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circuitcty...
I don't understand your message..I understand the strategy I am suggesting is not perfect. Yes the generics can drop their prices, but Amarin currently has enough suppliers (producers of FDA grade EPA) to insure that generics will not be able to reap landfall profits from selling generic V in the USA...I like the term Walmarting...Yes the generics can apply a counter strategy using the profits of their drug pipeline..But Amarin has Europe and the generics do not..
I am not sure the fact Hickma got their ANDA approved "pretty fast".. Means that manufacturing the drug is not tricky. Hickma did not need tons of EPA to get the ANDA approved..Plus I believe Hickma applied for the ANDA a number of years back..(G can correct me if I am wrong)..
You are correct in saying my strategy is far from perfect...Right now we need to GTO (Game Theory Optimize) and anybody who thinks they have a good strat is welcome to expound.
Time we get proactive..Everyone agree we need "Lobbyists."?.Can we get on Sixty Minutes ? Is there anyway to get Trump's attention?? We have a lot of smart people on this board..how about some positive ideas. C'mon
":>) JL
The book.."A Night to Remember" (later a classic movie)..Is about the immediate events on the RMS Titanic. On April 14th and 15th in 1912. The opinion for many decades was the Titanic struck an iceberg which caused a large "hole" in the hull..What was learned from the later finding of the actual hull..was there was only a small 12 to 13 foot gash on the starboard side. This put a strain on the surrounding hull which was held together. Not by "best/best rivets, but by best rivets in the bow and stern which were cast iron and had areas of slag..
In the book the crucial point is when the captain of the Titanic calls the ship designer Thomas Andrews who is a passenger to ask him if the Titanic might sink....This is within minutes of the collision..By that time the Titanic has taken 13,000 tons of water and this is flooding at a rate of (7 tons/second). The lower portion of the Titanic is divided into 15 compartments designed to prevent mass flooding, but as the hull takes on water it pulls the involved compartment down and this allows an overflow into the next compartment..and so one..Since the Ship can not bale at the rate the ship is taking on water the captain asks Andrews if he thinks the ship will go down..Andrews says something like "In ninety five minutes...The rest is history..
The lesson from the Titanic was it is sometimes the little things that cause the biggest problems...The Ocean was not the problem..the sea was described by survivor as being like glass reflecting the stars perfectly. The collision with the iceberg was only a minor scrape...Ships like the Titanic have sustained injuries to the hull from from collisions from submarines and did not go down..The hull breach apparently was along the stress line of rivets which were not reliable and they could have failed like Brady's pants..A situation that could of occurred without the iceberg...
The huge mistake in Amarin's case is their (and Covington's)..the "faulty rivets"... is deciding to try the case in the ninth district..Their legal representation should have fully apprised them that the biggest risk was the Judge. And at that point they should have immediately ruled out the ninth district..The last thing in the world the company needed was to concentrate on patent law which has the highest BS quota of of any subject in law. That is why patent law has its own bar...What should have happened is they should have been arguing property rights..and not some crazy patent law which is based on "plow design".
Amarin is the craziest stock I have ever seen..It's made some of the greatest, balliest moves of any stock ever then followed them up with mistakes that would embarrass a moron..And in my opinion, the fact Covington signed off on this, is a black mark on their record..A real bone head play...
What can they do now??? Well they could win the Appeal..but that is not a sure thing by any stretch..Amarin needs to Game Theory Optimize the different strategies..The undeniable fact is the market here is stupendous (think Coke can live with Pepsi)..This is going to be interesting if the appeal fails..Right now drug rules are set by state laws as far as scripts are concerned and the decision in virtually every case is the criteria of cheapest price. Not just generic..And the first thing Amarin needs to do is to notify every one of the drug plans that they intend to sell the drug to the plans at a lower price than the generics and they want the lower tier even if they are the brand..I know that flies in the face of all conventional thinking it is in line with the Vascepa is a volume play and not price play..
Can this actually be done?..I don't know. but I like it as a "dog in the manger" strategy..If we can not win then neither can you..I know generics can defray V costs by using their other drugs...But that really does not add much to their bottom line and EPA is a tricky drug to deal with in terms of production purification and stabilization..It stands to reason Amarin can produce the drug cheaper because it has agreements in place..
Amarin also will hold the rights to other areas free from Du's terrible ruling..Most importantly Amarin will have Europe..I remind everyone the population of Europe is over 700 million and the USA is only about 320 million..If Vascepa could treat one tenth of the European population 70 million patients.. AMRN PPS would be north (way north) of $1,000/share. The generics do not have any in roads into the European market for the next ten years..
We need to look away from the USA and cast our focus on Europe..That is where our current future lies...
":>) JL
zman...
I can hardly guess what the conclusion was...
":>) JL
Play in the scam...
I think you pretty much cover the bases here..Used to be in America if we owned something and the government did not take it by "Eminent Domain then we need only to part with it if we agreed to sell for a given sum of money or goods..
That was in pre DU America...
":>) JL
Meow..
Couple of facts for you..First of all your message was a reply to my earlier message..You took it on yourself to educate me. You have been posting on this board for a few months and from your tone you must think the rest of us are morons ..Regardless of the fact you don't like my credentials...I was posting on the physiology of EPA before you ever heard of it..And everything I predicted came true..You may be dismissive of my credentials. I look forward to you educating us to your credentials..
You think I don't know EPA was the only AI that lowered trigs and did not raise LDL-C levels? I responded to the USPTO to the first rejection of the 889 patent..The problem was the PTO examiner made a math error. I corrected that and the patent office issued the patent..That was on the Yahoo board... When I told the Yahoo board the PTO examiner made a mistake..Posters were rolling in the aisles..Turns out the PTO agreed with me. and reversed their opinion. Don't believe me check it out with KIWI..AKA "Whalatane" he was there.
Sorry I don't agree with your post..The conjecture I was talking about your conclusion that Du was apprehensive..She blew up Amarin without a care in the world..
Far as I can tell you are all mouth..no back-up.and feel free to "sit on it"..Whatever that means...
":>) JL
Meow..
The first thing I learned at MIT is "Obvious" is purely subjective..Adding a bunch of terms like Objective indicia is just BS.
Quote: "Why was Judge Du apprehensive about taking Amarin's patents objectively, I wonder."..That is only your conjecture..Please speak directly and don't try to be so "cute"..
The problem with Du is somewhere along the line she dropped the mantle of impartiality and decided she was going to give the generics Amarin's property..We could speculate for days on her motivation. As far as I know we are still a country that respects private property and recognizes individual endeavor...So the question is..Has Du presented any facts or reasons why Amarin's property should be given to the generics..Or put another way..Have the generics done anything that gives them the right to Amarin's private property..
As far as patents are concerned..The only justification I could imagine that would give Amarin's rights to the generic is if Amarin was infringing on the generic's patents..And so far we have heard nothing about generic patents..
The H-W legislation needs an overhaul..Filing an article 4 (patents are invalid) claim should require clear and overwhelming evidence the patent(s) are invalid..and the burden of that proof should fall on the challenger. (the generics) and should be based on information at the level the PTO made a serious mistake..ignored a previous patent..but not because some lameo DC judge who thinks we should follow Russia's example. Thinks the patents are obvious..
If the AC affirms Du...The drug industry, the medical community and the USA are going to be hurt..Bad enough the lawyers already use clinical medicine to subsidize their existence via malpractice lawsuits (which raise the cost of medicine by 45% due to defensive medicine and settlements)..This is tacked right onto the cost of healthcare. Affirming Du is going to have a chilling effect on the whole medical research industry and will directly slow the process.
People ...Important people should be taking a serious look at this Amarin situation...
":>) JL
circ...
I have never discussed GIA with JT..I do agree JT has made mistakes and I am unhappy with the way JT is always helping himself to Amarin's money...
That said...I think some of the things that have happened to Amarin are not JT's fault..The Amarin story is beyond most peoples imagination. And would have stretched the abilities of Henry Ford or John D. Rockefeller. He did successfully complete the R-I trial which is a bigger accomplishment than any other Biotech or BP CEO in recent history..
We don't have complete information on the recent V. action...Including the Reno disaster..We don't know whether or not the two generics were interested in a settlement TEVA did settle..
If you had a better answer Amarin had for the Du decision..Then maybe you should be the CEO..I have always been surprised at all the opinions that BP is the answer to everyone's problems. I have been trading stocks for 60 years and I have been present for several takeovers..What is true is that shareholders do frequently see a wind fall..But it is not always beneficial for the company being bought out..In Vascepa's case V might become just one of the drugs and not the most important one..
If we know anything about Vascepa is it requires full time attention..A BP with its own projects might just throw up their hands and say. This is not worth it and just cut the chord...
If you are looking for a quick score then yes..Sell the company..but if you want to own shares in company that will be able to print its own money..then you want shares in Amarin..The road may not be smooth or certain..But if we prevail you will never have to own another company the rest of your life...And yes I know the road has been brutal..I've been in the company since late 2010...
":>) JL
circuitcity...
You are welcome to your opinion..I have always been GIA avocate..sorry I'm such a dumb-ass and not up to your standards..
":>) JL
Bolio98...
Yes SCOTUS...but believe me we don't want the case to go above the AC as the SC..The judges there are even worse...
":>) JL
ilvetech...
IMO Amarin's strategy has argue unintended consequences. The generics' attack here is on the crucial weakness in the H-W legislation..And that is the patents..Obviousness is a subjective term..Regardless how the legal system tries to coral. It still remains subjective..Put very simply what Einstein might consider obvious an average person might not even comprehend..The legal definition of obviousness is based on a novel design for a plow. I think that says a lot about about obviousness and the law..
H-W needs to be amended and the nullification of patents in NDA cases needs to be removed..The USPTO's opinions on patent issues such as obviousness need to be decided once and for all at the time the patent is granted. Once in the Orange Book..The patent should no longer be challenged. For God's sakes we spend all this money on the Patent office and the FDA..Then we get one mentally challenged DC judge that can come in and blow the whole system up.
We need the system to go forward because we have not solved all the problems in medicine..We still have Alzheimer's and vascular disease is still an issue as I know from personal experience.Cancer, clinical depression to name a few..The drug industry is going to look on this Amarin debacle and the message is going to sink in..We have far to many drug trials and new drugs that fail at the FDA level..I remember reading success was only in the teens..
Drug innovation is the wildest form of gambling...The dice are loaded from the beginning...and if Du's opinion is upheld it is going to shake the entire foundation of the Drug industry and we are going into an "Ice Age" and no one is going to be bringing new drugs into the FDA "marketing process"..
All these fat ass BP execs are currently waiting on the sidelines of the Amarin Trial and thinking "glad this isn't me"...But a win here by the Duists is going to put everyone on alert..and taking "one in five" shots on new drugs and then having to worry about the crazy legal system..Giving their drugs to generics is going to be the end of the drug industry..A "Catastrophe"...
I say the problem is not in the drug industry..It is in the legal system..The legal system currently uses medical malpractice as its cash cow..Everyone who studies the problem understands that Med Mal is a scam..Medicine is defined by complexity and errors are essentially unavoidable..Even the serious and obvious ones..A good analogy is the game of golf..Golfers know the best strategy is the obvious one..down the middle..on the green and 2 putts..The problem is regardless of the fact professional golfers can make millions by doing just that..The best golfers in the world hit the ball out of bounds..miss the green..land in the water..and miss three foot putts...But when it happens to a clinician it could result in a huge malpractice suit..Numbers here on who gets sued...Its the clinicians that do the most operations, see the most patient..If you are a surgeon and don't want to get sued..Don't do any operations..
This Amarin case is no harmless event...This is Armageddon..BP better start reaching in its pockets and buying some influence and get rid of this stupid trial because it can pull them right down in the sand with Amarin...
":>) JL
TTE...
Quote: "If you eliminate Dyk, you remove a huge blocker from a reversal. And it would reduce the chances of getting the two remaining patent super-unfriendlies down to near nothing!"
I like it. Straight out of Modern Poker Theory..Based on GTO principles...
":>) JL
Quote:
Americans for Pharmaceutical Relief Act
America must strive for innovation and leadership in the field of medicine and pharmaceuticals. The Hatch-Waxman act, while well intended has actually increased pharmaceutical expense and risk to innovation. This places American lives in jeopardy. A pharmaceutical company can file and receive a patent(s) from the USPTO and complete an expensive clinical trial where hundreds of millions of dollars are spent to prove the safety and efficacy of the drug. According to an MIT study, only 14% of drugs taken through clinical trials receive regulatory approval. If a drug is approved in the US, foreign generic suppliers can apply for approval to the FDA under Hatch-Waxman and the pharmaceutical that invented the drug, bore the expense of the clinical trial must defend the patent in court or have their innovation stolen by the foreign generic. To avoid a trial, many pharmaceuticals settle with the generic company and that cost is passed to consumers. Companies settle rather than run the risk that judicial activism can strip them of their innovation. Those that do go through trial must pass the cost to consumers. The cost, and risk to a pharmaceutical hinders innovation and increases the cost to consumers. The act is a means to bolster Hatch-Waxman by providing innovators alternatives that resemble some of the regulations in Europe."
I don't speak Lawyereze..but this paragraph sounds very strong to me. It is said if you wish to call up a demon: you must first learn his name..In this case I see many names "stupidity" (on the part of Du) There is an old saying; "Nothing is as frightening as ignorance in action."is Du really all we have in the Judiciary. An affirmative action example of how someone exists in the murky ground that separates the law from politics. "Connected" I believe is the word..Interestingly enough it has the same meaning in La Cosa Nostra...The word I am looking at is Arrogance..The most amazing thing to me is how this women who was not even born in the USA can boldly put herself in front of both the FDA and USPTO and say she knows more about drugs and patents than they do put together..when it is clear she is incapable of even reading a Medical Journal and getting her information correct..
The problem is not with her,,The problem is we let her and her fellow judges run over us because they are wearing black Robes..Is there nobody willing to call Bull Sh*t on this whole charade. This can not be right... Are we all morons that we watch this arrogant bullsh*ter..throw learned opinions out the window because she is a judge. This is not "Justice"..This is farce..
.Why are we wasting billions of dollars running the FDA to evaluate drugs as to their safety and efficacy. If all it really takes to approve a new medication is an an OK by Judge Du. Why do we need a patent office stuffed with expert when Du the almighty can throw six or seven patents out with a wave of her arm and wink of her eye..Why are we blowing all that money when the solution is so clear...
Why are we putting up with this..are we that brainless...I'd like to see these judges pass a state medical licence exam. Before they made such momentous decisions..Barring that..I feel they are stealing my money and are nothing more than thieves in black robes..It.s a con game and we are all the dupes...
":>) JL
Where Evofem might really hit a home run is if Chlamydia turns out to be susceptible to the PH changes their drug produces..That would be a lifesaver..Center for disease control reports that Chlamydia may be asymptomatic in as high as 95% of women..Chronic Chlamydia can lead to PID (pelvic inflammatory disease) and sterility..Chlamydia is spread by sexual intercourse...
":>) JL
sstyles,
I'm with the KIWI on this one...I would not rule out some dirty dealings in the DU decision (alliteration). But believe me it doesn't involve stupid Stevie the shower stall styler..
I know that most of you on the board were either too young to have spent a year in Vietnam, "Where gracious living and combat pay go hand in hand"..Or smart enough to have figured out a way not to be called up..
Kiwi...
There was absolutely no evidence. Suggesting the medical community or the FDA or the USPTO...Thought EPA was an obvious as a cure for Acute Pancreatitis or atherosclerotic In the 2008-2010 period..EPA had virtually no fans..
I began to get the idea back in 2010. Not from my knowledge of lipids or CVD..But my background in Systemic Inflammation and that was from my close association and being the clinical adviser to a group of scientists at Harvard that were working on ideas to control inflammation..
I felt the jump from lipids gumming up the arteries like sludge in a sewer pipe might have thrown a lot of people off and the possibility that the real issue was damage to the arteries from inflammation and knew that EPA and the EPA/AA controlled Systemic inflammation in the Eicosanoid system..The problem there was not a lot of interest in the medical schools on the Eicosanoid System. Medical students and clinicians knew very little other than names like "Prostagladins..But the the whole topic was mainly a medical scientist thing..The clincians did not know the science and the Scientists did not know clinical impact..
So it was like the A-Bomb explosion at Trinity...Einstein might have predicted the mega effects of losing a small amount of matter in the fusion trial...But nobody thought it was obvious the bomb would explode the way it did until Trinity...After the explosion..Then it was obvious"...
The 2018 R-I trial results of the Vascepa were the Trinity explosion..The EPA's effects became Obvious..But not before.
":>) JL
The Irishman....
My sympathy and I'm certain the rest of the board go with you for little Mario..
Perhaps you might take comfort in the fact..Fataliies from the the COVID-19 virus in that age group are close to zero..Its going to be more like a cold..There is nothing more frightening than a sick child..I know from experience..I went through it with my son Chris 37 years ago and I still remember the fear...
":>) JL
TTE,
Nice summation...No question she obviously had an agenda and was not judging impartially...Lets hope we get a better shake down the road in DC...
":>) JL
How Pure EPA might be able to lower Triglyceride and not cause a rise of LDL...A new hypothesis..
At issue unlike Du's conclusion that a POSA would think it obvious to use EPA to lower Triglycerides because EPA would not increase LDL levels..ACTUALLY a POSA would think it obvious that EPA (like all other trig lowering therapies) would obviously increase LDL..Since DHA, Niacin, fibrates all increased the LDL levels.
More to the point..it was well understood why Trig lowering would increase LDL-C and this was substantiated by the Friedewald Equation...
The Friedewald Equation LDL = TC(total cholesterol)- HDL-C(high density lipoprotein cholesterol) -Trigs/5..
.The Friedwald Equation has proven its validity in a trial,of more than 30,000.measurements The Friedewald equation has been criticised for being inaccurate for very high trigs..But the reality is a these inaccuracies can be avoided by a simple correction of the Trigs/5 factor..
The importance of the Friedewald equation was well known before and during the MORI and KURA trials period. The simple arithmetic of this equation makes it perfectly obvious that if the TC and HDL-C remain constant then any lowering of the trigs must result in a higher level of LDL..And that would have been obvious to both Mori and Kura. So arguing a POSA would predict EPA would lower trigs and not raise LDL is factully incorrect..A POSA would think it obvious that if EPA lowers trigs it must also raise LDL..
And actually in addition to the Friedewald equation..The molecular activity which leads to the conversion of Trigs into LDL-C was understood..The Lipoprotein that transports trigs in the blood stream is VLDL..(very low density lipoprotein) and this protein is principally APO-b..Which is a protein which also transports LDL-C...
VLDL (being made of APO-b transports both trigs and cholesterol) Normally trigs are the biggest fraction..but if trigs are lowered by more than 50% in the VLDL protein packet..Then the VLDL is converted to LDL-C..So definitely a POSA at the time of Mori and Kura would have considered it obvious that trig lowering by any means, including EPA, would have to increase the LDL-C levels..And not what Du thinks..
To this day it remains a mystery of sorts as to why pure EPA alone can lower trigs and not increase harmful cholesterol..It is still not obvious.
My hypothesis is that this special effect of EPA is the result of EPA's special ability to lower Systemic Inflammation (SI). What is understood today is that trig levels reflect not so much dietary intake or liver production...But are regulated in a similar fashion to way blood sugar levels are...And that is by controlling the rate of removal. We are more familiar with the effects of insulin on controlling blood sugar..Insulin activity increases the removal of sugars (which are fuels like trigs) from the blood and stores them in the adipose tissue and we should not be surprised if trig use similar methods...The key here is that Systemic Inflammation (SI) elevation causes Insulin Resistance (IR) and IR weakens the ability of insulin to lower blood sugar and store it in the fat tissue. Triglyceries have their own brand of Insulin which is called Fatty Acid Synthase (FAS)..and its potency is like Insulin is diminished by high SI...
A plausable reason why EPA alone might be able to lower trigs and not raise LDL-C i due to the fact that EPA alone effects SI levels..This is not controversial..It is well known to scientists who study SI,,just not well known to cardiologists an lipidologists..EPA's effect might operate to remove trigs by FAS while other agents,,Fibrates, niacin, or DHA Which lacks the correct 3 dimmensional structure to interact with the eicosanoid cell membrane receptors that are the major controllers..of systemic Inflammation..EPA...By lowering SI could lower trigs the physiological way by increasing FAS activity and that might not increase LDL as much as the non physiological removals by other drugs..
If we, including epidemiologists, cardiologists and Diabetes specialists..recognized the similarities between trig control and diabetes..Then things might be understood a little better,,We should be thinking Trigabetes.
I do not envy Judge Du having to consider all these complicated issues in lipid and inflammatory and can understand how she came to the wrong conclusion..There is no way in 2000 or even ten years ago a POSA would have reached the conclusion that DU reached...
It would be like me that has a background in Engineering and clinical medicine would have troubled with the nuances in a complicated patent issue..
":>) JL
How Pure EPA might be able to lower Triglyceride and not cause a rise of LDL...A new hypothesis..
At issue unlike Du's conclusion that a POSA would think it obvious to use EPA to lower Triglycerides because EPA would not increase LDL levels..ACTUALLY a POSA would think it obvious that EPA (like all other trig lowering therapies) would obviously increase LDL..Since DHA, Niacin, fibrates all increased the LDL levels.
More to the point..it was well understood why Trig lowering would increase LDL-C and this was substantiated by the Friedewald Equation...
LDL = TC(total cholesterol)- HDL-C(high density lipoprotein cholesterol) -Trigs/5..
.The Friedwald Equation has proven its validity in a trial,of more than 30,000.measurements The Friedewald equation has been criticised for being inaccurate for very high trigs..But the reality is a these inaccuracies can be avoided by a simple correction of the Trigs/5 factor..
The importance of the Friedewald equation was well known before and during the MORI and KURA trials period. The simple arithmetic of this equation makes it perfectly obvious that if the TC and HDC remain constant then any lowering of the trigs must result in a higher level of LDL..And that would what would have been obvious to both Mori and Kura. So arguing a POSA would predict EPA would lower trigs and not raise LDL is factully incorrect..A POSA would think it obvious that if EPA lowers trigs it must also raise LDL..
And actually in addition to the Friedewald equation..The molecular activity which leads to the conversion of Trigs into LDL-C was understood..The Lipoprotein that transports trigs in the blood stream is VLDL..(very low density lipoprotein) and this protein is principally APO-b..Which is a protein which also transports LDL-C...
VLDL (being made of APO-b transports both trigs and cholesterol) Normally trigs are the biggest fraction..but if trigs are lowered by more than 50% in the VLDL protein packet..Then the VLDL is converted to LDL-C..So definitely a POSA at the time of Mori and Kura would have considered it obvious that trig lowering by any means, including EPA, would have to increase the LDL-C levels..And not what Du thinks..
To this day it remains a mystery of sorts as to why pure EPA alone can lower trigs and not increase harmful cholesterol..It is still not obvious.
My hypothesis is that this special effect of EPA is the result of EPA's special ability to lower Systemic Inflammation (SI). What is understood today is that trig levels reflect not so much dietary intake or liver production...But are regulated in a similar fashion to way blood sugar levels are...And that is by controlling the rate of removal. We are more familiar with the effects of insulin on controlling blood sugar..Insulin activity increases the removal of sugars (which are fuels like trigs) from the blood and stores them in the adipose tissue and we should not be surprised if trig use similar methods...The key here is that Systemic Inflammation (SI) elevation causes Insulin Resistance (IR) and IR weakens the ability of insulin to lower blood sugar and store it in the fat tissue. Triglyceries have their own brand of Insulin which is called Fatty Acid Synthase (FAS)..and its potency is like Insulin is diminished by high SI...
A plausable reason why EPA alone might be able to lower trigs and not raise LDL-C i due to the fact that EPA alone effects SI levels..This is not controversial..It is well known to scientists who study SI,,just not well known to cardiologists an lipidologists..EPA's effect might operate to remove trigs by FAS while other agents,,Fibrates, niacin, or DHA Which lacks the correct 3 dimmensional structure to interact with the eicosanoid cell membrane receptors that are the major controllers..of systemic Inflammation..EPA...By lowering SI could lower trigs the physiological way by increasing FAS activity and that might not increase LDL as much as the non physiological removals by other drugs..
If we, including epidemiologists, cardiologists and Diabetes specialists..recognized the similarities between trig control and diabetes..Then things might be understood a little better,,We should be thinking Trigabetes.
I do not envy Judge Du having to consider all these complicated issues in lipid and inflammatory and can understand why she came to the wrong conclusion..There is no way in 2000 or even ten years ago a POSA would have reached the conclusion that DU reached...
It would be like me that has a background in Chemical Engineering and clinical medicine could not possibly understand the nuances in a comple patent issue..
":>) JL
Irish...
To the point..nice post...FDA generic approval is SOP..Generics only need prove the API levels over a period of hours are the same as the Brand...That is what bio equivalent means in the FDA....
FDA is not selling us down the drain or favoring Hickma..They are doing their job..If the decision in the AC is for Amarin then Hickma will merely have shown bio equivalence...
I like our chances in the appeal as Vascepa effects can hardly be obvious if the FDA label states the benefits of Vascepa in very high trigs in treating Pancreatitis and/or CVD events have not been determined..And this is 20 years after Mori. The FDA clearly does not think Vascepa's actions are obvious..
';>) JL
HK....
I would not bet all my money on Vascepa pulling someone out cytokine storm..This is more like endotoxic shock...Vascepa works on controlling resting SI levels...This is more of a homeostatic effect..The issues in the Covid -19 are triggered by the vectors or their components and the problem is they get in the circulation or the lymphatics and they act like a poison and hit all the cells in a certain system or sometime every cell.
It is more likely that someone who is on V or who is put on V very early could offer some benefits.(including great benefits) but it is hard to make a prediction base on what we know clinically about V..I am all for the company to test the drug..But I think they are wise not to suggest the drug will stop Toxic Shock as seen in COVID-19..
Better to keep quiet and not raise unrealistic expectations..Then if it does work then it should give the stock a real boost..
":>) JL
HinduK...
Nice post...What is the case with Du is she "cherry picks" her articles to arrive at the results she wants..Judges are supposed to be impartial and the evidence is clear and overwhelming she is not..This is particularly odius in a bench trial..where the judge is the judge and jury...
She is no judge...She is a liar and a cheat. A disgrace.
":>) JL
TTE...
Quote..Where is inflammation expert JL when we need him?...
Recovering from vascular surgery...
Cytokine storm occurs when things are wildly out of control..Classicaly occurring in systemic infections..Toxins are frequently involved more likely in conditions like gram negative septicemia...
I would comment more.. but the problem is much different than EPA/AA imbalances which lead to slow moldering chronic increased SI..Its like trying to compare a summer heatwave to a forest fire..
I have refrained from commenting on using Vascepa in treating COVID-19 cases because anything I say would just be speculation..It is possible it might help in COVID pneumonias...At present I am more interested in the up coming Appeal.
":>) JL
G...
Quote:
Defendants did not prove by clear and convincing evidence that the POSA would have been motivated to use substantially pure EPA as a treatment for severe hypertriglyceridemia, or that such a person would have reasonably expected to avoid a substantial increase in LDL-C using EPA in those patients. The prior art taught that every drug approved for lowering TGs in the severely hypertriglyceridemic — whether niacin, fibrates, or omega-3-fatty acids — raised LDL-C dramatically in that population, even though they did not have that effect when administered to patients with lower TG levels. The POSA attributed this increase in LDL-C to the way TG-lowering drugs were understood to work in the severely hypertriglyceridemic—enhancing clearance of the superabundance of VLDL particles to LDL. The POSA expected EPA to work the same way.
I thought you never read any of my posts...Guess the science is still alive and not dead after all..
More to the point is the FDA label for the Marine indication.
-INDICATIONS AND USAGE-----------------------------
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an
adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with severe
hypertriglyceridemia has not been determined. (1)
•The effect of VASCEPA on cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been determined. (1)
The fact this label is still current and has not changed since the FDA approval in 2012..does not support the notion that a POSA would be motivated to treat severe hypertriglyceridemia with EPA. The FDA states very clearly. The effect of Vascepa on the risk for pancreatitis or on CVD mortality or morbidity Has not been determined..This is still the case today.
A final consideration is that DHA actually is a more potent trig lowering drug than EPA (VASCEPA)..Would more likely motivate POSAs to use drugs like Lovaza
":>) JL
George...
Thanks for the reply...It's 6:30 AM and it will take some time to digest your reply...For one thing...You will not be able to exercise the puts after the event and realize any premium based on volatility because the drop is essentially instantaneous..Hedging with puts in the DU decision made a lot of sense because the pps drop was so large and so unexpected..it was a very asymmetrical bet...
At these lower prices its not the same and I favor not buying puts..but just sell some shares and buy calls..(they will be cheap)...The PPS drop if the AC decides for generics will likely not be very much as so many people believe that is a good possibility...I also believe the PPS will recover and come back to current levels because if the AC affirms Du we are in the same place we find ourselves currently..
My strat is to sell AMRN shares..Buy my number two stock..buy $10 Amarin calls..(the stock will go through the roof if the AC affirms Amarin)..don't buy puts...buy AMRN shares in the $4 range if the AC affirms the generics..
":>) JL
zip...
I never realised how concerned everyone was with my health...Quite a surprise...I'm doing fine..No stents. They just used a roto-rooter to clean out the pipes..No golf for a week...Abbott has a new device for sealing off the incision in the femoral artery which is pretty neat and gets rid of one form of risk...
Back to golf in a week...
Reading up on the subject of patent obviousness..Talk about stupid..Graham which frames the obvious topic was about a new type of plow..designed to avoid stones..And this is what they are using to wreck Amarin...I guess no one involved with the AC trial understands the important issue here is not obviousness. It is Property...
Unlike the plow industry..The rules in the drug industry are determined by FDA...FDA makes all the calls and determines all issues including obviousness...Since the Marine label still specifies that whether Vascepa is effective for treating very high trigs remains to be determined..Then where can "obvious" come in..
The important point is that it was Amarin who Sheparded through the FDA's long and expensive marketing process..Amarin has earned the right to market this drug..The generics are only entitled to market the drug under the Hatch-Waxman legislation or if the Generics can invalidate Amarin' patents...And they have not met the standard in doing so..The standard being the generics must clear and convincing evidence Amarin's patents are invalid...And that does not mean Amarin must prove the patents are valid...In this case the FDA and the PTO decided Amarin's patents were valid.. Only Judge Du...decided they were not valid...An opinion arrived at by factul errors...If the court can see the evil in this situation then woe to all of us and we need to move to Russia...
":>) JL
George...
Please understand..I appreciate the fact the Courts may decide in the generics favor no question about it..I also understand hedging..
Where we part company is in terms of strategy..I do not think buying puts in this situation is going to buy you much security...As a major factor in the price of the puts is volatility and you are not going to be able to cash in because by the time you exercise your puts..The volatility is going to be gone..and so is your hedge...I did agree with your previous hedge (at a higher strike and different thoughts about the courts decision..)
You describe the cost of the hedge as "a drop in the bucket" and I do not agree with you...Please understand I took off the rose colored glasses after Du's decision...My idea about the up coming binary event is that the price will fall if the generics win..but most of the price drop will recover when people realise we are in the same boat as we were before the AC decision..And we still have plenty of pastures to farm in Europe,,and elsewhere...So why blow your money on expensive puts....
":>) JL
Obviousness, patentability and Amarin...
The 1952 Patentability Act...The Patent Act of 1952 added 35 U.S.C. § 103,[2] which effectively codified nonobviousness as a requirement to show that an idea is suitable for patent protection. The section essentially requires a comparison of the subject matter sought to be patented and the prior art, to determine whether or not the subject matter of the patent as a whole would have been obvious, at the time of the invention, to a person having ordinary skill in the art. Clark held that the Congress, in passing the Act, intended to codify and clarify the common law surrounding the Patent Act by making explicit the requirement of nonobviousness.
Although patentability is a matter of law, the Court held that §103 required a determination of the following questions of fact to resolve the issue of obviousness:
the scope and content of the prior art;
the differences between the claimed invention and the prior art; and
the level of ordinary skill in the art.
In addition, the Court mentioned “secondary considerations” which could serve as evidence of nonobviousness. They include:
commercial success;
long felt but unsolved needs; and
failure of others.
However, the Court also recognized that these questions would likely need to be answered on a case-by-case basis, first by the United States Patent and Trademark Office (USPTO), then by the courts.
The difficulty of applying Graham to Amarin is there is an apples to oranges aspect..Graham was about a plow design and Amarin is about a complex drug interaction's actions on physiology..The lawyers might be qualified to discuss plow design but that does not mean they are qualified to discuss pathophysiology..
Graham criteria would appear to support Amarin.
Within bounds
'1) Vascepa is a commercial success (at least enough to fight over)
2) Vascepa addresses CVD event risk, a long felt but unsolved need which other drugs have failed to treat..
Then plainiff's argument and Judge Du's conclusion the Mori and Kura provide proof of prior art is ridiculous..To err might be human, but to base a legal opinion on a factual error can not possibly be the law.
Finally..The DC failed to include the role of the FDA in determining fact...Prior to the long and very expensive REDUCE-IT trial FDA specifically...approved no drugs for the Marine indication..The FDA
labeling specifically stated on the Vascepa label that Vascepa's ability to treat very high trigs is yet to be determined..In fact at that time there was no prior art accepted by the FDA...So in fact neither Mori or Kura were recognized by FDA as prior art..
":>) JL
It is still early in the morning here in Orlando..and I am scheduled for a "procedure"...this AM at 8:30...I have a minor blockage of an artery coming off the Right Popliteal Artery which supplys the gastroc and the anterior tibial muscle...They will perform a a catheter angioplasty via the right femoral artery..It is an outpatient procedure and I will be back home in the afternoon...
It has effected my thinking..Reading Georges comments made a lot of sense..regarding hedging..but hedging when the Amarin PPS is in the 7$-$8 dollar range is not the same as hedging the stock when it was in the high teens as it was in the Du trial..This goes to the issue of whether or not we are looking at a an asymmetrical bet..The Du DC issue was exactly the kind of binary event that hedging was indicated..Nobody in their right mind thought Du would pull off the stunt she did...So if she ruled for Amarin most likely there would have been not much of a price increase as a positive decision was "baked in" to the PPS...On the other hand a bet she would strike down Amarin was essentially disregarded..AND if you bet she would (hedge) as momma did..Then you were going to get paid off..(ie an asymmetrical bet)...At seven dollars..and the Du decision in the rear view mirror there is no one in his right mind that is not afraid the AC might sanctify the Du decision...So by similar reasoning a loss in AC is likely baked in to the PPS and you might not get paid off for you puts..
The asymmetrical bet in this situation. Is not to hedge..because if the AC decides for Amarin then the PPS is going right back up to the high teens..
These are the times that try men's souls...Here is more food for thought about this latest binary event..Binary events always increase volatility and volatility is a very significant factor in determining how much these puts are going to cost you.and how much you are going to be able to sell them for...One of the most important axioms in options.is you should sell volatility..Once the binary event occurs the volatility drops like a lead weight. This is called a volatility skew..So once the event result is known your options will fall in value before you can sell them..Costing momma more of her money...
The message here is You and I should have hedged the Du trial..but hedging the appeals trial probably the best you can Du (do) is sell covered calls..but you you could lose your position if the AC affirms Amarin..
What to do about Du...The stock market is never easy..You are always one trade away from humility..We all make mistakes...
Facts are the asymmetrical bet this time around is to go long..any PPS drop from a negative AC verdict is not going to change our situation very much...The generics are winning and will continue to be winning..That is what the market is expecting..A win is going to be like the R-I trial and will shoot the PPS up. I am planning on holding my shares and not buying puts..If the decision goes against us I expect a price decline..But I believe we will return to these current levels and eventually go higher. Amarin has a lot of turf outside the USA and that has gone discounted,,
The puts are not likely to pay off to any extent..This will be a classic "volatility skew"..Sometimes doing nothing is what you should do..
":>) JL
George...Thanks for the sage advice..I have not done a lot of hedging and been very lucky..but the Du decision was a painful lesson.. don't need to go through that again....
I guess the question is..When will the verdict come? Maybe the Amarin lawyers on the board will provide the decision date...
":>) JL
zip..not only do I agree with you...but I would even go further and say that calling Vascepa "Fish oil" might resonate with some of the appellate judges.because regardless the way most of us stand up and salute the Vascepa flag...Vascepa is a component of fish oil. Criticizing Du for calling a spade a spade might strike some as petty and might back fire.
These judges are not Amarin investors and do not post on this board. Du made many errors in her handling of the DC trial and those are what we need our lawyers to concentrate on not some side comment Du made in an interview that offends our tender ears...
":>) JL
zip...
I agree..We have the best representation money can buy..And without a doubt the judge was not impartial..But framed her opinions toward benefiting the defendants..even to the point of shifting the burden of proof regarding obviousness from the the defendant to the plaintiff...Which is counter to procedure.
We have a very strong case here on merit and a superstar lawyer..It would seem the only thing that can derail us is judges that are not impartial and favor the defendants..We certainly do not want to drum up sympathy for Judge Du..Let her words and actions in the DC trial frame her and not the fact she is a poor little refugee..a victim of hard times..Trying to do her best in a cruel world..
":>) JL
lizzy...
Can you post the article you are talking about..
TIA..":>) JL
marjac...
Can you post the article (from izzy) so we can read it..
TIA...":>) JL
marjac...
To who and where do we send these 'letters???
":>) JL
Obvious...
The thesaurus lists 50 synonyms for the word "obvious"..Introducing this evidence into the trial suggests the term is too vague and uncertain to be the basis of a legal argument..
"Obvious" goes to the notion of concepts...and in the population there exists a wide range of abilities to comprehend concepts..Albert Einstein was able to change the entire conceptualization of time and space by making observations on everyday events..Events that almost every one on the planet
could observe..But what was obvious to Einstein was obvious to no one else..Perhaps Du is a legal Einstein..but I doubt it..
Evidence does not support Du's opinion regarding obviousness..Obviousness means (among other things) clear and easily understood..Well the FDA did not see the obviousness..In fact the FDA, by broadening their search concluded on the basis of three other trials (ACCORD, THRIVE and AIM-HIGH)that there was no evidence to support the notion that EPA's ability to lower trigs and not raise LDL-C would result in meaningful therapeutic benefits..And as a consequence of this thinking went so far as renege on an SPA based on this scientific evidence (ie..the three trials showed no benefits)...And insisted Amarin run the lengthy and expensive R-I trial.
This is the real Amarin story and not Du's Fairy tale..
":>) JL
Meowza....
For God's sake ...throw a stick and maybe he will go away...
":>) JL
zip...
'
Good post....can you say... not impartial..can you say...agenda..
":>) JL
HK...
The problem with most of these reviews and opinions are they are made by cardiologists and lipidologists and as such they are trying to tell a story based on blood lipid levels when in reality the tale is mainly about what happens in the Eicosanoid system and the major effects are on Systemic Inflammation (SI)...The confusion results from the fact SI is the real puppet master and the lipids are just the puppets...SI pulls the strings..but lipidologists and cardiologists...are surprisingly unaware of this fact..
For example take Type 2 diabetes (T2DM)...The root problem in T2DM is elevated SI..Something medical scientists are very aware of, but clinicians for the most part do not understand..In T2DM elevated SI causes Insulin Resistance (IR) IR is a condition where the insulin becomes less effective at lowering Blood sugar..The end result is the T2DM patient requires higher levels of insulin to control his blood sugar levels..This produces a cascade effect because insulin not only lowers blood sugar..but it also elevates SI..Creating a viscous cycle..More Insulin means higher SI (Systemic Inflammation) levels and that means increase Insulin resistance..
The fact this goes unappreciated was brought out dramatically in the ACCORD clinical trial...One arm of ACCORD attempted to show carefully controlled blood sugar levels (A1Cs) under a certain level would lead to fewer CVD events...This did not happen and to the diabetic community it is still a mystery..Death rates were significantly higher in the control arm (the low A1Cs)...The reason was simple enough if you undertand the the pathophysiology. The culprit here was not the blood sugar it was the insulin..To get the lower blood sugar levels (A1Cs) Patients got more insulin and this increased SI and it was the elevated SI levels that was causing the increased CVD event risk...
The mot important effects of EPA are not related to changes it makes in blood lipids..That is just stupidity..The main reason EPA cuts CVD event risk down is not because if stabilizes the cell membranes (though it does). The major effect of EPA is on the Eicosanoid membrane receptors chiefly the COX and LOX receptors..For an active moiety to interact with these receptors it must have the correct three dimensional structure to fit into the receptors the way the correct key fits into a lock..DHA does not have the correct structure...EPA's effects on blood lipids are mainly effected via the eicosanoid systems effects on SI...
Sorry to say that even Dr. Bhatt who has been a wonderful spokesman for Amarin and Vascepa..does not seem to be comfortable with the SI effects of RPA and tht is a shame...
The legal system tries to simplify the Action of EPA and does a worse job than even medicine does..To argue ten years ago the effects of EPA were obvious is an opinion based on ignorance...I believe you could interview 100 cardiologist and less than 5 would be able lay out how EPA changes blood lipids...Finally in 2011--2012 era..I tried to explain on the ADA forum how EPA could lower CVD events in T2DM...And the upshot ws they accused me of being a shill for Amarin and had me permanently banned from posting on the ADA website...As far as I know..I am still banned...
Obvious..I don't think so...
":>) JL
bad breath
Why don't you try your hand at something you actually know anything about since law is clearly just not your game..
I know how about fighting Lyonels.
":>) JL