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golf...There are too many variables coming into play this year to estimate a selling price at this time...except to say that I doubt that Amarin will accept any offers for less than double digits.
Amarin has plenty of cash and no debt so there is no urgency to sell at a low price.
Pfizer is interested in Amarin, but Amarin will not sell for anything less than double digits....Pfizer will pay double digits only if we win the rule 60 case...or settle the Healthnet case...or if Pfizer sees evidence of a successful launch in major markets in Europe(i.e. Germany, UK, and France) or in China...This may take as long as a year...but the odds are that it will happen.
LM...Perhaps Berg thinks Amarin PPS is a little low to sell at this time...Its nice to see a kindred soul in management.
Now, if we could see some buying by management with personal funds, it would be even better.
I'm sure that many in management could easily afford to buy 100,000 shares at these prices with no problem.
The PA is a technique used by insurance companies to limit prescriptions for their insured patients, since they know that most Docs do not like spending their time handling prior authorizations...Insurance companies would rather have patients buy OTC fish oils with their own cash than buy either Vascepa or gV....If demanding PA would make them infringers, they would opt for putting Vascepa and gV on the same tier....and hope that the PA policy discourages Doc from prescribing both.
LBL..."can anyone comment on inventory reserves now being well above $1 billion plus?"...The reserves are in anticipation of immanent approval and marketing of Vascepa in China, where CVD is a large problem and where there is a pressing need for Vascepa.
"Splitting the baby"...Judge Du split the baby by invalidating the Marine patents, while upholding the CVD patents...Judge Andrews split the baby by dismissing the Hickma case, while continuing the Healthnet case.
Now I'm worried that the appeals court might split the baby AGAIN by deciding that, while there is merit to the rule 60 claim, they have decided to deny the case because of the issue of standing....a "baby" can have only so many "splits" before it "splinters".
What I don't understand is why Judge Andrews' reason for his dismissal of the case against Hickma...included the wording that the Amarin complaint against Hickma was "MOOT"....Does this have something to do with Amarin's rule 60 case against Hickma still pending, but not yet decided?...(i.e. If Amarin wins, the Delaware infringement case becomes moot)?
Insurance companies will now claim that Amarin is acting against patients' health...Amarin must counter this claim by saying their goal is to make Vascepa more affordable for more patients' CVD...and, by lowering Insurance companies' price tiers for Vascepa, Amarin is making Vascepa more affordable for more patients.
"Health Net's placement of generic icosapent ethyl on a preferred tier encourages the substitution of the generic for the branded drug, including for the patented indication. (Id at ,r,r 145, 151). Together, this is enough to plead specific intent to induce."
Insurance companies, in order to avoid infringing on Amarin's CVD patents, will need to do some new things:
1. avoid asking for pre-authorisation...or
2. insist that each prescription for generic Vascepa state "for very high triglycerides only".
3. PLUS...List Vascepa on the same low tier as Vascepa...so as not to encourage CVD patients to get generic Vascepa for CVD, as insurance companies have been doing.
Pfizer has 5.5 billion shares, which have lost 5 points in the last month.(i.e. loss of over over 25 billion dollars)
The reason for the loss is that Pfizer has to split profits 50:50 with BNTX and BMS on its big winners, Comirnaty and Eliquis.
Wouldn't PFE do better if it could keep 100% of the large(possibly gigantic) profits from Vascepa?
Rose...I note that ONLY Eliquis and Xaralto of these top revenue drugs are for Cardio-Vascular diseases, which are more common than all the other diseases mentioned...If not for Judge Du, Vascepa would be on this list...and it would also be one of the more effective drugs on the list.
dogn...There may be pushback from Hickma and Healthnet in the Delaware infringement trial, but these articles that you quote, put forward very compelling reasons to reduce the number of increasingly frequent cases of infringement,stimulated by a loophole in the HW legislation.
"identifying new uses of old drugs based on AI technology may attract further investment and bring forward additional drugs that are effective against emerging or understudied diseases. Also, brands may view costs of post-marketing studies more favorably if the results of such studies lead to more valuable patent protection. With the Coreg II decision, brands may benefit from additional patent protection in the form of method-of-treatment claims even (or perhaps, especially) if they are not for separate indications.
it may also benefit consumers by protecting research by brands on new indications and other post-marketing studies and by incentivizing companies to repurpose old drugs, including by use of new drug discovery platforms (such as AI-based platforms)"
In the end, patients will benefit greatly if this loophole in HW is shut down!
Thanx KIWI
Thoughts on the Mitigate study:
"The MITIGATE trial is evaluating the real-world clinical effectiveness of pretreatment with an omega-3 fatty acid (icosapent ethyl) to PREVENT or REDUCE viral upper respiratory illness–related morbidity and mortality"(i.e. from Covid)
1.IMO it is more likely that Vascepa will REDUCE symptoms of Covid rather than prevent Covid.
2. Many of the patients in the study have been vaccinated and will have reduced symptoms on that basis anyway.
3. The Mitigate study would have been be more instructive if only unvaccinated patients were pre-selected, randomized...with a group on Vascepa and a group on placebo.
4. the results of this large, but unblinded and unrandomized and not placebo controlled, study may not be definitive.
Having said that, it would still be good if we were to see both prevention and reduction of Covid as a result of the study.
We think of gV being being Vascepa's chief competition in the U.S... but actually the chief competition is generic Lovaza, which has been shown to be ineffective in reducing CVD...Amarin has to find a way to let people and Docs know there is no proof of benefit for CVD from Lovaza....The European medical establishment understands this fact...Why not in the U.S.?
The same is true for fish oils sold OTC....This is a huge untapped market for Vascepa....A large BP could help rescue that market for Vascepa....IT WILL EVENTUALLY HAPPEN!
U.K. Authorizes Pfizer’s Antiviral Covid-19 Pill(Paxlovid)...Fri, December 31, 2021, 7:11 AM...The U.K. drug regulator authorizes the Covid-19 oral antiviral developed by Pfizer as the country faces the largest wave of coronavirus cases since the beginning of the pandemic"
Perhaps the U.K. might also consider using Vaskepa to reduce the symptoms of Covid infected patients, as was reported in the Cardiolink study done in Canada.
The Covington attorney was negligent in that he did not have a copy of the original Kura table with him at the trial...He then could have jumped up to dispute the fraudulently cropped table when it was presented to Judge Du by the Hickma attorneys.
Bottom line...The Covington attorney was not sufficiently prepared and was outfoxed by the Hickma attorney...when Judge Du took the bait and copied it verbatim into her decision.
Raf..."2022 PREDICTION"...Vascepa will be a huge success in China.
Hickma and Healthnet are both guilty of a conspiracy to infringe on Amarin's CVD patents...Both should be held liable for damages if Amarin prevails in the Delaware case.
Healthnet demanded prior approval before paying for prescriptions of Vascepa as well as gV...and they had knowledge of what condition each prescription was written for because of the prior authorization...
Healthnet knew that the majority of prescriptions were written for CVD and they still encouraged these patients to use gV rather than Vascepa for their CVD...by charging a lower price for gV than for Vascepa for CVD patients...there is no way Hickma can deny that fact.
An Amarin gV would be wise in multiple ways...i.e.
1. increased sales in the form of gV means more need for API increased purchases from suppliers
2. higher volumes of API mean lower prices for API for Amarin
3. a coming need in the near future for lower prices for V for Europe and China
4. paving the way for a statin Vascepa combo drug to reclaim the U.S. market
5. making Amarin gV a globally accepted safe and effective drug for every household, as is now the case with Bayer aspirin
Bolio...I agree "The Wash-Sale Rule states that, if an investment is sold at a loss and then repurchased within 30 days, the initial loss cannot be claimed for tax purposes. In order to comply with the Wash-Sale Rule, investors must therefore wait at least 31 days before repurchasing the same investment"
Sellers can wait until the end of January and then buy back prior to Feb 11
For perspective on Wall St. present thinking about Amarin, consider this...
W.S. understands that the Marine patent loss plus generic skinny label infringement has crippled Vascepa in the U.S....We are now delegated to waiting for 12 months for results from Europe and China.
I was buying Amarin shares for about where they are now in price, in the summer of 2018...The R-IT study had not yet been completed and we were about a year away from FDA approval of Vascepa for CVD....The shares grew in price approximately 600% and more after approval.
Marjac or North...When management of a company, for their own reasons, refuses to take action to correct a fraud on the court, can shareholders organize and seek redress?
IMO, a critical factor in the question of the shareholders' standing to seek redress by appealing a decision based on fraud would be.... how flagrant, important, and obvious is the fraud...Do you know of any case law on this point?
I think we are putting the cart before the horse in the rule 60/24 case.
The rule 60 case pertains to a "clearly and convincingly obvious" fraudulent misleading of the court...causing an error in the court's decision. EPADI definitely suffered a huge loss due to the fraud. EPEDI should be granted standing to sue to correct this flagrant fraud.
CBB...I agree, but any potential deal with Pfizer and Amarin will need to wait until after the approval of Vascepa in China.
The good news is that approval of Vascepa in China is expected to come within the next few weeks.
I also believe that the experiment with Pfizer's promoting of Vascepa in Canada will have some importance to Pfizer's attitude towards prospects for Vascepa in China.
Lipitor had revenues in China last year equivalent to 2 billion dollars U.S...This is an indication of the interest in China in reducing the incidence of CVD among its patients and the potential range of Vascepa revenues in China.
ggwpq "a sweetheart deal to Edding."
It WAS a sweetheart deal...At the time Edding entered the deal, Amarin had not completed the Reduce IT study for CVD...Amarin would probably get much better terms if the deal were done today.
The Brave study on Alzheimers disease, sponsored by the VA at the University of Wisconsin, was started in 2016 and scheduled for completion last month in November 2021
If the results of this small randomized controlled study yield statistically significant positive results or if the study just trends towards positivity, it would be worthwhile to use Vascepa, a proven safe drug for many years of use in hundreds of thousands of patients...in an effort to mitigate this terrible disease while a larger study is being completed.
When will we be informed about the results of this study?
My layman's understanding of collateral estoppel is as follows: "The purpose of collateral estoppel is to promote consistent rulings in cases with IDENTICAL facts."
Due to the fraudulent cropping of the Kura table, the TRUE fact of the original Kura table was not perceived by the Judge or by Amarin's attorneys during the case...and was revealed to EPADI only AFTER Judge Du's decision.
The fact being presented in the EPADI rule 60 case...i.e. that important fact being the ACTUAL UNCROPPED version of the Kura chart... is NOT IDENTICAL to the fraudulent fact cited in the original case.
Raf..."Should Vascepa be taken with vaccines to mitigate their risk"?
I have long felt patients taking Vascepa before being vaccinated...or at least, together with vaccination, would save these patients some side effects and even save lives.
A retrospective study needs to be done to show that people taking Vascepa, who have then undergone vaccination, have had less or zero side effects after their shots.
I'm sure the data is there waiting for someone to compile and publish it.
Many patients often switch from their insurance company to go with another competitor insurance company after a short period of time. Unfortunately insurance companies' interest in the health of their enrolled patients is mainly for ONE YEAR ONLY!
Insurance company executives have figured out that what happens to their current patients in 5 years will be another insurance companies' concern and won't, in any way, effect their insurance companies' profits for this year or their job performance ratings.
Judge Du was taken in by the fraudulent cropping in the same way that the Amarin attorneys were taken in.
Bird..."the Federal Circuit would return it to Judge Du, who would then rule that she would have ruled the same way"
To rule the same way(i.e. that the fraudulent cropping of the Kura table made no difference to her decision, Judge Du would need to explain why she reproduced the cropped Kura table verbatim in her decision as the reason for determining that the Marine patents were "obvious"
Whodehouse "I guess I have been a bad boy this year, Santa left GENERIC Vascepa in my Christmas stocking!"
LOL...Santa probably had the gV for his reindeer...and some of the gV fell off his sleigh by accident and into your chimney.
You should return the gV to the north pole with a note to Santa to be more kind to his reindeer and give them REAL VASCEPA!!
Winston and Strawn attorneys, who represent the opposition, have an office in Washington D.C. and would probably prefer that the case be tried in person...to give them the very slight edge that they could go from the comfort and available records of their home or office directly to the trial as opposed to Marjac, who would have to go to the court from a night spent in a hotel room...In a case with as much on the line as ours, every edge,even if very slight,can be important.
I would be pleased to see both parties on remote.
..."Marjac has done an amazing job getting as far as he has with this."
I agree...Marjac's contribution to Amarin, to Vascepa, and to patient care...as well as to shareholders, will always be held as unexpected and really incredible....It could be a subject for a 60 minutes show or for a Hollywood movie...REGARDLESS OF THE OUTCOME OF THE OA!
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Apotex, Hickma, and DRL will compete for patients who are taking gV for very high triglycerides...(i.e. over 500 mgm/dcl)...It does not take a genius to see that their goal is to infringe with their "skinny label" on Amarin's R-IT patents for CVD patients.
There are not enough patients for ONE gV company to make to make ends meet from selling to the very high triglyceride segment of the EPA market(which is about 7% of the total EPA market--the other 93% being for CVD)...let alone for THREE gV companies to make ends meet.
Don't these corporate buccaneers have any shame?...Will they be able to continue infringing with impunity saying:"its not our fault"?
If its not the fault of these gV companies ,whose fault is it? ...Could the fault be a loophole in the HW law, which is not being applied in the way it was intended?
I had the same thought...Apotex may be satisfying the 180 day deadline by showing a vestigial marketing effort for gV...in order to preserve their right to really market gV in the future...if they should so choose.
If both sides argue remotely, that would seem to be fair...If one side argues remotely and the other side argues in person, that would seem to be unfair.
It would be unfair if the Hickma attorney, who, in the briefs, chose to argue for dismissal of the appeal on the issue of standing... but did not choose to argue the appeal on the issue of fraud...then decided to come to court in person to argue both issues...while our attorney decided to argue both issues in court remotely.
I would expect that the court and/or both attorneys could agree on whether the appeal should be argued by both attorneys in person or both parties remotely.
Marjac...I think you have made a wise decision...given the situation with Covid...I plan to be watching the prceedings on videotape and cheering for our side at home...Win or Lose at the OA, you are the greatest.
We are now becoming increasingly dependent on air power...so tilting at windmills is more important than ever.