Trends-in-Massachusetts.pdf
":>) JL