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Ilove...
The problem is not the doctors..It's the drug plans..They are like purposeful idiots..They may seem stupid..but they somehow manage to maximize profits...
You have been posting long enough to have heard the rants of people on this board who had their scripts substituted for..If FDA label says both Vascepa and Lovaza lower trigs in the 500 mg/dl range and both of them have the same risks and benefits..Then the drug plan is going to give you the cheaper alternative..Unless you want to pay substantially more for the more expensive alternative..And believe me the strategy here is to deliberately punish individuals who want it their way...
It was not Amarin just doing a crappy job of lowering Vascepa prices..Thge rules were stacked against them...
":>) JL
GM..
Actually the rule in most cases is the cheapest alternative is awarded the Tier one and in most cases that is the generic..The problem the generics face in this situation is there is more than one generic and both have the same indication and usage. In such cases the drug plans will go with the cheapest alternative and that will be gen Lovaza as it has been. As Vascepa is much more expensive to produce..This situation actually has been going on for some time..Its just it will not be Amarin vs Lovaza it will be Teva {if they make gen Lovaza} against Reddi and Hikma..
Most of the Amarin MB here has complained about how Lovaza has dominated Vascepa..The reason is/was the situation was that the drug plans look at the indications and usage on the label and then they go with the cheapest alternative. And that is why there was so many of Amarin scripts which were being converted to Lovaza or Gen Lovaza scripts..Remember up until late December last year the only label Amarin had was the MARINE label..
The same thing will happen to the generics unless they can sell gen Vascepa cheaper than gen Lovaza..(not likely)..The generics are prohibited from advertising or promoting their drug..Vascepa for CVD event reduction..And they can not go to the drug plans and tell them their drug actually reduces CVD events and that is why we are selling it..That would infringe on Amarin's patents that are still valid..
":>) JL
It's somewhat complicated but understandable..We have winners and losers..
Winners are Teva and Amarin... Losers are Reddi and Hikma..
Teva made a good decision taking a settlement..They understood the generics would only be getting the Marine label (if anything) and not the R-I label.
So if Teva owns the rights to gen Lovaza and Lovaza had the same label indications as the Marine label..Then Teva would be able to sell gen Lovaza as a cheaper alternative to Marine Vascepa..Cheaper would mean Gen Lovaza would always dominate Marine Vascepa..So it would be Teva dominating Reddi and Hikma...Too funny..
Amarin would have the REDUCE-IT label for Vascepa for which there is no alternative. And only Amarin would have that market unless another patent trial could prove all of Vascepa's CVD patents are obvious and that will never happen since nobody predicted Vascepa would cut CVD risks including death and strokes in the twenties range..
The R-I indication is completely divorced from the Marine indication and the Reddi and Hikma are going to have a very difficult time trying to horn in on the R-I label..I'm predicting that both Reddi and Hikma will settle..
":>) JL
circuit..
Isn’t GL owned by Teva, another GV to V?
Might be the reason why Teva settled..
":>) JL
nmiall75...
You sound like you might be an understudy to MRC..
Quote: "The thought occurred to me, reading the learned comments in this forum, as to whether the Appeals Court could find that inferences not supported by Mori’s study were possibly nevertheless drawn at the time due to Mori. In turn might they say that a researcher could have believed as obvious that EPA would not increase LDL levels even while accepting they should not, based on a correct understanding of Mori, have done so?"
Wow..This is real big time gibberish even by this board's standards..You are arguing what?...That just because a researcher could make the same factual error Du did that Du was correct..The issue of burden of proof does not lie solely on Amarin...Du actually made a procedural error by shifting the burden of proof the PTO's patents were not obvious to the plaintiffs and not to the defendants having to prove by clear and overwhelming evidence that the patents were obvious..
Also..FYI...Everyone who was knowledgeable in the lipid field at the time of MORI was of the opinion that trig lowering would reflexively increase LDL-C levels..So your tax example is not applicable in this case..
":>) JL
ilove..
I think you are missing the point..What the generics want and what they are going to get is a very wide gap..Throwing terms like "sex appeal" does not improve the quality or validity of a post..
The reason Amarin has had such a problem competing with Lovaza has nothing to do with incompetence...It has everything to do with the fact that until late Dec 2019 Amarin only had the MARINE label to rely on..Fact was Lovaza has the same label and it is cheaper..And the drug plans..after considering all other facts are going for cheaper..and in many states it is the law..So as we use to say.."you can stand on your head and spit wooden nickels", but those are the facts..
Now the generics Reddi and Hickma (H&R) are going to have to deal with those same facts and they are not going to do anything about them either..H&R do not have the R-I label indication.. Without that the generics are going to find they have next to nothing..The minute they try to go after R-I..Amarin will slap them with a patent infringement suit..
":>)JL
sleven...
Vascepa is Tier 4 in most drug plans..Tier four is designation for a brand drug for which there exists a cheaper alternative...The cheaper alternative here is Lovaza..The drug plans have ignored the R-I results because the FDA label did not change until late December 2019 and this was after the Tier designations were determined...for 2020...
GV will never be be Tier 1 as long as Lovaza or GL is cheaper..Lovaza has the same label as GV For Indications and Usage...GV or GL neither have the R-I indication and beginning next year Vascepa prescribed for CVD risk reduction will not have any competitors..
":>) JL
My apologies to the board...Re several Typos in my earlier post which made a complicated subject more complicated..
The idea behind the post is that even if the Appeals court decides in favor of the generics..and invalidates Amarin's patents and allows the generics..(Hikma and Reddi) (H&R) to sell generic V in the USA; The generics may have won very little and Amarin might have lost very little..Posters might contemplate what that translates to in terms of Amarin's value..
What H&R have won is the right to sell generic V for the Marine (very high trig label) but what H&R have not won is the right to market generic V for the REDUCE-IT CVD event reduction label..Now just so you posters understand; I realize H&R probably have their sights set on the R-I indication which they believe they can capture via "Off labeling"..IMO that is not going to happen. H&R's scheme is going to run into some unanticipated road blocks..not from Amarin but from Lovaza (L) and generic lovaza (GL)
Lovaza (GL)..L and GL both have an FDA very high trig indication and usage label.. The L and GL FDA labels are identical to the H&R GV FDA labels..(word for word). So as far as the drug plans are concerned, these drugs are considered identical..H&R by the court rulings are unable to say.."Pick us because we come with CVD event risk reduction.. Because H&R have not won that right in court..And please understand the drug plans are not going cut H&R any slack..Any attempt on the part of H&R to sell for the R_I indication will be deemed an infringement on Amarin's patents.
How do we know the drug plans will not cut H&R any slack? Amarin knows from experience...Even this year, Brand Vascepa was listed as Tier 4 (most expensive) on most drug plans..And that is after the FDA label expansion to include the REDUCE-IT results..Reason...is, the label expansion by the FDA was delayed to late December 2019..This was after the the Tier designations were made for 2020...and most drug plans have blithely ignored the R_I results and will do so until the next Medicare enrollment periods in Nov of 2020..Why...because it saves the drug plans money..So as you read this, Amarin is still competing with Generic L because the drug plans are only crediting Vascepa for the MARINE indication..and that will not change until next year..For H&R, things are even bleaker..They will not be getting the R-I upgrade next year. They will see their scripts converted to Gen L unless they can beat Gen Ls price and to do that they will be throwing away most of their profit..
In the meantime Vascepa will be getting the R-I CVD label indication and they will no longer be competing with Gen L...Because Gen L does not have the R-I label expansion..Brand Vascepa will not have any competition and will be most likely Tier 2..
":>) JL
lb...
Quote; "f something is so egregious (i.e. Du's decision or other decisions that are made not based on law....but rather because of personal preference or social agenda of a judge) (or libelous messages that destroy life and property are pushed by congressmen based on egregious lies) then there should be some kind of accountability.....as there would be for any normal citizen."
You got that right...
":>) JL
Why the generics might change their minds and agree to a settlement..
This may seem somewhat incredible...but these are the facts..and they suggest the generics will have won very little even if the AC affirms Du...
Fact one So called "health care plans" usually do not cover the cost of prescription drugs..The exception are plans that are offered by hospitals or other health care providers like Kaiser or the Mayo Clinics which sell their own drugs...Most Medicare plans do not include prescription cost and as a user you must get a a Medicare D. Plan (Drug plan) and they are sold separate from your hospital or doctor plan.
Fact 2..Drugs are categorized by Tiers...Which reflect out of pocket expenses for individual prescription drugs..Tier levels run from Tier 1 to tier 4..The lower the Tier the lower the drug cost out of pocket for patients..Out of pocket cost for Tier 1 might be as low as no out of pocket cost Tier four might be as high as $200/per month..The situation gets complicated if there is more than variety of the drug. For example a generic version and a brand name version..There is also situations where two drugs which are chemically different but have the same clinical effects..The situation can get complicated..Two drugs different with a different API can used to treat the same disorder with equal effectiveness. In these cases their are rules..Many of these are state laws..and even though historically generics are awarded Tier 1 designation...When there is a competition "tie goes to the cheapest price". Drugs which have the same efficacy or indications as a lower cost drug are usually classed as Tier 3 or Tier 4.. A drug for which there exists a cheaper alternative..
Fact 3..The generic court case was about the Very High Trig indication.( the MARINE indication).Very high trigs are known to increase the risk for acute pancreatitis..Generics have not won the right to sell EPA for reducing CVD event risk reduction..(the R-I indication)..of course as educated investors in Amarin know..there is a loop hole here which is the fact that scripts once written can be used "off label". And clearly the generics plan was to use the off label use to steal Amarin's property...
But there is a large fly in the ointment..and that is generic Lovaza (GL).
Right on cue..It turns out the Lovaza and Gl (generic Lovaza) have exactly the same FDA Indications and Usage label..Word for word...as The Marine Label which Hikma and Reddi are required to abide by..While it is true patients can use the drug for the CVD reduction..H and R are required to use the Marine label...and as such unless they can undercut the price of GL..then GL will get the tier 1 label price and generic Vascepa (GV) will likely get Tier 3 Or Tier 4...The Tier labels are not determined by the drug company they are controlled by the drug plans and state laws..H and R can not go to the drug plan and say..We really are prescribing this for CVD event reduction and know the patients will convert (go off label)..The Reno trial only allowed them the Marine indication..and if their true intent is to steal the CVD indication..Then they are infringing on Amarin's patents...
It is very doubtful Reddi and Hikma can sell Vascepa for a lower price than Lovaza..And be apprised the costs differentials between the more expensive alternative drugs are usually very substantial..Amarin knows from bitter experience..It has had to compete against L and GL for several years because what Amarin and L and GL all had in common was the Marine Label..and V was not the cheapest..And believe me the drug sellers did not do any favors for Amarin..Even though they knew V lowered CVD event risk...The drug companies do not care if a drug cuts hospitl costs..Not their problem..
":>) JL
Porter...
Nice picture...
The whole market being taken out to the wood shed today..
My old broker Bruce R. (RIP) used to say.."It's all over..They've taken all the money"..
":>) JL
Hamoa..
Quote: "Regarding the generics' response to Amarin's opening brief, which is due next week, I think it's highly likely that the generics will focus on the district court's agreement with their argument that the prior art had only to make EPA treatment without LDL increase obvious as it applied to a subject with triglyceride levels of exactly 500 mg/dL. Judge Du concurred with the generics' argument that it would be error to find the patents in suit valid based on arguments related to what had historically happened to LDL levels in severely hypertriglyceridemic patients treated with triglyceride lowering therapies."
I can not agree with your opinion..I think you are trivializing Amarin's argument by claiming the results do not require specific trig levels. But can be extrapolated over a range..and do not require levels of 500mg/DL.
The reality here is that Du based her opinion on faulty reasoning and this was not related to specific lipid levels...But on a failure to appreciate and understand the Friedewald equation..Put very simply the Friedewald equation states across a fairly wide range of lipid levels that lowering trigs will increase LDL-C levels in proportion to the extent of trig lowering. Critics of the Friedwald Equation (FE) are quick to point out that the FE is not accurate for all levels..This is true but the results for extremely high trigs can be obtained simply by changing a constant.
Du's argument was not that she could extrapolate the trig level and reach an obvious conclusion..Du's "error" was she did not understand the ramifications of FE..The most important being the increase in LDL-C by trig lowering was proportional to the decrease in trig levels..Hence if DHA lowered Trigs at a given dosage more than EPA did. Regardless of dosage: then DHA should raise LDL-C proportionally more than EPA would...She completely disregarded that fact and concluded EPA obviously had special powers..
The reality is that how EPA actually reduces Trigs with very little increase in LDL-C is not easy to explain even though we have a decade more of medical science..That is..It is not obvious even today how EPA works..And that is a very strong argument..
":>) JL
HK...
Quote: From IWIK..."I don't know if it is proper to refer to the Friedewald equation, but LDL-C est as = TC- HDL-C - (TG/5) suggests that decreasing TG by 21% more could increase LDL-C by 4.2% more...."
Simple Arrhythmic. The Friedewald equation
[[LDL-C = (TC-HDL-C) - (TG/5)]]...TG is trigs
A decrease in the trig levels of 21% should raise the LDL-C by 4.2%..The fact DHA lowered trigs more than EPA (in Mori) and also resulted in an expected (4.2%) increase in LDL-C levels is consistent with Friedewald..Mori does not offer any proof that EPA had the special ability to lower Trigs and not increase LDL-C..
Conclusion..Du is mistaken in her interpretation of Mori..Mori says nothing EPA's special effects regarding trig lowering.
":>) JL
Slim///
You see what's happening on Xr.today..This baby is going is stronger than horse radish...
":>)JL
KIWI..
Quote: "Can you explain to me why you pay so much more than poster North for Vascepa?.
Could be any number of reasons..North worked for J&J I believe and they might have a better drug plan..I don't know that North might have worked for the government..
I have Silver Scripts from CVS..Check out the Tier..
Most people don't have Kaiser which is a total health care vendor..Most of us have drug plans that just sell drugs and they don't give two hoots about the drug lowering hospital costs.
Quote: "GV to be more expensive than G Lovaza . Doubt if it will be a huge difference ". There is a Marine market for G Vascepa...You might be surprised generic L Tier 1 might be $5-10$ co pay and GenV might be $150 a month. as a tier 4
":>) JL
KIWI...
I love your "Belle Indifferance"..
Did you read the two labels..The indications and usage are exactly the same. The Tier decision is not (as you and everyone else knows) going to be made by the PCPs its going to be made by the drug companies.
And all they care about is the cost..Look at the history of Vascepa vs Lovaza. How many tears on this board have been shed when Lovaza and gen Lovaza scripts were kicking Vascepa scripts to the curb.
It didn't make any difference and they stuck Vascepa at Tier 4 even when they knew about the R-I CVD results.And the wonderful fact V did not raise the LDL-C level,,.These drug companies are not in it for the love of fellow humans...They are "Business Men...
And keep in mind...The Generics are only supposed to be selling the drug for the ANCHOR indication..
My last three month cost for Vascepa was $580..dollars...The R-I study results are out and the Tier level is still Level 4...
":>) JL
HK..Regardless of who the inventor was..and JZ was the main author of a lot of the patents..He was not the "Lone" believer that EPA could lower Trigs and not raise LDL-C...There were others including me that knew EPA could could lower trigs, and not increase LDL-C to any great degree...
What is a fair statement is very few people did believe and certainly most of those knowledgeable in the field did believe lowering trigs reflexively increased LDL-C..And this was predicted by the Friedewald equation..
To this very day it is not completely clear how EPA actually exerts its magic..The reason why lowering trigs should raise LDL-C levels has to do with the fact VLDL, the lipoprotein that conveys trig in the circulation is mainly APO-b..and so is LDL which conveys LDL-C (low density lipo protein cholesterol..Add to this VLDL also conveys some LDL-C...In real life physiology as the trig content of an VLDL particle drops the VLDL particle will convert into a LDL-C particle..This is reflected in the Friedewald Equation. So Du was very wrong about her conclusion.."More mysterious was how EPA could lower Trigs and not increase LDL-C..You will not find many explanations in the literature...
My own personal opinion is that lack LDL-C elevation is related to the anti inflammatory effects of EPA...What is know is both sugar and trig levels are controlled by by the activity of enzymes..Insulin for sugar and FAS (Fatty Acid Synthase) for trigs that increase the removal of these energy sources from the blood..Insulin activity is diminished by high Systemic Inflammation (SI) and so is FAS...So EPA's actions on SI could have a statin like effect. lowering both LDL-C and total Cholesterol...This also might be an explanation of the infamous mineral oil issue..The higher cholesterol levels in the mineral oil arm.. Might actually be a reduction of Cholesterol in the EPA arms.
Du's opinion that knowledgeable people knew EPA could lower Trigs and not substantially increase LDL-C is erroneous. There were a few people who did, but very few..It is still somewhat of a mystery...
":>) JL
HK....
Quote: "in fact I spoke to one of the inventors on the patent who drove the research and he informed me that as you say he was a lone believer at one point that EPA to lower high TG's and keep LDL down was a fools proposition."
I know for a fact this was not the case...
":>) JL
Jas...
Quote: "The general market will eventually look at AMRN as a value stock, and it's valuation of $3bn market cap is a fire-sale due to appeals over-hang; however, standalone Europe valuation is close to $15bn or ruffly $50 PPS."
Now I think you are thinking like a player.....
The AC is a total "crap shoot"...The real issue here is that Off Label scrips are perfect legal and widely used..The iniquity (unfairness) here is the pretty much close to worthless MARINE indication can be used to shoe horn Marine into the R-I indication.
I am surprised that Amarin has not taken a close look at the MARINE label as a dodge for the patent validity..
Marine Label --------------------------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)
"Has not been determined...
Compare this label with Lovaza..
Lovaza Label................INDICATIONS AND USAGE --------------------
LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally
EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). (1)
Limitations of Use:
• The effect of LOVAZA on the risk for pancreatitis has not been
determined. (1)
• The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined...
Maybe I am missing something here, but the Vascepa Marine label and Lovaza label for indications and usage are the same...
This may have escaped everyones' attention but it has some very significant consequences for the generics...Tier pricing is determined by the cheapest alternative and I believe generic Lovaza will be be able to undercut the generic Vascepa price..And keep in mind that even if generic V can be converted to off label R-I Vascepa..The generics have not won the right to sell the drug for the R-I indication..And if Lovaza can beat Gen Vs price then Gen V will be selling at a higher Tier (ie Tier 3 Or possibly Tier four 4)..And this real possibility could encourage the Generics to settle..as selling the drug without being able to convert to the R-I indication will not be be very profitable..
":>) JL
Thanks for setting the record straight...The space program is picking up..Lots of excitement down here along the "Space Coast"...Has to be good for Sigma...We don't need any major blow ups...
":>) JL
Todd...
Quote: "Everyone seems to say no - because it would be new evidence. That just seems unfair."
Not everyone says no..Where do you get that..The subject was discussed in the DC trial and was the lynch pin of Du's flawed verdict..This is not anything new..and will definitely be allowed..
":>) JL
slim...
I am not a huge JT fan. I think he could have done some things differently..I think he should have taken some of his millions an and used them to improve his public speaking..I think he used the companies treasury as his personal account..That said he did a lot of things right. I have never pined for a buyout..so that puts me on a list for many of the posters on this board..
I think JT deserves high marks for handling the legal situations..(I know,, I know)..He bought and paid for the very best legal representation. For the most part that was Chris Sipes...Although Sipes clearly made a huge mistake in picking the 9th District...But who in his right mined would have predicted the craziness of Judge Du...Fortunately she made some insane errors and unless we get another douzey of a judge she should get reversed.
I'm with you Slim as far as losing a pile of money lately. And that does suck. I think we will see more support from the drug industry, the clinicians and maybe the USPTO..and God forgive the FDA..
The best low priced hedge is ;probably the "Kiwi solution" of diversification...I think you know what I mean..Amarin is no longer my largest position..
":>) JL
raf....
Quote: "How do you think Singer will introduce this to the Court?"
As pointed out by several credible sources including the medical sources paper..AMA..This is not new evidence...It is evidence discussed extensively in the DC trial..And is such Singer will have no problem introducing it in the AC trial..
Why is it important?...Two reasons...first MORI lacks credibility because it is not a peer reviewed article. MORI is merely hypothesis generating and makes no clear distinction between the actions of EPA vs DHA.. MORI can not make the argument (clear and overwhelming evidence) because it is not powered (designed) to do so..Second reason..The judge (Du) made a fundamental (mathematical) error in declaring that MORI showed statistically significant evidence. MORI did not show stat sig between the the control and the active arms..
A factual error might not be grounds for reversal in every case..But in this case Du based her entire thesis on this fact..I can not imagine the AC not reversing Du..
This in addition on her procedural error of transferring the burden of proof on the patent validity from the defendants to Amarin...
A real CAMFU
":>) JL
HK...
From your post: Quote
"(3) Every paper between 2000-2008 including American Heart Asssociation state of the art guidelines in treating Hypertriglyceridemia, and POSA state of the art reviews/ meta analyses say unequivocally that all omega3 formulations will increase LDL as a consequence of how VLDL is metabolized.Where is the obviousness or the hint of a soupcon of evidence that EPA could do it without increasing LDL and lowering ApoB anywhere inthe litearture? As the Curfman article points out, MORI taught nothing and quite possibly taught the opposite of what Du thought it did."
Let me just include one other piece of evidence..And that would be "Lovaza" which was the number one Omega three trig lowering drug, and may still be..Attempted to seek an FDA label expansion (sNDA) for trigs over 500mg/DL during the stated time frame and received a CRL* (* Complete Response Letter) from the FDA because although Lovaza was actually more effective on a per dose basis than Vascepa, at lowering trigs. Lovaza raised LDL-C to the extent FDA rejected the label expansion. And informed the company the FDA would require a CVOT (Clinical Outcomes trial) to substantiate that Lovaza's therapeutic benefit outweighed the risks..
As a further note FDA's action in reneging the ANCHOR SPA was based on on three CVOTs..THRIVE, AIM HIGH and ACCORD. All of which were about trig lowering. The results of these three CVOTs Convinced the FDA that Vascepa's therapeutic benefits were not in the least bit OBVIOUS. Quite the opposite..And certainly the FDA knew about MORI...A "hypothesis generating" non peer reviewed paper published in an Australian nutritional journal..Right next to an article explaining what a "vegetable" was..(I can't make this stuff up).
":>) JL
Marjac...
Excellent post as always..What bothers me about the Du presentation is not the stupidity. Stupidity is the most important driver of human history. Stupidity has all the advantages because it does not have to be correct or follow any logic. or conform to any direction..
The problem I have with Du is that all her errors were made in the same direction. That direction was to support the defendants argument and damage Amarin...How can that be simply stupidity. An impartial judge that does not understand the law would have a equal probability of making errors that would injure both sides. In the Du bench trial that was not the case..her errors, factual and procedural, would all in favor of the defendants..and that is a strong argument that Judge Du was not impartial. I do not pretend to know Du's motivation..But it is clear and overwhelming evidence that DU was playing for the generics. Judge Du clearly took the blindfold off Lady Justice eyes..She violated the Ninth Amendment Thou shall not bear false witness against thy neighbor...
":>) JL
HK...
Good idea...Get the Journals to educate these judges re: the rigor of Peer Reviewed Journal articles..and why not only did Du make serious factual errors. Her citations were not peer reviewed and were only "hypotheses generating" articles..Not appropriate for the type of evidence that Du was basing her decisions on...
Her complete decision is a pile of nonsense....
":>) JL
lizzy..241
Quote: "Could these new findings by Dr. Bhatt et al be a cause for a mistrial??"
There is nothing new here..other than it is Bhatt (Harvard ) and the AMA on the phone...
The trial is going to an Appeal..We are getting some powerful allies..We could use some more..The FDA and the PTO would be a big help..
":>) JL
juslin...
"So since there was a statistical error in the original paper referenced by Du and if the appeals court accepts it, does this raise the chance of a remand back to Du reconsideration?
No Remand..The rule is legal issues based on interpretation get a remand..Factual errors get a reversal...
The only thing obvious about the Du trial is she was out to screw Amarin..Fortunately she is too stupid to pull it off..With the AMA and Harvard getting involved..And pointing out..Her little game might have far reaching effects on medical research. Its going to be very hard to sweep this under the rug..The FDA needs to speak up at this point..Castrating the H-W legislation by giving Brand drugs away to generics is not going increase NDA applications at the price FDA has them set at..
And where has the USPTO been hiding out The last couple of months..They must be all Eunuchs..To let some moron judge invalidate seven of their patents and not make squeak about it..I grew up thinking the USPTO was the final authority on patents in the USA...Now I know it is actually know it is an affirmative action female judge who has to rehearse to point up that is the final authority..
Good Lord...
":>)JL
Porterhouse...
You bitch and people sell...Watch what you post..You are not helping with your turd talk..
":>) JL
Slim...
Actually INSG is up at this point a fraction above the NASDAQ...so it is marching in the Parade...
My personal favorite holding is EXRO F..a Canadian stock that promises to increase the the efficiency of electric motors over the range they are asked to operate..Electric motors are more efficient within certain ranges...For example Wind generators, or electric car motors or any electric motor that operates over a rage of speeds..EXRO changes the coil configuration to optimize power or output...in motors that operate over a range of speeds..
For example wind mills prop speeds vary with the wind speed and are more efficient at certain speeds..EXRO's technology can increase the output by altering the coil design for non optimal speeds..This would work in electric cars..or boats..and many other aps...
Most people do not know about this stock..
":>) JL
Jas...
You have not one shred of evidence that Amarin turned down a settlement..I don't think Hikma and Reddi were in the least bit interested in a settlement..They knew something we didn't...Guess what that was...
":>) JL
zip...
I think we agree on most aspects of Amarin..But I don't agree with you on this issue...If she was mentally fatigue or upset she should have recused herself on the basis of being incapacitated.
When I was living in Wellesley in the 1990s...My and my family"s closest friends were a Federal Judge and his family..I can not even begin to imagine the judge, his wife Ellie and their children being in all the crap Du and her family were are involved in ...Drug addicts and police shoot outs..It seems more likely she would more comfortably fit into "Goodfellows" than being the chief justice of the ninth...
She was also sanctioned earlier (a long time before her husband died) for overturning the conviction (on a technicality) of a bank robber who killed an FBI agent during the commission of a bank robbery..She is a real piece of work.
This is Reno we are talking about (Vegas without the Bellagio and Money).
I bet she lobbied to get the Amarin trial and did not give two nickels about her deceased husband..The more I learn about this woman..The more I think she would not have blinked an eye over deliberately tanking this trial..Her opinion has deliberate written all over it..I loved to see the dossier the FBI has on her..
":>) JL
marjac...
Quote: "There has still been no accountability for the 74% reduction in the share price since the FDA approval high."
First of all I am a fan of yours and appreciate all your valuable post and inputs...
That said what can the company possibly say that can mitigate the suffering? Please help me here..I personally think maintaining silence is the right thing..This is like Pearl Harbor...but at the same time it is not like Pearl Harbor..because its not a foreign nation..It is our own government.
What do you want JT and the gang to say.."We didn't figure on a Judge that was either..
(1...A dumb MF whom didn't know shit about the law.
(2..A political appointee who had an agenda and jettisoned all guises of impartiality..and proceeded to carry out her game plan..
(3 ..Another crooked public official who sold her verdict to parties who wanted the generics to prevail...
If anyone should be required to make a statement it should be the court..How do you let this bullshit happen..I don't think you (Marjac) and I thought this could happen (sorry if I am wrong about you)..I don't think the company thought it could happen..I think if you talked to Chris Sipes he did not think it could happen..I think if Amarin is smart right now they are lining up some serious lobbyists and influence rs and some private investigators...And if I was doing this I would be keeping my mouth shut..
Also my bet is Hickma and Reddi both knew the "Fix" was in and that's why there was no "stinking" settlement..Like the one TEVA made..
":>) JL
NickHouse...
When you are quoting another poster, " I believe Mori was published in a nutritional magazine of all things."...Its good manners to quote your source..That would be me in this case...
TIA..":>) JL
"The weed of crime bears bitter fruit."
I remain unconvinced Judge Du's surprising verdict was simply the product of her not only being well versed in Patent law: or not being very bright..I also am not impressed with the notion this was simply an activist judge expressing her political views...
The verdict here was less of a treatise on Patent Law and more of an outright theft of property..Du's errors were not misplacement of punctuation marks, or misspellings...They consistently favored the defendants and injured the plaintiff. To me that conveys proof that there was an agenda here...And that Du was not in the least bit interested in being impartial (the first and most important requirement of a judge). This and the scope and magnitude of her errors of procedure and fact are so egregious..That to my mind she was motivated (strongly motivated) to award the the rights to Amarin's property to the generics.
Follow the Money...
If I were the company. I would be forced to consider the possibility that this judge was paid off..It would not be the first time a judge was persuaded to loosen up on her ethical requirements. I think the company would to do well to hire investigators..
I'm sure Du understood no matter how much she handed the generics with fake law and factual errors..Once she rendered her verdict. The company would have a difficult time reversing the opinion in The Appeals Court.
IMO her opinion and actions in the Reno trial are simply theft of property...my property and the property of other shareholders. She is no less of a criminal than a man holding a gun in a bank or an ally..Its just instead of a gun she uses her gavel. And she is downright arrogant about the whole thing...
":>) JL
zman...
Now is not the time to be shy...Speak up and tell us of your clever plans..The word might get to managements ears..
":>) JL
HK...
Quote:.."But if an Appeals court allows an incompetent parvenu like Du to set precedent on the basis of both procedural and scientific errors we have reached the zero mark on the justice scale."
Yes Justice would not merely be blind. It would have to be blind, deaf, senseless and stupid..These are the descendants of those who burned the Great Library at Alexandria...
":>) JL
alm2....
I have read the information....There are a very few diseases which target the small blood vessels..But one of them is Scleroderma. Scleroderma is thought by most people including clinicians to be a skin disorder, but in reality Scleroderma is an inflammatory disease which effects the arterioles (the small arteries). Scleroderma effects most of the body..because of the general increase of inflammation in small arteries..In this sense COVID-19 might have similar, but, more more dramatic effects..In the clinical trial of one patient with Scleroderma that I treated with Vascepa..The clinical response was very dramatic..The patient had very limited range of motion..And required "devices" to put on her shoes or socks..Her gait was unstable and she was unable to walk without a stabilizer.
After a month on Vascepa she showed dramatic improvement in flexibility and mobility..Her GI system was better..I have not followed up on the Scleroderma boards..This was six or seven years ago..I have not followed up with the patient..(I am retired).
This is interesting, but is only anecdotal and does not provide any proof that V would work in a more acute situation..But it is a tantalizing tidbit...And I would not be surprised if Vascepa did provide some therapeutic benefit in COVID-19...And yes it could be fairly dramatic. Probably more effective if EPA is given very early in the disease rather than in end stage..Not sure where statins come in, but throw in the kitchen sink..
":>) JL
HK and Montana...
Nice going guys...Regardless of the ridiculous legal interpretation of
"Obvious"..The real definition of obvious is "not controversial."
But what is definitely not obvious is 2 plus 2 equals 5...And that is what Du is arguing..Before you can claim obvious you must get your facts straight. Because if your observations, facts or solutions are incorrect and you are claiming these are obvious..Then you are actually arguing the correct answers are not obvious..Think about it..
":>) JL
Some idea's
Posters have asked the question is some of our problem due to the fact Amarin is Chartered in Ireland and Great Britain and is that hurting us in the Fed Courts..
A good question..Amarin benefits from lower taxes in Ireland. And while that might be an accounting plus..Is this tax strategy depriving us of the attention and protection we might get if we were an American Company..And should we be considering rechartering in the USA..
The current legal situation stinks to high heavens..Maybe we woul get more protection if we were paying taxes..Maybe we are being punished because we are not paying taxes.
I have been a long time supporter of Amarin mangement..But their silence in the face of this whirlwind speaks volumes.They are )as Gecko said) "Walking around blind without a cane"
.JT seems mainly focused on raiding the company's treasury to fill his pockets..We need more than just hiring a new lawyer..The company has maintained radio silence for the past six months. While the company burns...We need some proactivity..We need lobbyists and media experts..The best plan now is to get this terrible story out in front of the American people..I believe that Americans as a country believe in "fairness"...And regardless of all the Latin trimming on the Amarin V. Generics trial (all the indicias) what is happening is not fair or right and Amarin needs to get that out in front of the American citizens..I believe the media would eat this stuff up..A trial that is decided based on factual errors..An ignorant judge refuting the opinions of both FDA and the USPTO...This looks far more interesting than stories about how rich people can use their money to get their kids into Ivy league schools (shocking)...
:>) JL