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The patented gelatin capsule makes a difference...The billion dollar questions is.... how much of a difference?...It is incumbent upon Amarin to answer this important question ASAP.....and to publish the results for all to see...including the FDA.
If what I suspect is correct, gV may be dealt a mortal blow.
Right now it seems to be a two against one stand off...i..e. PWO and Ekman against Denner...I'm not sure how this impasse can be resolved in the short time left before the ASM....Perhaps Enright and Zulueta could pitch in to assist in negotiating a compromise.
Also, a delay in the date for the ASM might be a helpful step towards reaching a resolution.
It seems as though the present BOD will be inevitably be re-elected at the annual meeting, as is almost always the case...However those, who are now voting to abstain, are really casting a vote for change.
It would be advantageous for a new meeting to be called by Denner ASAP after the ASM and for a new roster for the BOD be presented to the long suffering shareholders for a vote.
If the dilemma surrounding Vascepa patent infringement by generic Vascepa could be successfully put to rest, I believe that a larger study than the small Brave study would be promptly initiated by either Amarin or by a BP to test Vascepa's efficacy in ameliorating the AD problem, which is crippling millions of Americans' lives and those of their families.
KM has expertise in EU marketing and regulatory affairs...If Amarin is to remain as an independent company, it would be optimal to have someone with expertise in marketing, regulatory affairs, and legal issues, as they pertain to the U.S., share the helm with KM.
PWO was hand picked by his friend, Ekman, the former COB, to replace him as COB...However,Ekman remains as a member of the BOD after resigning as COB....PWO has been with Amarin for less than two quarters.
That should give us a hint as to who the prime decision maker/s are at Amarin at this time....and IMHO they are not KM.
I can not envision a company more in need of a different management structure, which I hope Denner can provide.
It would be optimal if PWO, Ekman, and KM could see this and clear the way for Denner to right the ship.
KM entered a dire situation a year ago and has performed well...
1. He introduced Vaskepa to the German market.
2. He arranged for government payments for Vaskepa in Sweden at a fair price...and got approval in the U.K.
3. He has made good progress on approval in France and other EU nations.
4. He has taken necessary steps to cut overhead.
5. He has also taken necessary steps to stem the tide of generic infringement by offering rebates to insurance companies in the U.S.
Having recently assumed the job of CEO, he was no position to correct the errors of commission and omission that the entrenched BOD had made over a period of years.
He could be faulted for continuing the GIA policy, but it was in force when he was appointed as CEO...and he had little authority to turn it around in the less than a year that he was on the job.
QUOTE..."LARS EKMAN - BOD COB SELLS ALL OF HIS STOCK IN THE $3s (1,070,000 SHARES) BEFORE Q1 22 EARNINGS ARE ANNOUNCED".....
Two doctors, who have shown zero interest in the products and goals of Amarin are...Steve Nissen and Lars Ekman...IMO neither of them should be nominated for, nor elected to, a position on the BOD of Amarin.
Hikma is depending on the SCOTUS NOT giving Cert to our case...because they understand that...if the court does give Cert, they have a good chance of losing the case.
If the SCOTUS gives Cert to the EPADI case, it will not be heard until the next session starting in October 2022...By that time, Denner should be in a position to make decisions for Amarin...One of his first decisions might be to join EPADI in our appeal...something that Ekman and PWO have so far refused to do.
Nsleven..."If Health Net loses it will set a precedent."
I hope you're right...but I also hope we're out of Amarin by the time the decision comes down....especially since I intend to buy stock in whichever BP buys Amarin.
Vascepa has a great future, but not with Amarin.
liz...Don't give up on Vascepa approval in China coming during this year.
Given China's approach to combating Covid, they should have millions of people, who are at CVD risk, taking Vascepa.
BB..."It has a safety profile similar to Aspirin"...Vascepa actually has a safety profile BETTER than aspirin.
As an ophthalmologist, I had a patient, who, unbeknownst to me, was taking 35 aspirins daily and died of pulmonary bleeding(found at autopsy)...I know of no incidence of Vascepa causing enough bleeding to result in the death of a patient.
When I had asked him, prior to his death, what medicines he was taking, he never mentioned aspirin, because, as a relative told me after his death, he never considered aspirin to be a medicine.
Pdude..."For me it’s been 8 long years but I’m willing to go 2 more for a true or maximum return."
I'd be willing to wait two years more, but not much more than that....At the Q1 C.C...KM spoke about a combo drug being available in 3 years...after waiting 12 years, I'm getting impatient.
If we're talking about insider trading , why not discuss Ekman's position as an insider(i.e.the COB of Amarin} when he sold all of Sofinnova's Amarin shares, having advanced knowledge of what was likely to be revealed to the unsuspecting Amarin shareholders (and to Wall St.) during the Q1 C.C....and which, inevitably precipitated a collapse of Amarin's stock price.
Per Wold Olsen was appointed to the board in January 2022 by the Amarin COB, at the time, Ekman....Ekman, as managing director of Sofinnova Partners,was in the process of selling all of the fund's shares of Amarin... Ekman retired last month...Per Wold Olsen advanced to the position of COB of Amarin upon retirement of Ekman last month, probably under the imprimatur of Ekman.
Draw your own conclusions about the present board's skirmish with Denner.
Denner is involved, like the rest of us, in a game of risk and reward...Pie in the sky estimates of valuation are not to be taken seriously...Estimates of what a company is valued at currently... and what it might be valued at in the future...are often very different..I rely on Denner to look at both of these valuations and make the right conclusions as to a what a fair selling price would be for Amarin to be sold at and for a BP to acquire at....In light of that, I have decided to cast my vote for Denner to make the correct decisions.
liz...The Hikma-Healthnet infringement conspiracy case is separate from the ninth circuit fraud case, which EPADI is appealing to SCOTUS.
To make an AG profitable, you need to compete on price and/or supply...
Before the skinny label appeared on the scene, Amarin made contracts for the huge supply of API they envisioned would be necessary...Now they need to have an AG to supply the U.S. along with Vaskepa for Europe and low priced Vascepa for China and poor countries in ROW.
This will create a much greater demand for API than will be the need for the three gV competitors....It will also make it possible for Amarin to demand lower prices for their API than their generic competitors can demand...due to Amarin's ability to purchase higher volumes of API at better discounts than the competition can demand...This will enable Amarin to price their AG on the market competitively relative to the price of gV and still make good profits from higher volumes of sales.
Reasons why Denner invested in Amarin...
1. to take Amarin private...possible, but doubtful
2. to wait for GIA in Europe to be profitable...doubtful
3. to sell an AG in the U.S....doubtful
3. to break even in the U.S. with branded Vascepa...doubtful
4. to wait for a combo drug to be approved and marketed in the U.S....doubtful
5. to wait for another indication for Vascepa(e.g. Alzheimers, cancer, dry eyes, arthritidies, Covid etc.)...doubtful
6. to wait for China and ROW to show a profit...doubtful
7. to wait for court relief from "skinny label" theft of sales of branded Vascepa...doubtful
8. to sell Amarin to a BP...PROBABLE
lizzy..." By choosing the abstention vote it's a vote for Denner's future picks during the special meeting whenever he decides to call that meeting. "
Even better for shareholders.. would be for Amarin management and Denner to come to an agreement without the need for a special meeting.
Quote from Sarissa..."Given ongoing discussions, we intend to vote "ABSTAIN" on all matters at the annual meeting. We believe this reinforces our message that CHANGE IS NEEDED as we give the board the time to add shareholder representatives to the board."
I believe this is a premise that few will dispute.
The Amarin board was asked by Denner to avoid a special meeting after the ASM...by negotiating an agenda acceptable to both him and to the board... This being unsuccessful, we are now at the brink a confrontation between the two.
one...The current"skinny label scam" is making brand drug companies hesitate to do research on potentially vital drugs.
They contemplate that a skinny label generic drug might make them susceptible to a challenge, which would reduce the value of a brand drug they already have on the market.
I would like to see Marjac on the board...He has contributed his time, money, and enthusiasm for the cause of justice for Amarin...Whether he wins or loses at SCOTUS...he has demonstrated his dedication to Amarin.
KM is in a delicate position...He needs to choose between the current COB and Denner. His choice will affect, not only his future, but also the future of Amarin.
What this boils down to is a choice between J.T.'s plan to GIA, which was made obsolete by the adverse Marine patent decision, and a sale to a BP.
sstyles... My shares, my wife's shares and my daughter's shares are voted to 'ABSTAIN'...and I intend to ask that my grandchildren's shares be voted to 'ABSTAIN.'
Past managment strategies have failed and it is time for a new approach to make Vascepa the potential blockbuster drug that it deserves to be .
My assumption is that Denner is content with present management...Otherwise, we would have heard from him...If the present management is OK with Denner, its OK with me.
I think we will be hearing more about Denner's plans for Amarin's future after the annual meeting...rather than at the meeting or before the meeting.
Bird...I have owned Amarin shares for over a decade and never received a call to remind me to vote....WHY THIS TIME?
Nsleven..."I asked him why Amarin was reaching out to shareholders. He claimed not to know"...
Information being withheld from shareholders on a vital question like this is reprehensible(if not illegal) and needs to be addressed by Amarin management ASAP.
I assume that Dr. Denner has friends on the Amarin board and on funds,which own a large enough number of shares, so that he does not have to depend on support from us retail investors to enact policies he favors.
Rose...QUOTE "Not long after Sun bought Ranbaxy from Daiichi Sankyo in 2014 the Japanese company was hit with claims against the Indian generics giant."
Since Amarin embarrassed the FDA by successfully suing them over first amendment rights in 2016, Amarin may not be on the FDA's favorite company list.
Remaining questions on the combo drugs
1. Will the FDA require event studies or lab studies or no studies...once the combo drug is approved in Japan?
2. Will the combo drug include the enhanced EPA that Mochida has invented...i.e. to make it a once a day med...or just regular EPA?
3. will the combo drug come in a blister pack or a statin-EPA capsule?
4. Will there be a single strength of a statin-EPA combo...or different strengths of statins in several combos, each with 4 grams of EPA?
5. Will there be several strengths of EPA in statin-EPA combos?
My present preference...start with blister pack containing several strengths of statins with 4 grams of EPA....Then upgrade with once a day statin-enhanced EPA...combos.
HDG...QUOTE..." I am not aware of the full details of the Hikma case, so could not say or deny it is the "same" or different situation but I am sure an "explicit" promotion by Hikma should be exist to win the case."
This turns on what is meant by "explicit"...Hikma bragged in 2020 in a public a meeting of financial analysts that.... "Company forecasts sales as high as $700m after regulator grants broad label."
This figure could not be realistically achieved by selling gV solely for Rx for the high triglyceride indication, which is only 7% of the Vascepa market...It is a very "explicit' statement of Hikma's intention to infringe on Vascepa's CVD indications, which are 93% of the market.
This evidence was introduced at the Amarin vs. Hikma and Healthnet trial. and was convincing enough for magitrate judge Hall to find for Amarin.
When Vaskepa is finally approved the by the regulatory authority in China and prices are being negotiated, Dr. Nessen will probably appear on the scene in Beijing to push the narrative that Vaskepa is merely a fish oil and Amarin's R-IT study achieved success in reducing CVD, only because mineral oil was used as the placebo.
China is a huge market, potentially rivaling the U.S. and the E.U. in importance... Amarin needs to have a representative in China..dealing with the Chinese regulatory agencies, with Eddingpharm, with the Hong Kong stock exchange and with other Chinese financial institutions.
Nsleven...There was, in fact, a difference between the Hikma and Healthnet cases...Hikma relied on the often used, but implausible excuse, that they were unaware of any infringement...Healthnet was requesting authorized statements from Docs before agreeing to pay for Vascepa Rx's...which they then paid for, even though the Docs clearly stated on the authorizations that Rx's were for the treatment of CVD, clearly in infringment on Amarin's CVD patents....so Hickma could not use the 'I didn't know' excuse.
Nsleven...We are all aware that infringement is happening every day...Insurance companies, as well as generic companies, are both claiming that they are blameless....The facts are that they are both guilty, and in need of each other to be successful....and unless this infringing can be stopped, it will continue be a profitable and safe tactic, devoid of risk....and a discouragement to innovation.
In the Amarin vs. Hikma and Healthnet case, Amarin alleged a conspiracy by both defendants to infringe on Amarin's CVD patents.
Magistrate judge Hall found in favor of Amarin...but District judge Andrews found Hikma innocent and allowed the case to continue against Healthnet, refusing to separate the two cases.
As a layman, both parties were IMO guilty of conspiracy to infringe and I would like to see further proceedings against one or both parties.
It is not absurd to believe that judges have biases like everyone else...Judge Du may have been biased because she believed in less expensive drugs(i.e.generic drugs)...The appeals' court judges may have been biased because they felt that a young,inexperienced, female judge from an immigrant Asian family, presiding over her very first complex bench trial involving a patent, and who had recently lost her husband, should not be made to look foolish.
It's been two years since her decision and she probably recognizes she would decide the case differently now.