HK...

Where there is uncertainty there is always fear...

"When the thief sees the Holy Man...He sees only a wallet"..

Buddha

MS 83...

Is this Sgt. Francis Xavier or St. Francis of Assisi....

":>)JL

HK....

"Whatever the R-IT patent not a word of it will matter, because the generics will rely on 12 week renewable generic script subsitution at the pharmacy level by pharmacists/level 1 Tier shenanigans to back door steal the indication.... No one on this board has come up with a cogent reason why this will not happen if the generics win...
HK"

Guess you do not read my posts...You should. "Back door my ass.." generics are not even going to be able to get first crack at the Marine label..Unless the generics can figure out a way produce Gen V at a lower cost than Gen Lovaza. (ie Teva's drug)..It's all about the cheapest and right now Gen V and Gen L have identical labels so that 12 week renewable generic script substitution is going mean Gen V is going to be converted to cheaper Gen L..The generics have no pathway to the R-I indication and if they attempt to market the drug as a cardiac drug they will be infringing on Amarin's patents...I am predicting the generics (R & H) both settle..

Next year..The drug plans are going to have the R-I indication (it was only OKed by the FDA in late Dec. after the medicare renewal period)..At that point Amarin needs to change the label name to Vascepa Cardiac..Reflecting that Amarin alone has the right to sell this drug for the R-I indication..Please remember not every judge is going to be judge DU....

":>) JL

Quote: "Use Singer rather than Covington this time."

marjac.. You are missing the point here. The problem was not Sipes and Covington. It was the judge who was not only partial to the generics but was determined to give Vascepa to the generics..

"Everybody knows that the dice were loaded.
Everybody rolls with their fingers crossed.
Everybody knows that the war was over
Everybody knows that the good guys lost."

Leonard Cohen...RIP....

You lawyers need to wake up and smell the coffee..The fix was in and Amarin would be better off spending its money on private investigators..and get in touch with the FBI..(They are not Du fans)..Sorry to upset you SJWs on the board..but most of you have never spent real time in Vietnam..And still think it is a suburb of San Francisco...Forty plus years of of continuous war in Vietnam..has created a deep and abiding sense of frustration with the idea that morality and honesty are worthwhile on their own merits..The payoff is the only worthwhile measure of success and all those rules and laws society puts down are just impediments laid down by the strong to prevent the weak from ever getting out of their slavish existences..

There is an essential theme in Vietnamese literature that has the virtuous young and beautiful Vietnamese girl fall under to influence of the rich and powerful..Taken far away from her family..Over time she is discarded and loses everything..It is the theme of exploitation of virtue by the powerful...

":>) JL

raf..Vs the trial outcome..

I try not to put numbers up when we have no numbers.. Forced to guess I would say Reverse is lower than most posters estimate..an affirmation is higher than most posters estimate and a settlement or more likely settlements are much higher than most posters estimate and the chances of a remand is close to zero....

I do not think this current situation is represents a very good chance to hedge a possible affirmation..I believe an affirmation is already in the current share price..If the AC supports Du we will see a knee jerk drop in the price but Amarin PPS is already way lower than it should be and is not counting the other major markets that Amarin still commands...And the complicated but very real fact the generics will be stuck with the Marine Label and will not be able to successfully shoe horn in the R-I label by off label scripts..Du unfortunately also gored the generics ox when she featured the *infringement by inducement issue in her conversation.

":>) JL

* I imagine the generics will be bringing that issue up at the ACT.

daphne...

Nice post..I plead lazyness in this trial..In the earlier Amarin trials..The NCE and the First Amendment. I read the transcripts, but frankly this one looked like a slam dunk..The Globe trotters vs the Nationals..Covinton vs the losers..So it did not seem to be worthwhile to go over the transcripts..

But you nailed it.."I don't see how it hurts you"...It's no different than Teddy KGB eating the Oreo Cookie. Sipes and Amarin missed it and even Du did not really get it..Since it came from deep in her mind..The unconscious need to assure ...Spontaneous and clear... there for all to see. The defendants were going to win the trial. Judge Du had already made up her mind..

":>) JL

Bouf....

Appreciate your point of view and hope you are 100% correct...

":>) JL

raf....

Its very sad that things like bias have to be considered when we are only asking for honesty and objectivity...

The fact Du made procedural and factual errors in her determination is not open to debate..It is all there in Black and white. If Abe Lincoln was president and running the country we could all be planning our summer homes in Malibu..

But unfortunately times are more like the Harding administration. The truth is MIA..We should never have seen or heard of Judge Du..There can be no doubt as to her lack of impartiality..Every mistake she made serviced the defendants and injured Amarin..A fifth grader could have easily seen she was the most important part of the defendant's law team.

As days go by we see this lying and cheating and downright falsification increasing throughout the media and the political establishment..It is a disgrace to our great country..That we are being increasingly exposed to lying and cheating..And now we can not count on the truth in this appeals trial...because these judges no longer abide by the rules of impartiality and honesty..But vote their party line..Just like their agent..Du did out in Reno..

":>) JL

raf...

Quote: We all believe that Du made mistakes and now those will be examined not just by random inexperienced judges, who may or may not know the law / familiarized with the technicality, but by judges who are used to seeing this highly technical material. The total opposite of Du."

You are ignoring the the three elephants in the room..All would be as your fantasy assumes if all these judges were kind and objective...But sadly we know that is not the case..These judges have their own biases when it comes to patent litigation; the judges will likely vote these biases..

So we must wait.. our bows fully drawn...our arrows knocked..but the target is much too far and all our legal reasoning is just a fools tale..We are at the mercy of the draw...

":>) JL

G...

Quote: "They (Covington) did not hiring an expert to write a summary about:
(i) what is drug
(ii) what is LDL-C
and so on ..."

Agree and perhaps one of the problem for Amarin was..The legal profession was making the mistake that progress and knowledge in the medical field is similar to the way it develops in the law..The law is far more democratic and judgments and precedence are tabulated into all those big books and virtually any of them can be cited. Based on their logic and merits..Rather than the status of those in making the the statements..or even their inventions and discoveries..

Medicine is more of a hierachy..more like the army. The whole Vascepa story is a classical example...Citing Mori..the way a lawyer might bring forth a determination, a trial verdict or a precedence. Dosen't work in medicine...In the vast world of medical science or clinical medicine Mori simply does not exist..What Mori said or did had no effect on the progress of medicine. Mori was just some guy working in Australia and his opus..Was posted in an obscure Journal of Nutrition..The idea that Mori's ideas or trials did or could frame the accepted physiology of EPA is ridiculous..
Academic medicine and Peer reviewed journals are the only sources that anyone in clinical medicine pays any attention to and nothing could be considered "obvious" unless it was declared so in these elite circles...

Look at JELIS...JELIS was a righteous CVOT..Sure it had some drawbacks..not double blinded..Race and sex were limitations..But the results (in retrospect) were very impressive..So what happened ??
The AHA "reviewers Beatrice Rodriguez and HMS reviewer Mozafarian tore the whole study apart line by line and page by page...And when it was over..nobody in Academic medicine paid any attention to JELIS..Nobody thought putting patients on high doses of EPA would obviously result in dramatic reductions of CVD events including strokes and even Death from MIs..

If medicine was like the law..where the merits of precedence are determined by reason and logic..Then we would have Vascepa on the market twelve years ago...In medicine we don't have those big books full of court talk with which to frame our arguments or decisions..That is reality....

":>) JL

ACST...

A long running saga that took a lot individuals in..The "Krill Oil" story..Just because it costs more does not mean it works better..Though there are those who think it does..

A lesson for us all.

":>) JL

The Amarin Ihub board..

The preferred author of MIT students and grads is Verner Vinge..a mathematician who writes futuristic science fiction and one of his central themes is the collective wisdom that is generated by the consensuses of thoughts on the internet. The idea is the internet by collecting the mental power of many intelligent individuals results in a form of super intelligence..

This might not be the norm on the internet..but I do believe this board at least begins to suggest such a possibility..We don't always agree but we have all the arguments to compare and sometimes we do have a high consensuses...The opinions on the way the best way to approach the upcoming Appeals trial is a good example..As ludicrous as the notion might seem...The great lawyers Amarin has hired (Singer) could benefit from reading the board..Not because of the superior intellect of any one poster, but because of many who collectively do create superior intelligence.

I do think this board is an asset to Amarin and if they are not using it then they wasting something very valuable..

We have a high percentage of positive contributors on this board..More than any other board I have ever read on the internet..Of course we have some who are disruptive...But even these contribute as they must be addressed..

Keep up the good work...I do believe this will pay off.

":>) JL

HK...

This is probably the most important determinate of why Du was so wrong..In 2012 when ANCHOR was completed..Virtully everyone in the lipology field held tht trig lowering ALWAYS resulted in the LDL-C levels increasing..Here to fore Trigs had been considered a risk factor for CVD events.

http://epadruginitiative.com/press/fda-puts-patients-at-risk

FDA convened an Adcom which met on Oct 13 1013..The independent panel voted on the now famous Mary Parks question..The question asked was considering the ANCHOR trial results (in light of three other trig lowering trials [Thrive, ACCORD, and AIM-HIGH]..none of which showed convincing evidence that trig lowering lowered CVD event risk) were they the panelist confident Vascepa in the suggested dose lower CVD event. The panel said no..The ANCHOR trial was not designed or powered to answer whether the drug would lower events or save lives inn those with CVD..The FDA continued in a full sweep to declare they no longer considered elevated trigs a risk factor..A position held by the AHA the ADA and the NIH..They followed shortly by reneging on the SPA they had granted Amarin..On the flimsy basis that new scientific evidence indicated EPA's ability to lower CVD event risk was unlikely..Central to FDA's turn about was that trig lowering did indeed raise LDL-C and FDA held that only LDL-C was a legit bio marker for CVD event risk..

Such were the events leading to the R-I CVOT..

It is inappropriate to consider points of view in clinical situations such as the therapeutic benefits of N-3s or "Fish Oil." By Picking out one study which supports ones point of view, where there are literally hundreds of other trials, studies or paper that do not agree. This is the very worst kind of kind of Cherry picking..And is "Fake Science" or "Judge Du Science"..That does not in anyway indicate the overall opinion of the Medical field..The truth is there was no consensuses.At the time of MORI. MORI was not a KOL..The issues were controversial and still were until a short time ago..Nothing that MORI said or did had any effect in the time and place where he said or did it..

The general view (the most agreed on) at that time would have been high Trigs are a risk factor for CVD but lowering trigs raised LDL-C and this was confirmed (expected) by the Friedwald Equation and the clinical specialists who treated Atherosclerosis. And the benefits of trig lowering were not great enough to defray the risks of raising the LDL-C..

":>) JL

Hamoa

excellent summation..Thanks for your professional opinion...

":>) JL

G...

God you are good..I have to admit I have seen few with the range of information you possess or have the facility of digging it up..

With real respect.

":>) JL

zip...

Thanks for posting..I agree this is the lynch pin of where Du went off the rails and into the chasm..Obvious is a subjective term..what is obvious to Albert Einstein..might be unfathomable to the rest of the population..

History including medical history is rife with ideas and notions which were at one time considered obvious and were later debunked..Going back 1500 years..The world was obviously flat and was the center of the universe...It was obvious that no machine which was heavier than air could fly..

And in medicine..there is a statement.."The questions never change..only the answers do"..At one it was obvious that amputation stumps should be treated by immersing them in boiling oil..When I first entered Med School..Phlebotomy (bleeding) was still widely practiced and considered the standard of care..Today it is used only in very few situations..Doctors are cautioned about "experimentation"..and the FDA does not approved drugs without objective measurement. The Honorable Judge Du's opinion of obviousness does not accord with FDA's "Marketing Requirements process..there are no free rides..no assumption...No "That's obvious"..It all about the data...Du has simply used hindsight and the MARINE data to support her baseless contention.

This is not reality..The FDA has seen too many "Obvious" notions go down the drain..like Minot and Murphy getting the Nobel Prize for showing that obviously Folic Acid deficiency caused Pernicious Anemia...Later this was shown to be fallacious and that Pernicious Anemia was really the result of Vit B-12 deficieny..By William Castle..

Castle never got his Nobel...

As a play on the old adage.."What would Jesus do ?" Du's opinion is not consistent with what would FDA would do..We already know what FDA thinks about "Obvious"..Its not in the FDA's lexicon...In the FDA..It's "Show me the Data..Without statistic significance in a peer reviewed and accepted
Trial..A drug has no status..All the legal profession notions about "obviousness" are no more important than how many angels can stand on a head of a pin...Its just mental masturbation..Using Graham..(which is about a plow design)..to argue obviousness in a clinical drug..elevates stupidity to a new high..
The law is an ego maniac..Listening to judges discussing medicine is no different than listening to Doctors discussing the law..Very few doctors could pass the bar exam and very few judges could pass the state medical exams..

":>) JL

TTE...

Quote.." Can someone please delete all this bickering over who crossed which t and dotted which i?

We have serious shit to focus on here now."

It is the who crossed which t and dotted each i...Is the serious shit here...


">) JL

jm..

Quote: "Whats your feel on the brief so far."

I am not a lawyer..and no one should act on anything I say or post on the subject of this Appeals trial..

That said..what I glean is Judge Du did make some procedural errors..eg..shifting the burden of proof of patent invalidity from the generics to Amarin and not giving enough attention to secondary considerations..She also made some factual errors regarding her interpretation of the facts in MORI and Kur..

From what I could understand the generics briefs are now arguing Epadil and I do not know if that subject was brought up in the DC trial or how much new information; not addressed in the DC trial; can be introduced in the appeals trial..My impression was the that new information..not addressed in the Reno trial can not be used in the Appeal..

What is perplexing here is how lame the USPTO must be..Does their opinion
mean nothing???

My layman's impression is the appeal will be decided on whether Du's procedural and factual errors are enough to get her reversed or whether the generics present a strong enough case for obviousness..and that would seem to revolve around how much new information can be introduced.

":>) JL

ToddRobert...

Are you Ned Flanders??

Quote: "The patents were already made invalid....why/how would a settlement by Reddy make sense now."

Easy...The patents are worthless.

":>) JL

About the Apotex settlement..

I for one think this is a big deal..I would not be surprised if both Reddi and Hikma also settle I have predicted earlier that was a very likely to happen..

All these generics get from the Du case if they win is next to nothing. The MARINE indication is not going to unlock the safe that holds the R-I indication by simply off labeling. The drug plans are not dummies and Reddi and Hikman are going to see their MARINE label scripts get way laid by Generic Lovaza..That's what the plans did to Amarin and the generics will be even more harshly treated..

What I am saying even if Du does not get reversed the Generics are not in for a huge payday..

Suggest..Buy Amarin...

":>) JL

Meow...and marjac...

No malpractice here..They were writing for the Marine label..The drug plans have still not acknowledged the RI label which came out in late Dec 2019 and was too late for the Drug plans to include it in the 2020 Tiering. We can thank the FDA for dragging its feet on this...
I am not a lawyer but have forty year experience being a clinical adviser to the Malpractice providers..

":>) JL

KIWI..

Believe me I have...I appreciate your information..I will take it up with my surgeon..

Than you very much..

":>) JL

G.

I guess you are the only infallible human left on the planet..

I feel very fortunate just being in your devine presence..You see being only a poor helpless human..I do not consider the the NCE decision on par with the patent anullments.

":>) JL

raf....

IMO this is your very best post..The chain of events in this case is more bizarre than Alice in Wonderland...With Judge Du playing the "Red Queen". The legal system needs an overhaul..Why do we have these governmental agencies like the USPTO or the FDA who cost the tax payers so much if one brainless ignoramous of Judge can strike them down with no rhyme or reason..Other than it suits her fancy..I hate her and the cowards who go to work at the patent office..and the FDA..

Its double scary that we do not hear a peep out of the USPTO or the FDA..

WTF is going on here...

":>) JL

Kiwi....

Very impressive..and definitely to the point..I will be seeing my surgeon on Friday...and I will bring this paper along..
Thanks for posting this.. This might have investment possibilities..

Thanks..":>) JL

We have a good chance of winning the appeal for all the reasons given by posters who are lawyers or just have good common sense...

I think there is a good chance the generics will settle..Winning the MARINE label reminds me of the time I won first prize.. a Schwinn bicycle...Second prize was a week long trip to Chicago...Someone cracked, "third prize was a two week trip to Chicago"...I think the generics get third prize here if they win the appeal..

":>) JL

Kiwi...

Why would I put you on ignore??

I did have ultrasound Doppler of both carotids and my R leg..The Anterior Tibialis Artery is occluded...in my R leg...I don't know much about
Lithotripters..use in the popliteal area..And I don't know whether the vascular surgeon knows much about it either...

Surgeons can get very pissy about other professionals second guessing them.

I requires all the delicacy of removing a strange breast from an evening gown..

This is not my area of expertise.. Messing around in the popliteal area can be very risky...I remember one case I did in Vietnam ..On a Cambodian who was shot by a minigun. He had six bullet holes on him neatly spacded going chest to toes.He had a GSW of the popliteal trifurcation and would definitely would have had a AK amputation in Cambodia.. I tried to reconnect the vessels..but the anatomy is very complicated. He had problems with his many other wounds..and eventually died of sepsis..One of the ones who made it to the hospital that did not survive.. He was very young and was a victim of the Cambodian system where they sent young soldiers into Vietnam most of them were killed by NVA or VietCong...Who were right up there as the best fighters in the world..

":>) JL

Hitchie...

OMG...You got tested three times before you came up positive..Very scarry..I have not had fevers, or lost taste, no chest pain but have productive sputum and coughing spells. I am going in for artery checks..Both lower extremities and carotids..Not sure how invasive these test are going to be,,I'm hoping its all Doppler..

The facility is like the rest they don't want you to show up if you have a positive C-19 test..

Seems like in Florida we are seeing another surge..But you can't be sure because the tests are so unreliable..C-19 normally produces the URI's that we call colds..and the rule with these epidemics is the vectors usually get weaker and weaker with passing time due to "transference"..they need a host, but as they pass through to the next host they get weaker...It's like these brainless forms of organic molecules have a fairly well thought out strategy..They understand if they kill all the hosts..Then they will all die..

There is so much much we don't know...

":>) JL

James...

Yes I saw Berger win...Talk about the luck of the Irish..His two main competitors both missed straight putts of less than 5 feet on the 17th hole.. Both were "horseshoe" putts where the ball rimmed the cup and came out the the same direction the ball it approached from..

My right leg is pretty crappy but my golf game is very good..Played Sat and was even par on the back nine..Have cashed in the Orlando Skin games six weeks in a row..(that's against an open fields with some mini tour wannabes).

Nice to see Berger win one..His father was a great Tennis player..

":>) JL

hitchie...

Wow..Must have been scarrier than hell...Were you taking Vascepa before you were diagnosed??..Did you continue to take it during the period you were testing positive?...

I tested negative about a month ago..I had a occlusion of my R popliteal artery..Had an atheroplasty..but have very little relief of symptoms and Will be going back for further tests tommorrow..I did test negative for C-19 but still have a number of viral symptoms cough, sputum and wonder if I might still have the virus..Been a month since I tested negative.plenty of time to get infected...

Nice to hear you are doing well..

These have been rough times...but I am predicting a full recovery for Amarin or the Hikma and Reddi will settle...

":>) JL

Pharmadude...

Quote: "If GV becomes available every V script will be filled with GV if it is cheaper than V."...

This is going to depend on the indication..,For the MARINE (High trigs label) Gen Lovaza will continue to be the substitute of choice because it will be cheaper than G Vascepa..(and has the same FDA Indication and usage.).

Here is the part everyone should enjoy...Since Generics have not won the right to the REDUCE-IT label..(they only have the MARINE hi trigs indication). Then only Amarin can sell Vascepa for the REDUCE-IT (CVD lowering indication)..The generics can plan on "off label" sale of V for the REDUCE IT indication..but this will not work..The drug plans will apply the law and restrict Gen V for MARINE trig levels because they could be sued for patent infringement..So they will just convert to Gen L regardless of the generics wishes to prescribe off label...

Amarin alone has the right to the R_I label...and there is no cheaper alternative..And Amarin could (will) sue the drug plans if they converts its scripts)...That law suit will be coming down the road...

Don't sell your Amarin shares..Buy more if you can..better time are coming soon regardless of the results of the Appeal.

":>) JL

G..

Thanks...

":>)JL

Toanoman..

The drug plan or the doctor does not decide the drug plans actions..The drug plan determines the indication they are covering the script for by what is described on the drug label.If the doctor and the patient decide to use the drug off label..They can do that..But it is not going to effect the price or tier the drug plan determines..You may appeal the drug plan's decision, but that does not mean they will lower the price..I know..MY PCP appealed to Silver Scripts about my co pay (Tier 4) and explained I had several CVD issues..and Lovaza had no recognized CVD benefits..The company denied the appeal. On the basis Gen L had the same indications..And was a cheaper alternative

":>) JL

KIWI..

Teva's settlement allows them to enter the market in 2029..or perhaps earlier under certain circumstances. Doubt those mean they will enter this year..

From Amarin...
In the lawsuit, Amarin alleges that the generic forms of Vascepa adverse parties seek to market in the United States infringe upon multiple issued patents owned by Amarin. As part of the settlement agreement, Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029, or earlier under certain customary circumstances. The agreement is subject to a required review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

G. Any idea what certain customary circumstance might be?

":>) JL

Ilove...

PCPs and other clinicians are up to their eyebrows in paperwork and computers..A clinician might be willing to write a letter to a drug plan to try to get a lower script cost for a patient..There was a time when drug plans might honor the request..But more than ever drug plans are pushing back..Insurance companies can usually out muscle any opposition..or out stall them or just ignore them..Insurance companies have personnel whose job is just to do that..

As I noted earlier insurance companies can be very dumb when it comes to their actions..but their actions usually end up bolstering their bottom line..

I think the fact Teva took a settlement (and a relatively cheap one) says a lot about how much the Marine indication is worth..They have to know the Lovaza vs Vascepa story better than most...Teva is one of the sharper knives in the drawer...I would not shed too many tears about Amarin losing on the Marine label...The real money is the R-I indication and currently there is no alternative for that..

The sell off is way over done..Be patient the PPS will be coming back..

IMO Amarin has not lost very much..

":>) JL

G...

Quote.." Do you consider that a lot of plan tiering as:
1: preferred generics
2: non-preferred generics
3: preferred brand
2: non-preferred brand

Most is generic vs brand...if it is for the same indication..The important part is the indication is not what the doctor wants. It's what the drug plans determines from the FDA label...Although "off label prescribing" is perfectly legal..the drug plans usually stick to the label indication..They are not playing doctor..


Quote: "several companies produce gen Lovaza ... inc. TEVA"

ans. No doubt..

Quote: TEVA will produce gen Vascepa also.It will be Teva against Reddi and Hikma and Teva..

ans..no doubt...

How about the pricing of gen Lovaza by TEVA against gen Vascepa by TEVA ?

Interesting conjecture ...What do you think??? Teva did settle..I would not be surprised if they stick to GL...

":>) JL

zmanindc...

Its an open board dufus..

You want to throw a temper tantrum..The you should go into the nursery and shut the door..

":>) JL

ilove..

Quote..I

zip...

Quote.. ..9 conservative senators against her nomination and 10 liberal senators for her..

Amazing...Too bad we can't get a vote for her on this board as to a "firing squad."
OOPs..Now I will have all the board's SJWs breathing down my neck

..Honest guys I am not a hater..and did not kidnap the Lindbergh baby.

":>) JL

zmanindc...

quote.."Its like we are all the way back prior to reduce-it, unbelievable!"

Not only unbelievable..Its not true...Time to sell any shares you may have and move on...

":>) JL