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ilovetech
Very much to the point...There are a limited number of explanations regarding this Judge Du's verdict.
1) She is a an affirmative action product who has been kicked up far past the level where she would considered competent...A poor little Vietnamese girl, from the camps, makes good..Now we get our payback
2)She has an agenda...Cheaper drugs for the downtrodden...She is well versed in the H-W laws that cover those issues in a equitable fashion. But In her opinion they do not go far enough. She sees herself as a defender of the lower classes.
3) "As suggested by an earlier post...Somebody got to her...(There is lot of money at stake here). Hopefully this is not the case. But it would not be the first time its happened.
She has been reversed in the past and she was sanctioned..There are clear and obvious factual errors on which she based her decision on...And yes they have the same effect as cutting off the wrong
leg....
For all you SJWs...Please skip BS. This is still America an I am still entitled to my opinions under the First Amendment freedom of speech...
":>) JL
Here's What you need to consider vs puts....
Check out the term ..Volatility Skew...
The idea is that one thing that effects the price of option, besides strike, price an X-date is volatility... That is not only volatility related to the VIX, but volatility related to the binary event. Both increase the price of options...And a situation that comes up frequently in these situations such as earnings or drug trial results, is the volatility prior to the event is very high leading into the event. But the volatility collapses once the event results are known..So this results in a "Volatility Skew" because the option's price drop dramatically once the event is announced..The upshot is your profits can drop to the point where they not worth anywhere near what you expect...The effect i mainly seen in puts which are out of the money...
The INSG situation is tricky here...First we re already down three points on the PPS and we are getting mixed vibes on the earnings..Half the analysts say we re going to beat the estimates and half say we are not going to beat the estimates...The best hedge here is probably serlling covered out of the money calls..The idea here is you are selling volatility and if you sell prior to the earnings call..The price of the calls you sold are going to drop and you can buy them back cheap..
":>) JL
Megc....
Thank you so much for posting this..Very convincing that Amarin not only has a reasonable expectation of getting this horrific decision by Judge Du reversed, but provides information Du left us enough to be somewht optimistic..Thank heaven for stupidity.... something Du has in excess..
":P>) JL
TI & G.
My daughter. Did weigh in On the Du verdict and the AC trial..Her comments were in some ways different than expressions made by other on the board..
First of all she did not agree that the Appellate Court (AC) would likely consider the DC judge's interpretation of the law as the sole or most important aspect of the appeal..Quite the opposite...She stated AC's are not likely to reverse DC opinions on the DC judges interpretations of the law..But rather, they, give them wide breadth...My daughters opinion was the errors of fact would weigh in to be much more important..Facts by their very definition are are not subject to opinion...
In fact my favorite expression is "The speed of light does not need the cloak of opinion."
Her second comment was that Amarin would not stand alone in this trial..The AC will receive advice from organizations such as the FDA (Du's opinion gores the FDA's ox)...The PTO...Representatives of BP and possibly even legislative bodies..Yes in most DC opinions they might get by with an error of fact..But not in this case...
My daughter might not be a thirty year veteran..But she graduated top of her class..She worked as a legal aid in a firm which actually encouraged her to go law school. (Normally law firms will fire aids if they think they are planning law school)..Post law school she was hired by a top law firm in Albany...And since the COVID-19 virus has hit New York very hard her firm was forced to work at home and they fired several of their associates...They have kept Bonnie and she has seen a continuous increase in her work load..She is a talented writer. Could make a living doing it...
I am not saying Amarin will prevail in the AC...But I don't think they are extreme underdogs either..The DC judge based her case on factual errors..failed to follow procedures expressly mandated by the AC (an offense one of out legal guys compared to "Assault with a deadly weapon" (at least to some of the AC judges). And finally did not not consider the secondary effects of her hasty decision. Considerations such as the AHA surprise at the R-I CVOT trial..Or the fact FDA reneged on the ANCHOR label because FDA no longer considered Trig lowering a a direct or even indirect marker for CVD event risk..
and According to the MARINE label.... Vascepa"s ability to reduce the clinical risk of Acute Pancreatitis or lower the Risk of CVD events remains unproven to this very day..So what can possibly be obvious.
Guess Judge Du...did not read the MARINE label.
":>) JL
flubber...
I agree...Most of the criticism revolves around the Du decision..This remains to be an open sore...and nobody can be certain that the AC will reverse her...
So we are once again waiting for a pivotal decision..I don't think there was really anything said in this sleep provoking session of poor communicators that everyone on the board has not considered..
The real issue here is taking the worst case scenario..Ie. the AC goes along with "ditzy Du"...How much of Amarin's value remains from selling Vascepa in Canada, Europe, China, and likely South America..These are all locales that the Generics do not touch..And that seems to me to be a wide swath...
I see the potential and it is enormous even though it may take a couple of more years..
I'm also in the camp that says the AC will reverse Du..(and yes I did think Amarin would prevail in the Reno trial)...I think we have a better chance this time because we don't have DU as the judge..
":>) JL
Going alone in Europe...
Probably not...Partnering in Europe makes a lot of sense...
A buyout by GILD...Not so much...Basically its all on hold until the Appeal decision..I like the fact that in most locales except the USA..There is no separate MARINE indication..
And yes JT is a worst public speaker than "Trigger the wonder horse". Good lord can't we pass around the hat until we get enough to send him to speaker school.
":>) JL
Tripple...
The European's do not have any alternatives...Regardless what they wish for..
On the other hand I am a great advocate of Amarin keeping the V profit margins very low...They will still make a lot of money.
":>) JL
From the Amarin release...
Quote: "Furthermore, the label being sought for VASCEPA in many of these geographies are not for the triglyceride reduction indication at issue in this patient litigation in the United States."
This is a big deal...They (the generics) don't have the MARINE indication to shoehorn in..
":>) JL
Jas...
The GILD drug is a farce..Not SS; not lifesaving..The positive trend was patients went home earlier (had a shorter hospital stay)..If that was Vascepa our stock would have cratered in 2018...
Add to that is the fact these viruses are shape shifters and even vaccines and drugs which are effective today are frequently useless in a couple of months..The only therapeutics that ever work for these viruses is time..The population that survives them, becomes immune to them...At least until there is a new mutations..and there is a concept called transference which means the viruses change as they move from on victim to the next..And usually this means they lose some of their potency...In a strange way its like the virus understands if it kills off all its hosts..Then the virus will be killing itself because there will be no more hosts...
The transmission of this virus requires contact..So social distancing and hand washing are actually the most important ways to limit the spread..Prevention is key here and not therapeutics..
":>) JL
Triple88...
Not sure I follow you...Amarin will have exclusivity in Europe..Regardless how the USA generic case pans out..The big 5 has no control over how Amarin prices V in Europe. If they don't think the drug is worth the money..Then don't take the drug...(there is no alternative)...Most likely Amarin is not going to gouge the Europeans..and the Drug price will be in line with the price in the USA...Amarin will make a lot of money off Europe because this is a volume play and not a price play...
":>) JL
INSG...
Needs a pullback..Stocks need pullbacks from time to time to remain healthy..This was one of Livermore's main points... A pull back of three to four points from the high would be healthy then we go up from there..
":>) JL
Robert...
Welcome to the board...Trig levels reflect SI levels...SI levels are determined principally by EPA/AA levels..Most likely in your wife's situation her AA/EPA level is too high...This could be related to a diet too high in Arachidonic Acid (AA)...You can get this checked at Quest Diagnostic which will do an AA/EPA ratio..
A diet high corn fed animal meat might..Walnuts are also very high in AA...
Chronic inflammatory disease could also account for increased SI levels..
Flax seed oil is touted for its N-3 effects but unfortunately it actually raises AA levels...
Good luck...
":>) JL
Bill B
Quote: or example, "TRL in particular might be helpful in explaining the biologic effects of icosapent ethyl (Vascepa; Amarin) in reducing triglycerides, Pradhan explained. “In terms of unlocking the pathways that are involved, I think they can be very useful.”
The enigma here (why trig lowering doesn't always lower CVD event risk) is actually known to those with skill in the art..The issue is really that elevated trigs are almost always caused by elevated Systemic Inflammation (SI) and not by consuming too many trigs. Blood trig levels are not to a great degree related to excess intake..Elevated trigs are almost always caused by an inability to remove trigs from the bloodstream..The most important equation in Chemical Engineering is "Input minus output equals accumulation"..
.Everyone understands the problem in diabetes is lack of insulin or insulin activity results in elevated blood sugar.. Not because all diabetics have a sweet tooth. Insulin resistance (IR) is a condition seen in T2DMs (type 2 diabetics) IR is a condition where the insulin is not very effective at lowering blood sugar...IR is a direct result of evevated SI...
The same rules hold for elevated trigs ( I like to call this Trigabetes)...Fix the SI in T2DM and you fix the blood sugar..Fix the SI and you fix the trig levels...Dtrugs which lower trigs without lowering SI are not going to cut CVD event risk. That was the secret sauce that caused the R-I trial to be so successful..High trigs are a marker for high SI in most clinical situations...Its not the trigs that are going kill you..Its the high SI levels..
":>)JL
zip...
"I'm sure your daughter would agree that it is important for an appeals attorney to take into account the judge's interests in planning which arguments to spend more time on.."
The crime scene is young woman...a nylon stocking is wrapped around her neck. examination of the conjunctiva shows petechial hemorrhages..The medical examiner concludes death was the result of strangulation. The victim's undergarments are torn the vaginal introitus is bruised and torn. Seman is extracted from the vagina..There are four suspects Suspects B,C, and D all have a history of attacking and raping women. there is a 8 point DNA match for suspect A...the judge declares that Suspect C is the perpetrator based on the fact his DNA matches that found on the victim.. and not those of the others.
How many here think that would be grounds for a successful appeal? How many don't..
":>) JL
zip sorry for the delay...
zip...She did not make a comment about the "cropped table..She was not making line item corrections...but rather her opinion on how the AC would regard Du's over all performance....
I included the opinion that factual errors would be more influential in reversing the Judge than her interpretation of the leg decisions issues etc...And I do understand that most of the opinions we've heard from various posters is the legal issues will be more important..
If I did not believe my daughter's opinion held water..I would not have posted it..But I did not post it simply because it was my daughter. To me it seems obviouus pure and simple facts are more clear and more defensible than complex legal issues issues that might be interpreted in more than one way..I would much prefer to argue a pound is heavier than an ounce. Than whether lipid changes result in a specific change in another lipid...We are all familiar with the Mineral Oil issue...Something that is debated by experts without any widespread conclusion. When my daughter tells me ACs are less likely to reverse a judge on the basis of legal interpretations..But there is no protection offered for judges that get their facts mixed up. Makes completely more sense than arguing complex verbiage trumps facts.
That's why we have fingerprints and DNA..And not a court debate.
":>) JL
zip....
Yes factual errors in medicine can cost us millions..Regardless of my daughter being just out of law school...Does not mean she is a dunce..There are issue which are clear and logical. And make sense to even people who have not gone to law school...
I purposely truncated my daughter's opinions to those who which not widely accepted...But were based on someone who is not an expert on the subject..but has common sense.. Aristotle did say "The law is reason void of passion"...
As a layman I take that definition to mean "reason" frames the law..and emotion (feelings) has no roll to play in legal decisions..
So what is more pure reason than the facts..And what is more unreasonable than than something that is not supported by the facts..I am not a lawyer, but I do understand from all the precedence that the law can be looked at from different angles which provide different points of view..But none the less, the law can never be correct if it is not supported by fact...And that is what my daughter confirmed..Appeal judges are more likely to give wide latitude to legal arguments...But not errors of fact...Four is always going to be bigger than three...And its not okay to say three is bigger than four...
":>) JL
jas...
TAAS stands for "Transportation as a Service"...Its the idea behind autonomous cars, trucks, and ships...Successful implementation would create a situation which was similar to the automobile replacing the horse and wagon..
Individuals would not own private cars..But rather rely on corps that own the vehicles and make them available at all hours..You would not be paying for a car unless you needed it..Right now if the car you own is not being used its utility is not being utilized..Under TAAS all autos would be Autonomous so you would contact your transportation company and tell them what time you wanted the car and where and when you plan to return...
Autonomous cars would not be subject to human error as over 95% of accidents are now..This would cut auto death and disabilities down and create huge cost benefits from safer cars..At present about 15-20% of major cities are occupied by parking lots which could be converted into more profitable use...
There are many other advantages of TAAS..but most require some discovery or innovation...Currently Self driven cars have been tested over millions of miles and are safer than human drivers..
TAAS will come and if you get it right you will be very rich..The question now is timing..
":>) JL
TET...
Yeah man..AMARIN WINS THE APPEAL....
":>) JL
jas...
I like the idea...but I am not sure if and when it plays out..The only stock it suggests is INSG...Which is already burning up the boards..I currently have a bigger position in INSG than AMRN...
INSG is way over due for a pullback..
I think Crypto is a scam...I do not go near it...TAAS makes sense its just seems a long way off.
:>) JL
MateoPaisa...
Where did I mention where my daughter went to law school...You seem to be more concerned with it than I am..Sorry if you went to some podunk school..not my fault..I am not obsessed with it, but your response tells me you are..
You have contributed nothing of value to the board and attacking me for providing honest information. Is not going to raise your status.
Please get over your pettiness.
":>)JL
My daughter's opinion on the appeal...
My daughter graduated last year from law school (top of her class)..Has passed the New York bar. And now works for for a large prestigious law firm in Albany...She came in as low man on the totem pole...and since the firm's billings have been down due to the C-19 V in New York she was very worried about her job...Since that time they have let several lawyers go..But my daughter is still working there (from home)..and the firm is increasing her work load as she is gifted writer.
As was noted on the board by Gabor..I did not push her for an opinion on the Du trial...Simply because she told me that patent law was nuanced and she did not feel she knew enough to give useful information...(not because my daughter and I are at odds).
I talked to her the other day and she was willing to offer opinions on the Amarin appeal..I will share these because they are different than some of the posts on this site..
1) The opinion by some on this board including some claiming knowledge of the law. Is that the appeal has a greater chance of being reversed based on points of law and not the factual errors made by the judge..(this never made sense to me) my daughter disagrees...She states with great certainty that appellate judges are much more likely not to reverse on the basis of points of law..the law is complex and leaves considerable leeway in its interpretation.Appellate courts give fairly wide leeway to district judges interpretation of the law.and do not like to nit pick,.On the other hand..Facts are facts and if the judge makes a factual error. On a crucial issue the Appellate is much more likely to reverse the judge..This bodes well for Amarin...
2) This appeal is not being heard in a vacuum. The court will be hearing from a wide variety of interested parties. Likely including the FDA and those interested in upholding the H-W legislation...BP should weigh in because if Du's opinion stands it places the FDA marketing process in jeopardy..And threatens the progress of medical science..This is an overwhelming secondary consideration..
3) Judges have a Section 7 requirement which covers conflict of interest.. Does Du have any conflicts that she has not disclosed...The company needs to look into it..
4) My daughter thinks Amarin has a very good chance of winning the appeal based on factual errors made by the judge...She also noted that judges opinions are not always written by the judge..but frequently by their clerks and even occasionally by students in law school in some cases..
My daughter told me...That when she first stated working for her firm they told her that she should begin by studying the judges..Their decisions, their biases, and their backgrounds..
":>) JL
North...
Quote: "I would pay: $9/3 month refill or $36 per year." How do you pull that off...Is that the judge lawyer price??/
":>) JL
HK....
Quote.."nevertheless the bigger question is her motivation"
I agree...I think there is a substantial possibility here that she does have a hidden agenda...Would not be the first time in recorded history..
I am always suspicious when errors and mistakes are always in the same direction. Mere stupidity or ignorance favors no side..But when all the mistakes favor one side...Then I think it makes sense to wonder if someone outside of the judge is pulling the strings...
I am particularly concerned with the fact the Judge copied the defendants arguments because that would be expected (perhaps even specified) if the fix was in..Face it..there is big money involved in this decision. This judge is a political Appointee..Lots of possibilities..
She is either the dumbest judge in the Federal line-up or something's going on here..
":>) JL
venus537....
Quote: "Publicly Amarin's plan is then to compete with the generics with their own generic Vascepa in the U.S. and have partnerships in Europe. That sounds like a nightmare within a nightmare."
Why so? The perfect is the enemy of the good. The market for Vascepa is going to be mind blowing...A fraction of Vascepa sales could be worth more than the whole pie of another drug...Amarin is going to have tied up a lot of the suppliers and very likely could have lower costs in producing the drug to the point where it is no longer profitable for the generics..I have always and still believe Vascepa will pretty much sell itself..Most people want to live longer..You can not look at the first couple of months of sales particularly when we are under quarantine.
Do we really need a partner in Europe...How bout using the Japanese model.Don't partner..Just open the dealerships employ the locals,,and have your people in charge of management..
The generics are not home yet..There is the very sticky subject of the fact Vascepa embodies a patented capsule which tends to retard the degradation of the EPA...Getting around those patents and complying with FDA requirements might lead to a couple of years or more delay or maybe the Generics will not get Judge Du in the next patent fight..
Keep your sunny side up...Pleasant dreams...
":>) JL
@TWI....
Thanks for digging up that article...Was a rat trial...But one thing about the inflammatory system is the basic design goes back 500 million years..So if it works in rats...Good chance it might work in humans...
":>) JL
KIWI..
Yes...The principle therapeutic effect of EPA is its ability to lower Systemic Inflammation by Increasing the number of Eicosanoid cell membrane receptors occupied by EPA vs those occupied by Arachidonic Acid and also the nuclear membrane PPAR receptors...
Acute Respiratory Distress Syndrome (ARDS) is an inflammatory condition driven by the driven by Immune response to overwhelming infection..This can be bacterial or viral..It is called septic shock in bacterial conditions where bacteria are in the circulation and are overwhelming the body's ability to combat the infection..The inflammation triggered by the infection then begins to attack the host..Whether EPA can turn the tide probably depends on when the drug is given...
Somewhere in my memory I remember there was a clinical paper where EPA was given for septic shock..I believe the paper suggested there was some benefit..It is certainly within the realm of possibility that Vascepa might offer some benefit in the COVID-19, but I don't know of any evidence on how much...Basically you need a drug that stops the virus from multiplying before it reaches the stage where it overwhelms the body..
JMO...":>) JL
gandalf50
Excellent post..Yes this has nothing to do with bigotry or racism...It's about the facts and about one individual and it has nothing to do with the fact she is black, white, red, yellow because no humans are actually those colors..This is about the facts regarding one individual Miranda Du. Judge and ESQ.,,,,
What I see in her decision is bias,,,For Christ sakes she copied and pasted the defendants argument onto her judgement..And made factual error as a result...This might be alright for you bleeding heart SJWs...But this is not right if her decision stands up on appeal she is going to hurt a lot of people and I don't mean just those on the board...And calling me a bigot is not going to save them...
When I was in Vietnm I was the only surgeon who did volunteer work at the Saigon Adventist hospital. I was the only surgeon who treated third party nationals just like I did American GIs...These included Chinese Nationalists, Vietnamese civilians including a seven year old Vietnamese girl who was run over by an Army Jeep..and had mid pancreatic injury with a ruptured spleen..(THe splenic artery goes along the pancreas. A Vietnamese police chief shot with 38 cal revolver. in the left upper quadrant,,whose pre op exam was not remarkable, but on opening him he had two holes in his transverse colon, three hole in the small bowel and a splenic perforation..
Actions speak louder than words..
I also treated the number one Italian war correspondent and his camera man (an Israeli) though I have forgotten their names (early Alzheimrs') They were brought into the hopital with frag wounds..They were with a ARVN platoon that over ran an NVA encampment and the ARVN's pulled the NVA flag up..The Italian knew it was time to duck and they hit the dirt..Nothing happened so they got up...Turned out there was a 90 second delay and they got injured..I was not on duty..but the other surgeon would not treat them...So they called me..Afterward the hospital realized they were celebs...The correspondent ended up giving me a Nikon Camera...and some of the personnel ask me if they would get them lenses..
I never based any decision on race or any other factor..At the end of the war I had an assistant who was 19 yo Afro American man who had gone through detox twice (not suppose to happen.) I took him under my ing nd he stayed clean..Towrd the end of the war there were equal number of blacks and whites and they tended to separate into racial groups..but there was very little animosity toward one another and no stupid nit picing or name calling like there is anymore from you sensitive types
":>) JL
I spent year in VietNam taking care of soldiers who unlike most of you who managed to get out of that tour of duty, had to serve and face death ..
I think that gives me the right to voice my opinions. Whether you agree with them or not..When I got back to the USA..I had a uniform on because we only had uniforms in Vietnam..People spit on us....So your comments are nothing...
":>) JL
fsulevine..
Like I effing care what you think of me.
":>) JL
raf...
Have you ever been in the military stationed over seas...
":>) JL
invest...
Yes...She is a poster child for affirmative action..Poor little Vietnamese girl from the refugee camps...probably jumped over thousands of of her white middle class sisters.
She was sanctioned...has been reverse about 8% of her trials..Was an Obama appointee...She was protege of Harry Reid..hmmm. Knows more about Vascepa than anyone at Amarin. Knows more about the patents than the USPTO...
Successfully defended and got a perp off who killed an FBI agent in the commission of a bank robbery...on technicalities..Got him released from an earlier conviction from the penitentiary...
":>) JL
Will Lar
"These two issues - no R&D and not owning API, will put a “low” cap on Amarin’s valuation. It feels like “manipulation”, but it’s not."
"A chacun son gout"
I consider REDUCE=IT as big time R&D...One of the most important trials in the history medicine...I think Amarin has been tying up API suppliers for the past four years..
Amarin may not be doing molecular biology or nucleotide manipulation..But it has done stellar R&D on treating the number one killer..
The Reno (Du) trial was a Black Swan event (an outlier)..I spent a year in Saigon and I know despite that liberals think that we are all god's children and everyone is fair, decent and honest..I learned in Saigon that was not the case..Vietnam was a country that for forty years existed in a perpetual state of war, The inevitable result was most everyone became cynical and concepts such as honesty had to take a back seat to practicality in a society where there was never enough for everybody..
I'm not saying I know Du verdict was framed by her earlier experiences...But understanding her background..I would not rule it out..I know I would not trust my fortunes to anyone with her background (through no fault of her own) as a refugee to sit on a bench where her verdicts could result in billions of dollars going one way or another..
And please no outcry from any liberal unless you were in Vietnam during the American occupation...We are all shaped by our own experiences as rocks are shaped by the river currents and the flow in Vietnam was much different than that of the USA for those of you home for the war..
":>) JL
TET...
Quote: "Yes, the future of biotech innovation is on trial here now.
This is the case that puts the magnifying glass on the notion of obviousness. It effectively allows generics to avail themselves of 20/20 hindsight to invalidate the very notion of innovation.
If this ruling stands, then new ideas will be required to come literally out of the blue -- no trail of reason or motivation permitted. If you can describe how you came up with the invention, then it's obvious. The mythical POSA is omniscient and clairvoyant."
TTE,,your three short paragraphs go the heart of the Vascepa vs the generics issue.. Progress of medicine is driven by questions. They never change...Only the answers change..Medical discovery does not occur in a vacuum.. Knowledge is driven by observation. But observation does not prove obviousness in medicine anymore than it does in physics. Einstein's great insight into the theory of Special Relativity was not driven by complex mathematics..Special Relativity relied on mundane observations that were available to everyone on the planet who was not blind..But only Einstein was able to draw conclusions that altered our views of space and time..of mass and energy..Du's opinion would be that Einstein's conclusions were obvious because everyone could make his observations..
Du's decision is madness and if the appellate court affirms it..They are no different than the authorities who damned Galileo..The law be damned.
Aristotle was an idiot..Why would anyone want to go through the FDA process if Du is confirmed..Mori and Kurabiashy...What eff were they..
":>) JL
Slim...
Looking pretty good..They seem to have account with most on the important
entities in the USA and several other countries...
":>) JL
South...
An amazing post...There are so many things wrong with Du's opinion..That even your post does not cover them all...The entire history of medicine is one big "obvious" treatment after another being counterfeited. At the time of King George III..The leading doctors of the time utilized phlebotomy (blood letting) for so many indications..because it seemed the obvious thing to (DU)..And today it is seldom used..We no longer treat amputation stumps with boiling oil..but at one time that was the obvious treatment..The Nobel Prize in medicine was awarded to Minot and Murphy for the treatment of Pernicious Anemia (PA) for their discovery that PA resulted from Folic Acid deficiency...it was obvious...Later Castle proved PA was not caused by Folic Acid deficiency..but by VitB-12 deficieny..
EPA's effects are complex and not simply the result of blood lipid changes as Du's opinion argues..Du left out the part where R-I reduced CVD event risk in patients at risk for CVD events. Every other drug which lowered Trigs had no measurable effect on lowering CVD event risk..And that is why the FDA reneged on the ANCHOR SPA and insisted on the R_I trial. And yes I understand the judges decision related only to the Marine indication for high trigs..But once the judge weighs in on the LDL issue in MARINE she makes a couple of huge mistakes..
First of all she "assumes" LDL-C levels are an accurate and reliable predictor of CVD event risk..That frames her argument..The truth is LDL-Cs record as a CVD event risk predictor is far from being air tight. Most first time MIs occur in individuals with LDL-C have LDL-C in the normal range..Also Judge Du apparently did not understand a very important result in Kurabiashi..Even though EPA did not increase the LDL-C level like DHA did...DHA actually increase the LDL-C particle size while EPA did not..Du did not apparently know that currently LDL-P (a measure of the number of LDL-C particles) is considered a more accurate risk predictor than LDL-C.. Current evidence is small numerous LDL Particles are more athrogenic than higher LDLs with larger but fewer particles..So armed with this information no risk factor could be determined from the reported data generated from Kurabiashi..
Du is a layman and like MD's discussing the law..She is in over her head when it comes to talking pathophysiology..
Even our learned cardiologists don't seem to fully grasp how Vascepa operates to decrease CVD event risk. It is because they are used to thinking in terms of lipids..But lipids are not the puppet master..they are just the puppets..Inflammation is the puppet master...High trigs are not the result of diets too high in trig..High trigs can only result from high SI...
Trigs act like blood sugar...only difference is they use different enzymes.If a non diabetic patient eats the same amount of sugar as as a diabetic low on insulin...His blood sugar does not go up as high as the diabetic's...The reason why is because the diabetic can not clear the sugar out of his blood..The rise in blood sugar is not do to increased intake (ie. eating too much sugar) it is due to an inability to remove the sugar from the blood...Increased SI results in insulin resistance. Which lowers insulins ability to clear sugar out of the blood stream and store it in the fat.
Although it is not widely known..but trigs are handled in a similar fashion using an insulin like enzyme that works on trig rather than sugar..High SI renders the trig enzyme Fatty Acid Synthase (FAS) less effective in clearing Trigs from the blood stream..Incidentally high SI also speeds up biochemical process including oxidation and platelet aggregation and other factors that cause blood vessel dammage..The fact is other drugs like fibrates, niacin or DHA lower trig levels but do not decrease CVD event risk...
Imaging Kurabiashi made all this obvious is ludicrous..I would estimate that less than 5% of physicians including cardiologist understand these facts..And that is why R-I results were so surprising...And this is 20 years after Kurabiashi...
":>) JL
Kiwi...
Quote: "JL. guess you have followed the recent update re the Malaria drug ...from the VA
Care to comment
Kiwi"
Not particularly...I don't know the details of the study...
I graduated Med School in 1967...A long time a go...I have learned that controversy is the hob goblin of medical research..We have 5 or more studies that say H-Chloroquine works and now we have one that says its worse than no treatment..Were the sickest patients put on chloroquine as a last ditch effort to save them...The Koreans found the drug worked very well and the results speak for themselves...
Care to comment..
":>) JL
Thanks tcanoy...
I have never been very impressed with Bhatt's focus on inflammation...He is an inteventionary cardiologist..But his take on Vascepa is fairly orthodox..And he seems to never have much to say about the inflammatory aspects of CVD or or how the EPA/AA ratio effects SI...Or anything to do with Inflammation...
We still haven't heard anything about the EPA and EPA/AA ratios in REDUCE-IT..I think Amarin might have been hurt by not understanding that EPAS's
On SI is very important and yet Bhatt just wants to talk trig lowering...
Guess you can get only so far when you employ a clinician. Don't get me wrong..Bhatt has been a fantastic spokesperson for Amarin and Vascepa..just wish he understood eicosanoids...There is plenty of excellent papers on the subject..
":>) JL
raf...
Quote:" patients are not just suffering from an inflammation of the lungs but also from an inflammation of all endothelial tissue in a wide range of organs
https://idw-online.de/de/news744978....
That is what you would expect if SI levels get high enough..Sounds like Amarin should do an R-I like CVOT on COVID-19 patients over 60...half get V half get M.Oil....Might be very interesting...Might also help our chances in the Appellate court if the results were good..Right now IMO the courts (and Amarin) have been paying far too little attention to the anti inflammatory properties of V which IMO are more important by far than the lipid issues..
":>) JL
Vascepa and the Covid-19 virus...
In an earlier post when the COVID-19 virus was first being identified as a threat. I suggested Vascepa might offer some therapeutic benefits...The reason being that in the most serious cases..The viral infection triggers a massive increase in systemic inflammation and Vascepa might mitigate that to a degree..Whether or not Vascepa is capable preventing the C-storm is not known..Whether Vascepa can prevent death in patients who develop C-storm is not known.
The possibility of that Vascepa has therapeutic benefit has to be weighed against the fact that Because Vascepa lowers SI that might actually enhance the pathogenicity of the virus. Pneumonia death rates are higher in Japan than in the USA..And Japan has significantly higher EPA/AA ratios in the population..
It might be difficult to design a study that would answer all questions..But once a diagnosis is made running a modified R-I trial on the C-19 patients could answer the question as whether or not the drug could lower mortality rate...In diagnosed patients..
":>) JL
TET....
Tasty...yes.."From the halls of Montezuma to the shores of Tripoli." It has to be Perkins Coie.
Back in the eighties I and my family were very close friends with a judge in the Federal Courts..Our families swapped dinners, my wife and I and the the judge and his wife went to comedy clubs and restaurants..And during that time I ran into a problem with the Plastic Surgery Society over advertising which was just beginning to beginning in the medical profession .
Things were different then virtually no doctors or even hospitals advertised..Professional societies (including legal societies) were thought to operate for the common good..and as such had a lot of power over individuals (they could throw you out on grounds you violated "ethics"). and it could have ramifications in the state medical boards. The plastic surgery society wanted me to rebut ideas they included in a certified letter..from the ethics committee...I knew this was a Kangaroo Court. knew doctors who had been sanctioned for minor offences..and it hurt them professionally...So I responded by telling them they were violating my first amendment rights..and that if they did anything that damaged my reputation..I would sue them in federal court..
I took this action after my friend the judge advised me the most important factor in federal court decisions is the lawyer. Judge R. recommended Bill Brown..The action I took (and I had prior lawyers one was Gov King's personal lawyer) and none of them gave me the advice that Bill Brown (RIP) did..He said the same situation was occurring in the legal profession as lawyers were beginning to advertise..Brown told me these were First Amendment issues and no one had ever lost a decision in Fed court when the opposition was strangling the First Amendment..
I sent an eleventh hour FAX to the ASPRS ethics committee telling them they would have to hold their meeting without me..and if they did anything that harmed me..I would be filing in Fed Court...Three weeks later I got a reply from the ethics committee stating they had insufficient evidence to proceed..and were tabling the issue..That was more than forty years ago...and I have not heard from them....
Lesson..The right lawyer is the key to winning in the Federal System...
Perkins Coie is the right lawyer...
The 7% win rate in reversals includes the cases that were not accepted for review..The Du opinion will be accepted and the reversal rate is in the 50/50 range...
":>) JL