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COVID-19...
What you should know....
Although the world wide Influenza pandemic was caused by a different viral strain..One that was far more lethal and spread airborn which is much more effective than COVID-19 which is transmitted by droplet on surfaces and then hand to mouth: there are enough similarities to teach us what should work and what we should be doing to stop the spread and treat the disease..
The 1918 pandemic is thought by most experts to have started in Haskel Kansas.. The first cases in this relatively remote area of Kansas. (Near where Dodge City had been.) were relatively serious and sudden cases of the Flu..The first doctor who treated them wondered whether this was a new form of influenza or what was call La Grippe..The symptoms however were different than routine Influenza..In that cyanosis (a bluish color around the mouth and extremities caused by lack of oxygen in the blood..And patients reported serious bouts of pain..excrutiating pain in various parts of the body..and bleeding from the nose, mouth, eyes, ears..and vagina was common..Patients developed fevers in the 103 range..and died. The first victims were in the 20-35 year old range.
The disease did not fit into any particular category and there were many guesses on the diagnosis..Some thought it was Dengue (called Break Bone fever because of the pain..Others speculated it might be malaria because of the temperatures..Pain above the diaphram suggested it might be Cholera...
The disease developing in a remote area might have little troubled the world and might have just died off from lack of hosts...But near that area were several army bases the thanks to Pres Wilson we were gearing up for our entry into WW1...And as luck would have it one of the young soldiers Dean Nilson came home on leave from Camp Funston and afterwards returned to the camp..Another young man Ernest Elliot in Haskel County visited his brother at Funston just as his child fell ill, by the time Elliot returned the child had pneumonia. In nearby Copeland on Feb 21 the local paper said most everybody there was having LaGrippe or Pneumonia..
Camp Funston was the second-largest cantonment in the country, held on average 56,000 green young troops..The winter of 1917-1918 was one of the coldest on record and the camp was famously over crowded..with bunks stacked and insufficient space per soldier. Within three weeks eleven hundred soldiers were hospitalized and thousands more needed treatment. Pneumonia developed in 237 men,,,but only 38 men died..
The low rate of death here which was only a fraction of the death rate to come indicates the first infection from Haskell was the mild form of Influenza..But influenza mutates constantly and it later mutated into its more lethal form...
So what kills you with the bad virus..The answer is three separate and different things and these can be gleaned from observation of the clinical course and put to rest some of the on going differences of opinion amongst the pundits.
The first is the virus can kill you by its own actions of invading cells from tissues including vital organs such as your lungs, heart..In these cases the virus usually targets the weaker members of the species. In humans that is the very young and the very old. It does this by lowering the lung function to the point it can no longer oxygenate the blood..Or any other vital,function such as heart function on blood circulation
But the 1918 virus mainly attacked an age group from 20 years old to 36 years old..A group who should have had the highest resistance to this form of organ failure.
In this age group your chances of dying were the highest..That can best be explained if the cause of death is not directly from the virus; but from the bodies reaction to the widespread involvement of cells..The immune system and the inflammatory system are both designed to attack these forms of invasion by foreign life forms..And they have highly effective tools for killing viruses and bacteria..The problem is the immune and inflammatory systems if over provoked begins to kill off the host..The protective systems (immune and SI) are mot active and potent in young adults and that is why the death rate was so high in this age group..It was not the virus it was the immune system that did most of the killing..
The third cause of death is from secondary infection...The virus weakens you and then you get infected by a bacterial strain..I bring this up because the COVID-19 virus lacks the innate lethality of the 1918 Influenza...and treating individuals with Chloroquine...Might inhibit the penetration of the COVID-19 into the cell...but would not treat secondary bacterial infection which is a secondary consideration that need be addressed..
So where does VASCEPA fit into the picture...Clearly Vascepa is not going to kill or inhibit the virus or protect against secondary bacterial pneumonia. Where Vascepa might turn out to be effective would be during the inflammatory stage of the disease..That period where the temperature is high..as are other clinical signs such as poor oxygenation, tachycardia...in relatively young patients..
Trying to keep things non controversial, I not much of a believer in face masks..COVID-19 is not spread airborne. The 1918 influenza was. Crowds and crowded places did much to spread the influenza pandemic.
WASH YOUR HANDS...try not to put your hands or objects your hand has touched including food or beverage containers..in your mouth..Most viruses including the 1918 Influenza are not contagious after seven days from the beginning of symptoms..
":>) JL
G.
Quote.."To avoid any doubt I did not say your are lying. I said: you are wrong, the info is false."
That is not what you said..
Quote from your post.."Why do you spread, repeat false information?"..We have a term for that in the USA..Someone who deliberately spreads or repeats false information... is a liar...
Most drug plans do not operate off the Orange book..Nor to the best of my knowledge the OB does not make cross claims concerning substitutions..The drug plans go off the FDA label and particularly the Indications and Usage...The I and U of the Gen V label and the Gen L. is the exact same wording.
From there it i just which is the cheapest...I imagine Gen L will win that race...
":>) JL
marzan...
Just more nonsense from this know it all accountant...Why would Du be bringing up the fact that the generics might infringe on Amarin's MARINE patents when she invalidated every one of them. I guess the he does not understand that once the patents are invalidated then the generics don't have to infringe on them..Because they are worthless.
I thought initially he was just pulling my leg when he said there was no discussion on the board of the generics possibly indirectly inducing infringement on Amarin's ANCHOR patents..
":>) JL
HK...
Very nice post...MD esq. "Judge" is not just careless she is a hypocrite..
I'm just saying (and I believe) there is no clear path to the generics making a fortune off the R-I indication..It's not going to be a easy as most of you including HG think..I don't expect all of you to agree and think most of you won't agree. That does not mean I am lying..Vascepa currently has two labels. I have no idea how many other FDA approved drugs have more than one label...The other fact (I believe is true) is that Lovaza and Generic Lovaza has a label where the indications and usage is identical to generic Vascepa..I also believe generic Lovaza will be be able to sell the drug at a price lower than Gen Vascepa...And because of the similar labels...State laws will consider the cheaper gen Lovaza to be the preferred drug and will convert Gen V scripts to Gen Lovaza..That will pose a barrier to prescribing gen Vascepa off label for the R-I indication..
How big a barrier and what the effect that will happen and what Amarin's legal strategy will be I can not say..But it is possible the price differential between so called Gen V and Gen L could be substantial..it is Tier based..And we have not discussed to any great degree what possible action Amarin might choose..
":>) JL
G.
I am not spreading false information...Consider the possibility you might be wrong...I am not dismissing the fact you might be right..But right now I am posting what I believe is the case and there was considerable discussion of of Du's comments regarding this on this board...
I have never knowingly spread lies or deception on the board and never plan to...And I do not appreciate your comment suggesting I am...
":>) JL
Quote: "now generics leverage is much, much higher. Difficult to settle... as I said many times, generics may actually “lose” too if appeal affirm, but they don’t care. So the mindset for H and R has always been: either amrn share the v market with them or nobody has it."
Quote: (From Big River)
"People reach new understandings all the time.
Take a sad good look..maybe change their mind."
The generics have killed it (with a little help from Du)..The question is.."Can they eat it?" I'm guessing they never spent a lot of time thinking about that. Probably they were just as surprised by the Du Fess decision..as we were..It has been my contention from the very start that winning the MARINE indication is winning nothing..
The foregone conclusion on this board is that H&R are going to be able to use the MARINE label to shoehorn into the R-I CVD event indication..Via the proviso that physicians are legally able to prescribe off label. This might have been much easier had not JD (da Judge) offered her opinion on why this might be construed as indirect infringement (of Amarin's valid patents) by inducement. The judge giveth and the judge taketh away. The generics I'm guessing will want that part removed from the DC decision.
The giant fly in the ointment is that Vascepa Marine is counterfeited by the fact that Generic Lovaza (owned by TEVA et al) will be the preferred drug for treating High trigs. And any attempt on the part of H&R to remedy that situation..E.G pointing out the CVD benefits of Vascepa..is going to end with Amarin suing them and collecting...H&R might change their minds about a reasonable settlement.
"People reach new understandings all the time.
.Take a sad good look..Maybe change their minds..
":>) JL
james...
No info on the virtual...You can't be expecting anyone at the office to help you.. You are only a shareholder...
":>) JL
HK...
Quote: "The really interesting data is in the table I reproduced, you will see that the remarkable plaque reductions."
These are not plaque reductions...These are plaque progression reductions..There is no plaque reduction..Its just that plaque progression is slowing down..But please understand the plaque is increasing...not regressing..
":>) JL
north40000
I guess life is great if you retire as a Fed...My reward for a year in Vietnam....Was GI loan which I had to file a small novel...That was gone in 1973...I'm better off than a lot of my brothers..many of who are sleeping out in the street..With some bad lingering mental problems..
But its alright..We have Judge Du looking after us..
":>) JL
james....
Totally disgusting...These execs are pigs at the sty..They care nothing about their long suffering stock holders..I do not blame JT directly for the patent fiasco. But res ipsa locitur...
Could they have done a better job at the Reno trial..I say yes..Why was the Friedewald Equation not brought up to defend non obviousness..The Friedwald Equation was the best possible reason explaining why Vascepa (EPA) would not obviously be able to lower trigs and not raise LDL-C
Example. Friedewald Equ. LDL-C equals Total cholesterol minus HDL-C minus Trigs/5....LDL-C = TC - HDL-C -Trigs/5
This universally accepted formula...clearly shows by simple arithmetic that lowering trigs must increase LDL-C if TC and HDL-C remain constant..The argument that the Friedewald Equation does not hold for higher trig levels is nonsense..All that is required to get accurate values is to the adjust the denominator in the trig factor...And the corrections are wideley known..
jf...
Its back to the old.."Reduces progression" issue..Stop for a moment and think what that term really means..It does not mean the plaque is going away or "evaporating".. Its just means the the arteries are getting worse but not as fast as without Vascepa..That probably is a good thing but it does not mean your gummed up arteries are now going to be clean and safe..Might mean if you start Vascepa in your forties you will be cutting your future risk.
VASCEPA's...main action has to be its anti inflammatory effects. And this goes to inflammation at the vessel wall and in the plaques...The idea is inflammation at the endothelial lumen interface and inflammation in the plaques themselves which bursts through the plaque cap and into the blood stream causing acute obstruction of the blood flood distal to event by platelet aggregation and other inflammatory effects..The events are so dangerous because they are so sudden.. Gradual occlusion of blood vessels can be tolerated if there is sufficient time to establish collateral circulation...Heart attacks and ischemic strokes are so deadly because there is no time to develop collateral circulation..
":>) JL
Jasbg...
Beautiful song and music..."But Brothers in Arms"...has been and remains the Amarin board music..
Compare it to your song and feel the power..
circ...
Masks might have some benefit..Eg. You are in a room with someone who has Cov-19 and he is coughing.. Then you might actually inhale the droplets..
Wearing masks inside where there are patients who have the virus would definitely be prudent..Outside of that Mask are IMO not very beneficial..In most cases the virus is transmitted by droplets which condense on surfaces..You touch the surface with your hands and then put them in contact with your nose or mouth or rub your eyes...Then you become infected..Hand washing...maintaining distance 6 feet of separation do not put your hands in your mouth...Masks are IMO only of secondary importance and some suggest they lead to people putting their hands (fingers) in their mouths...Also do not shake hands with anyone..
":>) JL
iryokabu...
Quote: "From best of my knowledge, we don't know exact mechanism of SAR2-Cov transmission. It could be aerosol, droplet, etc..
Droplets...definitely droplets. Surfaces to hand,, Hand to mouth, nose, eyes or anus
..not airborne. Why masks are not working..
Wash your hands..don't put them in your mouth or nose and you are at low risk..
":>) JL
G.
Quote: "Where / when? I am not aware of a single document that contains anything similar to this ...
It might be a rare case of Hungarian COVID brain fever..You have no recall of Du stating that the generics would be guilty of indirect infringement of Amarin's patents by "inducement" and we all sat around and learned that only physicians can directly infringe on the R-I (not invalidated) patents..Because they are the ones writing the scrips.
":>) Jl
zip...
Going for my first shock wave procedure on the 24 th this month..My doctor is the only one in the Orlando area who does shockwave and is an investigator for the company and part of the cardiac trial...
Right anterior popliteal artery...Had a conventional procedure no stent and the artery (stenosed) in the first 24 hours...
Shock wave will be the SOC for calcified arteries which are a very high percent of blockages..
Any thoughts on the patent situation..
":>) JL
Handman....
Your post is correct other than your statements regarding the API (the active ingredient)...The API can be different as is the case on Vascepa vs Lovaza..What is important is the indication and usage on the FDA label..Lovaza has the same indication (high trigs) as Marine Vascepa and gen Marine Vascepa..because the FDA label expansion (for the CVD events risk reduction). Was not granted until the last week of December 2019 and this was after the Medicare Drug plans had finalized their formularies.ie their Tier designations.
So the drug plans do not at this time recognize the R-I trial results or the fact the FDA expanded label does include the CVD events reduction..The Medicare drug plan books will open in Nov of this year..
":>) JL
marjac.
i'm not sure you need sue anyone..To begin with laws insisting on the cheapest alternative are "state laws" if you walk into a CVS in your local. You will see a large wall display..Stating that "state laws" require the pharmacy to offer the cheapest alternative which has comparable therapeutic benefit. If one exists.
In the case of the Generic Vascepa which the court determined can only be prescribed for the MARINE trig reduction..Is not going to be Gen Vascepa...but it will be Gen Lovaza...Just as it has been over the last decade before the R-I trial results were presented and mulled over by the FDA...but has yet to be added to the drug companies' formularies
For years on this board we have heard posters complain the druggist switched their script for Vascepa..to G Lovaza. And more complaints that Lovaza had more scripts than Vascepa..And Vascepa was much better..This was not because the druggist was evil or stupid..He was following the law..Vascepa at that time and sorry to say even to the present..The only FDA label recognized was/is for the MARINE indication..And Gen Lovaza has the same label indications that V had..And that is still the case at least until Nov. of this year..
The generics are going to be introduced to the same rude reality..Their scrips are going to be replaced by Gen L script because Gen L is going to be the cheaper alternative..
As far as the doctors prescribing Gen Vascepa for the R-I indication and insisting on no substitutions...Then they will be infringing on Amarin's still valid R-I patents..If that is the case then patients will be paying the "gold price" for V which will be in the $500-600 range.For three months supply.The pharmacies have to maintain records on these scripts. This data is also collected by Big Data and will be available to Amarin. And could be very damaging to the generics in a patent infringement trial...
So anyone who thinks the generics are dancing down the Yellow Brick Road...Until they win a trial against the R-I patents and there are many of them..It is the generics that have won nothing.
":>)JL
Quote:...
Judge Du did say that the generics should be careful in their marketing and actions less they be inducing infringement on Amarin's Non Marine patents which she did not invalidate..We had a great deal of discussion on this subject on this very board.
This included some remarks one of the companies (Hikma I think) made at an investor conference that suggested patient numbers that were considerably higher than the totals for the Marine indications..And this was thought to suggest H was aiming for more than the MARINE population..
":>) JL
Before anyone jumps from the bridge lets see who decides to settle before or during the Appeal's process..
I am betting it is both Hikma and Reddi...Du's decision is not going to result in the way most of us think its going to work..Gen V is going to be only indicated for high trigs..and (more bad news for R&H) gen V is not going to be the preferred (ie cheapest drug for that indication.) that's not going to be under the control of the prescribing doctor (as some of you non clinical types mistakenly think). State laws are in charge here and they say druggists must fill the script with the cheapest alternative..which has the same therapeutic indication and usage..(Vascepa and GenL have the same indications and usage for the Marine trig indication..
The federal courts (Judge Du) has decided the generics can only sell Vascepa for the Trig indication..else they are infringing on Amarin's patents..And you can bet Amarin will be notifying every drug plan out there and all the major pharmacies out there that this is the law...and they (the druggists) could be named as co parties to a criminal (federal) suit...
I know from experience individual physicians can not determine drug plan and pharmacies decision regarding issues such as Tier designations..I say that as a physician and a patient..I was royally pissed that the drug plans were not recognizing the late 2019 label expansion (The CVD event reduction indication) because it occurred after the new enrollment and drug usage period..and would not be including this indication (R-IT) until late Nov or Dec in 2020..So what happened was that even though Vascepa had the expanded label..The Medicare drug plans were only honoring the Marine high trig label and that put VASCEPA behind Gen L and meant Gen L was tier 1 or 2 an Vascepa was tier 4 and the out of pocket cost was $560 for a three month supply..
My PCP and I both appealed...but the drug plan ignored it..
":>) JL
Quote:
Not sure what value our reduce-it exclusivity has in the real world. Technically we have it but the carve out rules would seem to make it meaningless.
Exactly. Without CAFC win or without vacatur (0.01% probability) the R-IT label value is meaningless.
Best,
G
Sorry I do not agree..
I'm on the other side of the river..I think the Marine win is worthless and there is no way the generics can shoehorn their way into the R-IT indication...Not unless they can get Du's infringement opinion reversed..I also think TEVA agrees with me (why they settled for peanuts) and why H and R have not moved forward in sell for the MARINE indication..The only beneficiary I see in the Du decision is TEVA and that is because they sell generic Lovaza (GL)...GL will be the beneficiary of all those gen Vascepa scripts...
":>) JL
The transmission effect is called "passage" when it changes the structure or functional characteristics of the virus..The first host's cellular physiology changes the virus that the next next host receives..The effect can be beneficial (the virus is less disruptive) or harmful (the virus is more contagious or is more destructive or more lethal..
":>) JL
jasbg....
It's called transmission..That is these viruses can change configuration and as they pass through one host to another..The most dramatic example of this was the 1918 Great Influenza...In the early months of the year the virus was so mild that there were debates over whether there was even active virus..Then around July of 1918 the virus underwent a mutation and quickly became the deadly killer that ended the lives of over 50 million people..A great number who were in the productive years of their lives..
":>) JL
jasbg....
Quote: My personal guess is' - that had these patients been given the 'HCQ - zink (Zinc) - Z-pack' combination EARLY - most would survive - but that (very cheap) treatment is now banned by FDA in US.
Sad but true..Fauci should be tortured to death and then resuscitated and tortured to death again..
":>) JL
Chris...
Thanks for posting...
Do you have any idea: 1) where this study is being run..2)is this preventative...or is this therapeutic..(for patients with documented COVID-19 infection)?
If this is preventive I don't see how they could possibly get anything close to significance with only 1500 enrollees between now and Dec.2020.
Hopefully we are studying the effects on patients with the virus.
":>) JL
tke....
Quote: "Why did you shave your holdings down to 30%?"..
Fair question...Ans..Initially I made a huge mistake..If you go back to Du's decision...I think most of us were caught by surprise..We had been waiting day after day for the decision and it seemed like it never was coming..So I was sleeping at the switch..In by the time I became aware of her decision. The shares were between 5 dollars and six dollars.I managed to sell about 50% of my position at that level.. And later bought shares at $4...
Truth is Amarin was not my biggest position...I was still like most of you..my head was spinning..and I knew at best Amarin would need to go to appeals and that was going to be another crap shoot.
I had pretty much the same reflexive view that most of you had and still have...But over the course of time I began to understand that the Generics were not going to do the Merry Widow Waltz into the R-I indication..and that Generic Lovaza was going to be a huge impediment to them in making any money..And I think TEVA (who sells gen Lovaza) knew that and that is why they settled for peanuts...
I am currently very bullish on Amarin..and believe I understand the situation better than almost anyone who is not TEVA or the unfortunate Generics...
But I do also like another issue other than Amarin...
":>) JL
tke....
Quote: "Why did you shave your holdings down to 30%?"..
Fair question...Ans..Initially I made a huge mistake..If you go back to Du's decision...I think most of us were caught by surprise..We had been waiting day after day for the decision and it seemed like it never was coming..So I was sleeping at the switch..In by the time I became aware of her decision. The shares were between 5 dollars and six dollars.I managed to sell about 50% of my position at that level.. And later bought shares at $4...
Truth is Amarin was not my biggest position...I was still like most of you..my head was spinning..and I knew at best Amarin would need to go to appeals and that was going to be another crap shoot.
I had pretty much the same reflexive view that most of you had and still have...But over the course of time I began to understand that the Generics were not going to do the Merry Widow Waltz into the R-I indication..and that Generic Lovaza was going to be a huge impediment to them in making any money..And I think TEVA (who sells gen Lovaza) knew that and that is why they settled for peanuts...
I am currently very bullish on Amarin..and believe I understand the situation better than almowt anyone who is not TEVA or the unfortunate Generics...
But I do also like another issue other than Amarin...
":>) JL
tke....
Quote: "Why did you shave your holdings down to 30%?"..
Fair question...Ans..Initially I made a huge mistake..If you go back to Du's decision...I think most of us were caught by surprise..We had been waiting day after day for the decision and it seemed like it never was coming..So I was sleeping at the switch..In by the time I became aware of her decision. The shares were between 5 dollars and six dollars.I managed to sell about 50% of my position at that level.. And later bought shares at $4...
Truth is Amarin was not my biggest position...I was still like most of you..my head was spinning..and I knew at best Amarin would need to go to appeals and that was going to be another crap shoot.
I had pretty much the same reflexive view that most of you had and still have...But over the course of time I began to understand that the Generics were not going to do the Merry Widow Waltz into the R-I indication..and that Generic Lovaza was going to be a huge impediment to them in making any money..And I think TEVA (who sells gen Lovaza) knew that and that is why they settled for peanuts...
I am currently very bullish on Amarin..and believe I understand the situation better than almowt anyone who is not TEVA or the unfortunate Generics...
But I do also like another issue other than Amarin...
":>) JL
ilove....
Excellent post..The generics are not nearly as well positioned as some of you suggest..So far it is not really clear on what they have won and will have won even if they prevail in the appeal...
Some factors for consideration...Generic Vascepa (the MARINE Indication) runs into the hard cold fact that Generic Lovaza will be the preferred drug for the MARINE indication..(why??..It's cheaper and it has the same "Indications and Usage" as Vascepa for the MARINE indication)..
Forget about the CVD "R-I" indication...Amarin can track usage and indications. and if the Generics attempt some "funny stuff." They will be looking at a huge law suit for infringing on Amarin's patents .They will also be in trouble by breaching a federal judgement.
Teva settled very early for peanuts and I believe they got it right..I think the generics will be clambering for a settlement here..If there is any opposition to it. It will be from Amarin..
The only thing I am unclear on is whether a settlement in the Appeals Court will automatically mean the DC will vacate Judge Du's opinion that the patents are invalid..That could be an overhang...Amarin might not settle if the patents are still considered invalid as this could led any number of other generics to go after the MARINE label..
The important thing to understand is The MARINE label is pretty much worthless..but the R-I label is where the big money is..(could be one of the most valuable labels in medicine)..The idea the clever generics are just going to swoop in and grab that indication by off labeling is not going to happen. Yes the general rule is doctors can write scripts off label...But generally speaking there is no federal ruling that saying they can not. In this case even Judge Du stated the generics would be inducing infringement if they marketed for the R-I label..But it does not matter...By the law Generics can only prescribe for the MARINE (the high trig) label..And because of this the pharmacies abiding by state laws will substitute generic Lovaza...because it is preferred.(cheaper)..Any attempt on the part of generics to market or educate the pharmacies or states..And they will be facing a federal suit..
Conclusion 1)..The generics best strategy in this case is to settle..even settle for a small sum.. Little is always bigger than nothing...
Conclusion 2) The generics are SOL....
":>) JL
Ray...
I'm sure what you posted is crystal clear to you. Sorry I can't follow your thread..Your post might seem simple to you..and maybe to a lot of posters on the board. but not to me..
When I look at this problem..I don't worry about 25 cent increments on the PPS based on presumed probabilities..These are no more than wild goose guestiments on your part...IMO the best anyone can do is look at the global effects..That is what happens if Du is reversed, What happens if she is affirmed. Is this a good bet on our part or should we just sell our shares and move on to another stock..
What you should glean from my post is simply that regardless of the odds of Du being reversed or affirmed..We are more likely to win more money if Du is reversed than we are going to lose if Du is affirmed. Anyone who thinks the odds are in the 50/50 range or that Amarin has a 30% percent or higher chance of winning the appeal. This is a good asymmetric bet.. Win big, lose small..KISS...If you think Amarin has no chance then you should sell your shares before the verdict.
":>) JL
Handicapping the trial....
The stock market is about gambling. My college roomate's father was Howard J. Samuels who was the first Commissioner of Off track Betting (OTB) in New York..Called "Howie the Horse". He was very progressive and ran ads in all the papers with headlines like "have a cup of coffee and a daily double"..He also had the temerity to compare the horse track to the Stock Market and that drew the ire of the Chairman of the NYSE...Samuels replied "Yeah watered stocks don't get the saliva test...
Looking at the upcoming Amarin Appeals trial...It is essentially a binary event because the likely outcomes are either Du gets affirmed or reversed..Because her errors were primarily procedural with couple of factual error thrown in..a remand is unlikely..(she could be made to repeat third year of Law School)...
So what are the implied odds..We are currently at a PPS of 7$...This is a very unusual situation where the PPS reflects almost solely the effect of the Du.. decision..The drug itself has not lost its therapeutic value or its potential market...It is perfectly reasonable to estimate if Du is reversed the PPS will climb back to the pre Du PPS of over $21..That represents a 2:1 return on your bet..and that assumes if you lose the price goes to zero...The reality is the PPS is very likely to return to the 5$-7$ level..since the current 7$ level represents a heavy discount on Du's decision and fails to adequately account for the large markets that Amarin still holds and will be able to hold..The important thing here is do not sell your stock if Du is affirmed..Its going to sting if that happens but it is not going to be long term fatal..
If Du is reversed the stock will go above $21..and you will be getting 2:1 on your money..So if you think Amarin has a 33% chance of winning the appeal you should be betting the farm..Particularly if you understand that if she is affirmed you will still be getting most of your money back provided you do not panic and sell immediately after the decision is announced...
":>)m JL
An old friend of mine one of my golf buddies was a patent lawyer..and he said no patent is truly valid unless it has been challenged in court and won..
We might actually be lucky..Reminds me of a story of an infantry fire base in the central highlands in Vietnam..They had a single runway..Every morning an NVA sniper took a shot at the helicopter delivering the mail and had for the past six months..At that point the commanding officer of the fire base was relieved because his tour was up..His replacement was a young
Capt...a gungho West Pointer..
The new commander heard about the sniper and sent a recon squad out and they found and shot the sniper..A week went by and the next morning the sniper's replacement arrived. He turned out to be a better shot and on his third day he shot downs a Shinook with twenty six infantry and the crew all perished..in the flames..
Sometimes a sniper (Du) that can't shoot straight is a blessing in disguise.
":>) JL
slim...
I'm thinking Taas is the next big thing. Think bigger than the internet eventually..Self driving electric cars owned by huge corporations..You get an account and send the what time and where, and off you go..No gas guzzler in the garage hanging out for fourteen hours a day..No more crazy human drivers whacked out on weed or inebriated..
Computers can do it faster than humans..and that's what you need when you are traveling the highways..No more car insurance...Electric cars are more reliable..Motors are more reliable than engines..(And i drive an NSX) motors can do a million miles no sweat..ten years from now they will not let human drivers on the highways..
Its already being done in Phoenix, Las Vegas..and starting in Boston and other major cities..
Who does it..Look up APTV...
Happy trails..
"":>)JL
circ...
About 30%..enough if Amarin prevails to make a lot, but not to get killed if the Du gang steals the company..I am appalled at how irrational the whole legal process is..and how poorly the company has defended its property..
For example they're first line of defense should have been the Friedwald Equation..since the novelty and significance of Vascepa was its ability to lower trigs and not raise the LDL-C..
The Friedewald Equation was an indirect way to measure LDL-C levels which were difficult to measure directly...LDL-C was for a long time considered the most (and frequently the only) recognized surrogate for CVD event rates..
Friedewald said....LDL-C*= Total cholesterol -HDL-C (high density ...................lipoprotein cholesterol) - Trigs/5..
Yes it is true that this equation is not completely accurate over a very high or very low range of trig levels..But to get very accurate levels all that needs be done is to correct the 5 denominator under the trig/5 factor to arrive at the correct measurement..
If you look at the Friedewald equation you will see if the trigs are lowered and the TC and HDL-C remain the same,,then the LDL-C has to increase. And this was confirmed by the fact that all drugs that lowered Trigs also increased the LDL-C (bad cholesterol)..And that is why the fact Vascepa (EPA) lowered trigs but did not raise LDL-C was a surprise and was in no way "obvious"..And why Du's opinion was 100% incorrect.The tragedy is that none of Amarin's so call experts informed Judge Du of this simple fact..Instead she based her opinion on trivial and insignificant information from trivial and insignificant trials..
":>) JL
* so called bad cholesterol
Du's opinion....
The flaw in the Death Star..
Can we agree that being a good doctor does not mean you are a good lawyer and vice versa..Good legal decisions are like good houses..They need strong foundations..The problem with Du's decision is the foundations are virtually non existent. What are her foundations? They are MORI and Kura..two obscure papers published in non peer reviewed journals..Trials which were not designed or powered to prove anything based on scientific rigor. The only thing supporting them is Du's authority as a federal judge... A simply "Because I am the Mommy" argument...
Its been a long time since 2012...My memory is not as good as it use to be..but I believe it was the 889 patent..The one covering the trig lowering without raising the LDL-C and the patent examiner had declared the patent invalid because it was obvious. I wrote the USPTO a reply that included the facts about the Friedewald Equation and how it predicted that lowering Trigs by any method should (must) increase the LDL-C and they reviewed the patent and validated it..
The facts have not changed..The Friedewald Equation is still considered valid in all circumstances. The reality is that EPA seems to be a lone example where the Friedewald equation does not hold..This makes EPA's actions anything but obvious..We really don't know how EPA gets around this seemingly unsurmountable barrier..My own theory is that the anti inflammatory (SI) actions of EPA produces a statin like effect which lowers Total cholesterol...
The salvation for Amarin lies in explaining the ramifications and the strength of the Friedewald equation..It is the foundation of blood lipids physiology...and it clearly proves that Vascepa's actions were not predictable or obvious..
":>) JL
HK....Re: Silbersher...
Quote..."Yet, the problem that Amarin now faces is that it is no longer trying the case to a fact-finder. Rather, the case is on appeal. Amarin’s contention that scientists did not expect pure EPA to be LDL-C neutral in severe patients is not the issue. The issue, rather, is whether Judge Du’s finding that it was expected was clear error."
I don't see where this is a problem..Facts were and still are the Friedewald equation predicted that trig lowering by any method (including
EPA) should increase the LDL-C..And though the Friedwald equation is normally considered accurate for Trigs under 500Mg/DL..A real POSA would know that any error in the Friedwald equation related to trigs over 500 can be corrected by altering the constant 5) under the trigs/5 factor.
The Friedewald Equation has been proven accurate in studies involving more than 25 thousand individual measurements and like the speed of light, is not subject to opinion..At the time of the Amarin patents the Friedewald Equation was widely used and known to be accurate. And the Friedwald indicated any drug which lowered Trigs must increase LDL-C
The Friedewald Equation...LDL-C = Total cholesterol - HDL-C -trigs/5 the friedwald equation is accurate over a wide range of triglycerides with the proviso that at very high trig the denominator of the trigs/5 estimate must be changed to accommodate the higher trig levels. The Friedewald Equation was introduced into medicine in 1970s was in widespread use during the Amarin patents. The Friedewald equation clearly indicates that any drug that lowers Triglycerides must increase LDL-C if the drug does not substantially increase total cholesterol.or decrease HDL-C. Which neither DHA nor EPA did....So arguing that EPA was expected by anyone at the time of Amarin's patents to be able to lower trigs and not raise LDL or thought it was obvious is dead wrong..There was no expectation that EPA had a statin like ability to lower Total cholesterol.And to this very day it is difficult to understand how EPA actually does manage to lower trigs without raising the LDL-C fraction..And that was why the patent office granted the patents..
Hope this helps...
":) JL
N.B...At the time of Amarin's patents circa 2008-2015. All framed opinions about the effects of drugs on blood lipids would have taken the Friedewald Formula..(equation) into consideration and that is like the Speed of Light.."Not subject to opinions"..No POSA would have predicted EPA's special attribute..And no POSA would have considered Amarin's patents as obvious..
James...
This is a possible result.. The judges might circle the wagons. That would be the final irony..Hopefully the Circuit Judges will remain objective..And make their judgement of based on Du's non stop bad behavior.
":>) JL
HK...
Absolutely priceless.."I laughed..I thought my pants would never dry."
I am gradually exiting stage left of the Amarin farce as I can not deal with the idiotic scope of these judges and lawyers..My world tries to embrace logic, fact and reason..It seems the legal system is an "Alice in Wonderland world" with Du being the Red Queen...The judges are the "Walrus and the Carpenter" and who are we..We are the Oysters..
None of these judges apparently have sense enough to pour piss out of a boot..
":>) JL
I like the fact that on Inseego's extensive rollout they mention Autonomous (Driverless) cars as the first example of where they are heading...
I like that very much because electric and driverless car are definitely in the future story..(And I am a guy who drives an Acura NSX) It pains me to think my car that cost $180 K counting sales tax will likely be a dinosaur five years from now..And may not even be legal..
Electric cars which were merely a curiosity five years ago; will soon be mainstream..They are cheaper to run, have motors rather than engines which are several order of magnitude more reliable, They do not pollute the atmosphere. And can beat anything on the road from zero to sixty..Five years from now Taas (Transportation as a service) will be the reality..You will not own a car anymore than you would own an airplane or a helicopter. Right now most planes are owned by companies that sell tickets to passengers which means the planes are in the air making money most of the time..Think about it..Unless you are a traveling salesman most of the time your car is parked somewhere..Costing you money but not bringing anything into your bank account..Uber, Lyft or any of the pioneer company's that ferry you around or fetch thing for you are using the car the way it should be used..In five years the average car will be in use over twenty hours a day which leads to the second issue..Autonomous vehicles..
Autonomous vehicles: Uber is almost perfect..and would be even more so if Uber did not have to pay the drivers..Autonomous cars (ACs) do not have to pay expensive humans..Are going to be safer drivers than humans (sorry about that you lawyers out there.) Always show up for work..Do not assault the ladies. Do not drive while under the influence..You want to go somewhere and comeback (alive) use an AC..You will have a account..just punch in and off you go..
ACs are like VR...you need close to zero lag time to make them work correctly..That is where 5 G comes in..If the cars do not need to park then we can get rid of parking lots which take up an amazing amount of urban space..
Most of the possible Taas ideas are big corps with big share prices..I know now that INSG is targeting the taas market because it was the first thing mentioned. In their promo Was ACs...I'm thinking how lucky we might be if a little INSG device was sitting in some. most or all ACs..
":>) JL
barny....
Wow..This looks like something out of a Gibson novel...Neuromancer...
This is the most impressive promotion that I have ever seen..I have been looking (searching) for an entry into the Taas (Transportation as a service) concept that does not require investing in triple digit dollar priced stocks like Tesla, Amazon or Google..
INSG looks like the one...And we are in it while it is affordable..
":>) JL