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N sleven
Quote: "And apply for a patent based on the new information?"
We don't need EVAPORTE....
REDUCE IT is arguably one of the most important clinical trials ever run..
And we have tons of patents based on that trial and none of them were invalidated by the Du or the Appeal..
":>) JL
johnking...
Singer...what a crock of bullshit. If that guy is the best at appeals then woe to this country..
He sputtered and stammered...and in general sounded like JT trying present without a script..The argument "Bled into"...WTF did that mean..Why didn't he bring up the fact that virtually everyone in clinical medicine thougt V would not work simply because it was just fish oil..Why didn't he bring up the three clinical trials the FDA brought up in which they (the FDA) did not grant a SPA because they thought these trials showed that trig lowering would more likely increase the risk of CVD..Why didn't he ask how the patent office had it all wrong even though the patents were reviewed and were deemed non obvious...
":>) JL
9/2/2020....
Remember this date...For surely this will mark the end of the biotech era....
Who in his right mind is going have the investors, the patience and the time to invest all that time and money to go through through the expensive FDA marketing process..When some moron politically motivated district judge can give all this away to the generics...And regardless of how vapid and faulty her decision is it will be endorsed by some stupid judges who know nothing about medicine can ignore all her mistakes and give all the hard work away to generics who do nothing to forward medical science...
I compare this tragedy to the burning of the great library in Alexandria.
I weep for the future of medical science in the USA...
":>) JL
BaaBaa...
Quote..."Judge Dyk -which does just that)-conclusion he hadn't read the pleadings or studied the case that hard; and then 25 minutes or so of semi-engaged "analysis" of something with thousands of lives and billions of $$ at stake....."
Not really...The decisions of the ninth and the Appeals Court are limited to only the super high trigs indication...And that is not only a trivial indication in terms of lives in the balance (or Vascepa capsules) and Du..bless her heart, did warn the Generics (may they be transported to the the seventh ring)...that if they marketed generic VASCEPA for the CVD event risk indication would be inducing physicians to infringe on Amarin's patents..defined as indirect inducement.( a fact the generics did not like, and might welcome another shot at Du to convince her to change her opinion on that score). So maybe we don't want a "remand"...and maybe we should look on the sunny side and accept our minor setback..The unfortunate generics are not even going to get an unencumbered path to selling generic V for high trigs,,as Generic Lovaza has the same label and will be a lower priced alternative..Teva had the right idea when they settled for a couple of million dollars..
Time to move on...I am posting this message with the hope it will be contained on this board..and not be disseminated to the market as a whole..I would suggest waiting until the price sinks and stabilizes (at a lower level) and then perhaps you can increase your shares in anticipation of all the assets Amarin possesses..
The only trial you need to know is the REDUCE-IT trial...not these legal farces..A bunch of "farmers from the city"..all these lawyers and judges in their black robes...Mori was published in a non peer reviewed journal of nutrition....in Australia...Not even a medical journal..One of the articles in the same journal Mori was published was.."What is a Vegetable".
Give me a break...Is Lewis Carol not gone???
":>) JL
tke458....
I will give you my reasoning...I believe very strongly in asymmetrical bets and this stock could be the Grand daddy of them all...
First of all you need to think what the present situation and the future implications..I see from the many posts that some so called experts are blaming the PPS drop on the fact the generics has stolen Amarin's only drug..
And nothing could be more incorrect...As I mentioned this morning before the OA's..Amarin's reach is very much like the British Empire in the time of Victoria..This trial although centered in the nation's capital and is a superior court..The matter before it only pertains to the USA and only pertains to one indication for a drug that has many other indications and has plans to be sold in many locales other than the USA...
The trial was about the use of the drug for very high trigs..How high..over 500mg/dl a situation that effects mainly alcoholics and leads to acute pancreatitis. The court matter does open the flood gates for any other use of Amarin's drug and the same district judge who presided over the district 9 trial...opined that Generics would be infringing on Amarin's patents if they marketed for the all important CVD event risk indication...
The judge's ruling and the Appeal does not effect the European market, The Canadian market, the Middle East, South America..China etc..Do you think Amarin selling in all those markets that don't subscribe to the Democrat monkey business which is ripping this country apart..Don't you think Amarin would be worth 4$ a share and then some..Amarin has not lost its markets. Other locales are also going to be interested in a drug which can lower cardiovascular risk to a population at risk...
As long as the court can not prove that Vascepa does not work as advertised then Amarin will retain its intrinsic value..I bought shares at 90 cents when the world did not think the price was worth 4$..I don't see any reason to believe Amarin is worth less today..Think about the great REDUCE-IT trial..No other drug in the world has come anywhere near to what Vascepa showed in the R-I trial....
I want to wait until the stock goes down to 4$ or lower and really load up because none of these court trials come anywhere near establishing the value of Amarin that the R-I trial showed...
":>) JL
Amarin as a long term position....
It comes down to "Enterprise Value" and the asymmetry of the bet...Simply put...What is the company worth and how risky is holding the stock..Amarin is a drug company with one drug...The rules do not really apply to Vascepa because it is more of an essential ingredient than a treatment for a single indication...In evaluating the company it is important to remember Vascepa is marketed and sold in many locales..Such as the USA and Europe...and has to the potential to be sold in many other locales and Amarin is currently valued mainly on its value in the USA and for limited indications...And it is not even the case that generics will be able to sell the drug for the all important CVD event reduction indication...
The first point being that all this local litigation does not threaten the companies right to sell the drug for all known proven remedies. The litigation is far more germane to the generics..The case being they have temporarily won the right to sell purified EPA for the very high trig indication. And this is not even uncontested as Generic Lovaza has an identical FDA label and is cheaper than generic VASCEPA. by all accounts Europe does not have our convoluted FDA situation and we do not have much concern over Vascepa's priority in the European market..(And Europe is a bigger market than the USA)...The point is the generic issue is not an issue in Europe...As most of you understand..Vascepa is a lifelong drug..
There are other markets..China...The middle East, Australia., South America, Canada, Africa... The sum total which dwarf the USA...Vascepa has a world wide market that is too large for most imaginations. Big enough if we lose some locales we are not going to go broke..Think of Vascepa as the British Empire at the time of Victoria..Do you really think the dubious loss of one of V's indications means the end of the Empire? The Company selling in single digits..is a joke..
There is no downside here...just time for things to happen and that is where the company's management and we shareholders need to focus our attentions..The thing here is patience...and not panic...
":>) JL
invest....
Looks like 7 to 2 odds for Amarin...(considering only the judge issue) In "No Limit" this is an "All in" situation. Not a coin toss...Of course from the other side is "Gambler's Ruin" if you put in all your chips.. and get a bad beat...
IMO the real issue is how weak is the Du decision...And IMO it is weaker than a bridge made out of toothpicks. Du's decision is an equal opportunity case for procedural and factual errors.
She trashed the notion that defendants must meet the standard of proving the plaintiff's arguments are not substantial, "in a clear and overwhelming manner". And transferred the burden of proof to the plaintiffs.
She trashed the SCs....and backs up her thinking by statements that indicate she does not understand the factual evidence..and makes statements which were clearly errors. Errors can only be explained by a clear bias favoring the defendants or the judge lacks the knowledge or mental capacity to understand the facts..
Du has been "sanctioned" in the past..Her record is not spotless.
":>) JL
Study,,,,
No need to apologize...It is not very clear and slowing the progression might very well reduce the plaque in the active arm if the progression of plaque is slowed...So you might be right..
It's just that it is not very clear... In their earlier updates they did stress the fact that it was mainly that EPA slowed the progression of plaque..And I do not remember any mention that plaque was reduced..
I don't know any reason why an author would be emphasizing plaque progression and not plaque volume...
":>) JL
Study,,,,
No need to apologize...It is not very clear and slowing the progression might very well reduce the plaque in the active arm if the progression of plaque is slowed...So you might be right..
It's just that it is not very clear... In their earlier updates they did stress the fact that it was mainly that EPA slowed the progression of plaque..And I do not remember any mention that plaque was reduced..
I don't know any reason why an author would be emphasizing plaque progression and not plaque volume...
":>) JL
jf
I love the movie and the song...Lee Marvin got the Oscar for playing the drunk "Kid Shylene"....and the bad guy with the silver nose..
Young Jane Fonda....The sweest villian in the history of movies..
":>) JL
zip....
Yes Du also made legal errors...My understanding as a layman based on what the excellent lawyers on this board have stated is factual errors would be considered more important in deciding to let the judge have another try (a remand) because the subject matter might be over his or her heads...
Her novel approach to Graham. Would not improve her chance to do a re-do. The procedural error makes her come across as lazy and not diligent..
":>) JL
raf...
The graphs specify "progression" and not the amount of plaque...I know this is very confusing...If EPA "ate the plaque" don't you think the doctor running this study would have made it very clear. and would not have presented the results in this confusing manner..
Also slowing the progression of plaque accumulation is very likely a good thing..
":>) JL
johnking
Yes that is what I am saying...
:>")JL
raf....
Quote: What am I missing?
Check out the fine print under the bar grafts. The bar grafts are measuring the rate of progression...
":>) JL
raf....
My understanding is the fact Du made factual errors...Means there is very little chance the case will be remanded back to her..The law can be argued and interpreted. The facts...well you have to know and understand them.
":>) JL
sleven...
Evaporate does not show EPA reduces plaque. The study only purports that EPA slows the progression of plaque. There is no claim V will reduce plaque or stop plaque from forming....Also it is unclear (to me) exactly where the the locale of the plaque retardation is taking place..and this is important.
":>) JL
Kiwi...
The procedure went very smoothly..Swav to the Right Popliteal artery. I had a previous procedure A low pressure ballon on the same artery and the artery re-thrombosed the night after the procedure with no therapeutic improvement...
The cardiologist who did the first procedure..told me there was no reason to try Swav as the there was no distal run-off...A month later and I am able to walk three miles or as long as I want with no claudication...
":>) JL
slim....
Thanks... I do not see the upcomming presentation you mention on the the events and presentation page...Where are we suppose to register?
tia..":JL
Price action....
This is what you get when you "offer" "Convertible Notes"...A bunch of hedge funds shorting every move up because it is in their best interests..Shorting not only keeps the the interest they are drawing "Market Neutral" (no risk) but insures (in most case) you will get more shares when the notes are converted..
Why the management would have decided to go "convertible" rather than just do a secondary is beyond comprehension. Its not that they have an humongous float..It's one jump over being a liquidity hurdle...Jesus everybody complains about about secondaries..but the truth is a month or so and nobody even remembers them..and they don't lead to situations like this one..Doing a secondary in the $8 range is not like the stock is trading for a dollar. I try never to own shares in a company that does a convertible///
And now I remember why..
":>)JL
Trueheart...
Patience Grasshopper...Reactions are healthy..The chart on this puppy looks very good and if it was simply straight upward without the pullbacks This would be very scary..
I got in this stock three months ago..Because you can not have EVs without recharging stations..Honestly I thought this would be dead money for a year at least..Then I woke up a couple of days ago..and the stock was on a steroid rage...two days ago (or was it yesterday?) I doubled my position at 12.78..It is currently lower...but the action looks like it will not last too much longer..
I am a great believer in EVs..Even though I currently drive an Acura NSX 2019 (red) and it might be it might not be street legal in five years..I saw a Yellow one at the dealership..The most beautiful car I have ever seen .
I am a great believer in Taas (Transportation as a service) and believe it will have a bigger effect on the country than the internet did..It requires autonomous EVs. And they require recharging stations..
I do not claim to understand the current attention and price rise on BLNK..But it does not look like a bunch of amateurs..And I have been trading for over forty years...Whether this is the possibility of Tesla buying the company..Who knows...The market does not offer a "college education"...We will find out..So far the action looks good to me..
":>) JL
Retiredceo....
Yes..I have a cardiolgist...Dr. Kasi...who is upon all the latest changes in cardiology..He is the only doctor in the Orlando Fla..area who uses Shockwave...I had a procedure done last Friday on my Right leg..in the popliteal area...This was after another vascular surgeon tried a standard clean out procedure in the same area..The vessel remained open less than 12 hours...By the next morning I was right back where I started..no improvement..
ShockWave done last Friday...This morning I walked 2 miles with no claudication...no pain...
I have the coagulation gene..I am currently on Vascepa..Eliquis 5mg bid
(2 times a day).pediatric aspirin 81mg..and Cilostazol 100mg qd.(once a day...I had a very serious Pulmonary Embolus last year (called a "saddle back" embolus)...I was put on Eliquis...and over a period of a couple of months Eliquis ate the thrombosis..
Not practicing medicine or making recommendations. Just citing my own personal experiences it might be worth looking into Shockwave and Eliquis.
":>) JL
George....
He may not be credible to you..You still have not given us your credentials..I'm guessing ..you have no credentials. What makes you think the guy who was blowing smoke at the Yale doctor...Wasn't the guy who was full of it..I can tell you just making some arrogant remarks and impressing yourself by what you think is clever Reparte'..Doesn't mean you know what you are talking about...
":>) JL
Retiredceo....
Best drug for your friend is Eliquis..Better for a PE than VASCEPA ..wouldn't hurt to add VASCEPA..I Have the genetic blood clotting gene..
":>) JL
George..2020..
Quote..."Prof. Risch is a joke."
Risch is a Yale professor..and renowned Medical Scientist...AND What are your credentials...Or are you just easily impressed...
":>) JL
marjac...
Du has managed to turn this stock into a "Bow-Wow"..I hope the appeals judges understand that if Du's opinion is not reversed that no company in its right mind will ever select the Ninth District for a patent trial..No one is going to make that mistake in the future...
":>) JL
Thanks slim...
Seego is my number one position right now..I cant wait until they get into the autonomous vehicle market..The company and its management seem to have it "going on"..Tass (transportation as a service) is going to be big a deal in changing the way America and the rest of civilization does business..And INSG looks like it is going to be a major player..
I notice in one of the companies ads they listed most of their projects and the first mentioned was autonomous vehicles..
":>) JL
Kiwi....
Underwent a "Shock Wave" procedure on my right lower leg on Fri July 24...Discharged on Sat...Today Monday I was able to walk one and a half miles with no calf pain...I had a regular balloon balloon procedure last month and had absolutetly no benefit..
My vascular surgeon who does not do "Shock Wave"...told me after the procedure that there was no run off in my popliteal artery and nothing could be done..My cardiolgist did the "Shock Wave"..and put in a non drug alluding stent..Which will require I stay on Eliquis, and pedi aspirin. And Vascepa for seven months..
The cardiac trials for "Shock Wave" are about to be completed and the results are going to be good..."Shock Wave is safer than traditional balloon atherectomies.."Shock wave" liquefies calcium in the arteries.
This morning I could walk a mile and a half and experienced no calf pain which means the the circulation is back to normal...
":>) JL
Marjac....
Quote: "There is a strong likelihood that this whole fiasco could have, and should have been avoided simply through the prudent choice of venue."
Yes..Very sadly this was the lynch pin of the disastrous mistake..The ninth is a hot bed of liberal socialistic thinking..It is hard to imagine that Covington could have made such a error..This should have been litigated in Texas or some place where the judges still believe in the law..
":>) JL
rosey...
Quote: "Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days."
What the heck does that mean...So they came into the hospital with a "Mild to moderate case"...and their clinical status did not improve..Did it get worse or better in patients given other drugs or treatments..Was the death rate lower or higher in the HCQ patients...
How bout giving us a clue...
":>) JL
jas..and others...
John Barry's unbelievably great book.."The Great Influenza".. About the 1918 pandemic..It was running right along beside World War 1 and there were people in the USA that thought it was the result of German Biological warfare (It wasn't)...
Besides being very informative on viruses, contagions it goes on and on about the effects on the population as the plague moved from town to town and spread out..And the result was fear...The 1918 pandemic was several magnitudes more deadly than this current contagion..Fear often resulted from the experts and authorities trying to downplay the danger..And the medical authorities such as JAMA did not go along with the politicians and civilians..JAMA told it like it was..deadly beyond belief..Women would volunteer. Thinking they were noble and brave like Joan of Arc..They quickly dispensed with these fantasies in the hospital halls of death or homes where only the orphans remained. These Joans all quickly disappeared. These "brave" women just quit after half a day..And never returned..The grave diggers all quit. Afraid of the disease and the families were left to bury their dead..There were no more coffins and victims were buried in mass grave eventually dug by steam shovels...No more morticians..They all quit...
Useful information...In the influenza pandemic..The period of death and contagion in any area was in the neighborhood of six to eight weeks..After that "passage" the virus became less lethal and there were fewer cases because the survivors had some immunity and there were fewer numbers of people who were first encountering the virus..In most cases not enough hosts for the virus to infect or spread..And the contagion did not return.
If you want to stay ahead of the bull and know the real truth..Get the book from Amazon...
":>) JL
James...
I do believe the company should actively pursue the possibility Vascepa could cut the mortality rate of the C-19 virus down..I believe using Vascepa early would have the greatest effect..This would completely turn around the whole fate of the company. Even though Amarin actually already addresses a condition greater than the Virus..Right now the Virus commands the stage...If Vascepa can cut down Cytokine Storm..and lower the deaths..It will be on the front page of every paper and Americans will want to kill H&R for messing with Amarin...(They might even go after the judge.)
":>) JL
James...
I would say Vascepa makes more sense than most of the other wannabes. Raging SI brought on by the massive activation of the immune system offers EPA the possibility of lowering the inflammatory levels...Just how much and how effectively Vascepa would deal with Cytokine Storm is still undetermined, but we do not know that it doesn't work..And it is a better story than anything else so far.
We do know a great percentage of death from in Covid infection is not from the virus directly, but from the inflammatory system which is stirred up by the immune system...EPA interacts with all the cells except the red blood cells and acts to moderate inflammation..We know that is a good idea..We just don't know how effective EPA would be in this case..
":>) JL
jasbg....
Quote: "A new study demonstrated how a common, FDA-approved drug could halt lung damage caused by the coronavirus. Researchers at Israel's Hebrew University of Jerusalem and New York's Mount Sinai Medical Center said they slashed the severity of COVID-19 by reducing the ability of SARS-CoV-2, the virus that causes COVID-19, to reproduce in lung tissue.
According to The Jerusalem Post, the scientists said the cholesterol-lowering drug, fenofibrate, also known as Tricor, starved the virus from its fat sources until it almost disappeared within five days. The research was performed in lab studies both in New York and Israel and used different samples of lung tissue. The team hopes to replicate their results in animal studies since the drug has already been proven safe.
"By understanding how the SARS-CoV-2 controls our metabolism, we can wrestle back control from the virus and deprive it of the very resources it needs to survive," Hebrew University professor Ya'acov Nahmias said."
I just don't get this...A new study demonstrated how a common, FDA-approved drug could halt lung damage caused by the coronavirus. Researchers at Israel's Hebrew University of Jerusalem and New York's Mount Sinai Medical Center said they slashed the severity of COVID-19 by reducing the ability of SARS-CoV-2, the virus that causes COVID-19, to reproduce in lung tissue.
According to The Jerusalem Post, the scientists said the cholesterol-lowering drug, fenofibrate, also known as Tricor, starved the virus from its fat sources until it almost disappeared within five days. The research was performed in lab studies both in New York and Israel and used different samples of lung tissue. The team hopes to replicate their results in animal studies since the drug has already been proven safe.
"By understanding how the SARS-CoV-2 controls our metabolism, we can wrestle back control from the virus and deprive it of the very resources it needs to survive," Hebrew University professor Ya'acov Nahmias said.ir"
I don't get this..I'm pretty sure Viruses do not need fat...They don't eat and they don't excrete...They don't have sex..Virus life must suck..
Feno fibrate is readily available...guess everybody would be using it to cure COV-19 if it worked...Why haven't we heard about this..I'm tired about all these discussions about ventilators...
":>) JL
Marjac....
To the warrior who stands in battle goes the glory...During the height of the Vietnam conflict..In country we had a saying..If you were not here..
Then "STFU."
I have no problem believing judges could have a political slant in their decision making...I do not doubt that could be a very bad thing. Can anyone come up with better explanation for Du's opinion.
":>) JL
rosey...
This is all news to me. I can not say they are wrong..but their logic is not clear..They state Viruses can not replicate themselves..By that they mean viruses require RNA or is some cases DNA found in the host cell to create new viruses..And that viruses require fat...Well by the same token that viruses require cellular nucleic acids. Viruses do not require fuel or burn fuel..So I am not sure how fenofibrates fit into the pattern..
We know from the famous three trig studies that fenofibrates do lower trigs..but do not lower inflammation to any great degree..
So I have no opinion..I guess we will find out in due time..
":>) JL
raf....
Quote: 3) My favorite is seeing signs on restaurants that no mask = no entry.... while those restaurants have indoor seating areas, where people eat WITHOUT A MASK.
You raise a lot of important issues..Most people (excluding bank robbers) don't wear face masks by choice..Face masks are aggravating particularly in the summer in Fl. where the temp is 98* degrees and feels like 106..Breathing is more difficult due not only to the resistance of the mask material but also from the flapping of the mask during inspiration. and this leads naturally to people elevating portions of their mask to relieve the obstruction of air flow. This is done with the fingers..If you wear a mask in very warm and humid temperatures. After a period of time you will begin to notice saliva is forming at the corners of your mouth..A kind of mini drool..The temptation here is is to wipe the corners and this can lead to hand to mouth contamination..
IMHO..Masks are just another example of "Because I am the Mommy" reasoning..And now in Florida you can get 60 days jail time for going maskless..And that is with no real proof masks actually have any preventive value..
":>) JL
Abivertinib, shuts off two cellular signals that can cause inflammation. Unchecked inflammation, known as cytokine storms,
Hard to predict where this is going..Researchers stating they are targeting patients in the ICUs who are not on a ventilator...Cytokine Storm is the immune inflammatory systems out of control. Not on a ventilator... So not sure who they are treating here..Small scale study 40 patients....probably would work if every patient in the study was in dire straights..But this seems to be another Gilead study where we don't really have a meaty end point...This looks like plan to get some free publicity...
Hoping to hit the jackpot..My money would be on Vascepa..
":>) JL
HChloroquine....
Acts to limit C-19 virus from entering the cell interior via the ACE receptors...And yes it will not bring back someone from the dead (needs to be used early in the disease)...Will not block Cytokine Storm or irradicate secondary bacterial infections that don't use the ACE door...
I have not gone over the quoted trials that say it is not good for COV-19..
HCQ will not make a drug company huge profits like the GILEAD drug...but it might save more lives..We need to make sure our politicians and our media doctors are not putting their politics and money ahead of our welfare..
":>) JL
duke...
Surprisingly wearing a facemask does not seem to keep the hands out of the mouth..According to studies published..
I don't have any problem with wearing a face mask...I just think it does not add much in the way of prevention..
Also Florida has had some testing stations that have had close to 100 % positives..Unfortunately politics raises its ugly head..Too bad all our politicians are not fair and honest.
":>)JL
marjac....
Thanks for your time and skills in this legal matter...
":>) JL