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One...when you have excess inventory, you need to have a sale...This is what KM may been preparing us for when he mentioned an authorized generic Vascepa during the Q3 C.C.
After depleting all the Vascepa in its inventory, Amarin could then cease selling Vascepa ...and replace Vascepa with MND-2119.
Before executing this strategy, Amarin would need to seek to have MND-2119 approved by the FDA, which I hope will occur ASAP.
MND-2119 is already approved in Japan and is currently being marketed there...With the safety and effectiveness of EPA, in reducing CVD, having been already demonstrated in millions of patients around the world. I would anticipate a positive result for this superior formulation of EPA.
This is more evidence that Amarin needs to find cash to invest in switching to MND-2119 and removing Vascepa from the market.. and thereby cease the enrichment of these Buccaneers...while promoting a cheaper and more efficient form of EPA.
Biogen is spending hundreds of millions of dollars and possibly over a billion to demonstrate the real fact that there is a correlation between amyloid deposits in the brain and Alzheimer's cognitive defects...While this is undoubtedly true, an equally important question is...what was the impetus for the amyloid deposits to start forming in the brain in the first place...IMHO the answer may be...inflammation in the brain.
This is where EPA may be of help....a BP could supply the necessary funds to do the research to show this.
The Eisai-Biogen drug for Alzheimers has hit a snag...
.QUOTE..."Experimental Alzheimer's drug may have contributed to death of study participant, according to reports"
This monoclonal antibody drug seems to be effective in slowing Alzheimers...However it has serious side effects...such as swelling of the brain.. Also, It is necessary to be administered by infusion and it will be very expensive.
If EPA is shown by the Brave study to slow Alzheimers, it would be safer, less expensive, and more practical than a monoclonal antibody Rx. for Alzheimers.
This would all change if your prescription was for patented MND2119 and there were no generic MND2119s for Florida to substitute for your Doc's Rx.
It makes so much sense for Amarin's largest investor to have a place on the BOD.... I would not be surprised to see an immanent PR announcing that a decision has been made to do just that....and avoid an ugly and unnecessary proxy fight ...and I would not be surprised to see Dr. Denner then buy more stock than his present 24 million shares.
The Q3 C.C. showed that the present price of Amarin is much too low.
I would rather have Amarin drop Vascepa entirely and just market the patented MND-2119, plus a fixed dose combo with a statin plus MND-2119.
Amarin's responding to Nissen gives him more publicity, which he thrives on
Amarin's task is first and foremost to stop the reason for its failure, which is infringement by generic Vascepa in the U.S...Amarin needs to find a way to switch from Vascepa to MND-2119 both as a solo and as a combo drug...and then to support a marketing effort in the U.S. for them.
After that, Amarin can turn its attention to finding new indications such as Alzheimers, dry eyes, cancer etc.
In order to achieve these goals, a sale of Amarin to a BP is necessary...Otherwise, we are just spinning our wheels.
Brave is an invasive study (with serial spinal fluid taps)...If it were not trending in a positive direction, it would have been stopped by now.
I think that Nissen's continuation of the BS about MO had a lot to do with today's drop...but it points out how vulnerable Amarin is and how we need a change of course....I hope the BOD relents and gives Denner an opportunity to turn things around.
After the Q2 results the Amarin ship was feared to be sinking.....After the Q3 results, the fear is now gone and the Amarin ship is ready to sail...but the ship is still in need of power..and Denner can supply that power to navigate a successful trip....not only for investors, but for patients as well.
There were many good points that KM mentioned at the Q3 C.C. about Amarin's improved financial picture...
However, there were several things of interest that were not mentioned by KM...
-no mention of Denner
-no mention of MND-2119 as a solo drug or in a fixed dose combo with a statin
-no mention of the patented gelatin capsule of Vascepa as a preventative of oxidation of EPA.
-no mention of upcoming reports on the Respect and Mitigate studies - -no mention of the Brave study
- no mention of studies for other anti-inflammatory indications for Vascepa.
IMO some of these unmentioned issues would be better handled by a BP.
I agree...We've heard from KM...The market seems unimpressed...Now lets hear from Denner.
Nissen has a well established reputation for being an annoying person, who delights in provoking others by his criticism....He aims to preserve that reputation...If everyone ignores him, perhaps he'll disappear into the shadows..
Quote..."Research and development expenses for the three months ended September 30, 2022 were $5.8 million, compared to $7.8 million in the corresponding period of the prior year. This decrease was primarily driven by the implementation of our cost reduction plan announced in June and was partially offset by costs incurred related to the DEVELOPMENT of a fixed-dose combination of VASCEPA with a statin"
.This is GOOD NEWS!...Is MND-2119 also in the headlights?...So many opportunities...So little cash.
The V.A. is funding Brave to see whether Vascepa affords PRIMARY PREVENTION of AD in a population with a "PARENTAL HISTORY of AD"...Upon a successful completion of the Brave study in these Vets who are predisposed to to have AD(due to their parental history), the FDA will IMO give approval for Vascepa Rx for AD...on the condition that the study be continued...A BP can then buy Amarin and supply the necessary funds to continue the larger study at the University of Wisconsin.
I don't believe that Vascepa will be shown to cure Alzheimers...but I do believe that Vascepa may prevent it, delay it or mitigate it....If any one of these outcomes can be proven by a study, Vascepa would become a blockbuster drug from the treatment of that disease alone.
I am anticipating information on several important items at tomorrow's C.C, including an interest in Amarin's plans for MND-2119...e.g.. what dividends are due to Mochida for its use and does Amarin have plans to present MND-2119 to the FDA for approval and does it also have plans to include it in a fixed dose combo with a statin.
I would also appreciate hearing news about Amarin's response to Denner's proxy initiative.
The present main issue, IMO is not about the credentials of the new board members, but about whether this is the appropriate time for these appointments....and who, since this is a particularly contentious moment in time, should be appointing them to the board.
These appointments seem to be more in the interests of the present board than in the interests of investors....This is yet another example of the BOD putting its interests ahead of the interests of investors.
Nsleven...Your conclusion is logical
However, even though the MOA of V is unknown, there is now a consensus that the MOA is intimately related to the level of the serum EPA.
I hope the FDA would give consideration to this important difference between V and gV.
I agree...Denner has the experience and commitment and is in the best position to make good decisions as to the most favorable way forward for Amarin.
Nsleven...Dr Taub does comment that brand Vascepa produces higher blood serum EPA levels than gV...but she leave unanswered questions...
-i.e. Is this difference due to oxidization factors?
-If the difference between V and gV is due to factors concerning oxidization of the EPA in the capsule, is the time spent before use by the patient a factor?
-Is the difference due to an addititive in the gV that interferes with the absorption of the EPA?
I understand that Dr Preston Mason of the Brigham and Womens Hospital in Boston has been working on this issue for some time, but there have no been recent comments about his research by him or by Amarin.
"Amarin (AMRN) Appoints Craig B. Granowitz Chief Medical Officer And Names Steven Ketchum Chief Scientific Officer. Jan 22, 2016"
After the Du decision of March 2020, which indicated that Amarin would now be in a predicament going forwardh, both of these research "gurus" failed to do studies on Amarin's patented gelatin capsule to show that Amarin's capsule was necessary to produce the optimal effect of EPA drug delivery on the patient's serum EPA..
They also sat by quietly, while their partner Mochida lead the way to developing a superior drug delivery system for EPA (i.e. MND-2119)
very sysyem for EPA
PDude... My post was about my desire for such a study to be done...not a report of an actual study having been done...but I vigorously agree that such a study would be a great idea.
Pdude...QUOTE..."waiting for information comparing the efficacy of the patented gelatin capsule of Vascepa as opposed to the capsule of gV in producing an increase in serum EPA"
A study of patients treated with aged...or artificially aged gelatin capsules of Vascepa vs. regular capsules of gV... as to how the patented capsules of V were different from. the commonly used capsules of gV... in that the V produced a better increase in the serum EPA of patients than the gV.......This might be instructive....especially if the results were presented to the FDA....which now considers V and gV "equivalent"
Amarin's present predicament is mainly due to the invalidation of the Marine patent...If there is an opportunity to deal with this problem by marketing an improved fixed dose statin-EPA combo with Lipitor and MND-2119...every effort should be fully explored ASAP!...Reducing the requirement to take 4 EPA meds/day...plus one statin med/day(i.e. for a total of 5 CVD meds/day)...to ONE CVD med/day would help both in the areas convenience and compliance.
This is in addition to the antihypertensive and blood thinner meds that many CVD patients need to take daily.
Pdude...IMHO Denner, who has had loads of experience as an activist investor and has done a comprehensive analysis of the prospects for Amarin before and during the execution a total investment of over 100 million dollars in Amarin...is more qualified to make the decision as to if and when to sell Amarin than anyone on the present BOD.
Some of the issues that I will be interested on learning about at the Q3 C.C. on 10/27/22 include the details of the agreement between Amarin and Mochida in June of 2018...especially as they concern MND-2119.
Specifically....what, if any, royalties will be paid by Amarin to Mochida for products that the parties collaborated on(including MND2119) ?....and can the agreement be transferred to a new owner in case of a BO of Amarin?
If the terms of the deal allow Amarin to market MND-2119 profitably in the U.S., it could be a game changer.
Think of the current struggle, not as Amarin BOD vs. Denner...but as Olsen vs.. Denner...If Denner wins, Olsen loses face....Olsen may feel that even though he may eventually have to lose, he doesn't want it to appear that he was impotent...but that he put up the good fight..The fact that Amarin's other board members and Amarin's investors may also lose because of an extended fight is less important to Olsen.
Rose...You're correct..Sarissa invested in Amarin BEFORE Olson was appointed to the board by the then COB Ekman(who had just sold all the Amarin stock he controlled as the managing director of Serofinova hedge fund)....Then Denner continued to increase his holdings to 24 million shares...To my knowledge, there have been zero purchases of shares in the open market by any Amarin board members since Denner first started buying shares....Perhaps the price of Amarin would be higher than where it is now if they had had the confidence in Amarin to buy some shares as Denner did.
"By Eric Volkman – Nov 16, 2021 at 6:14PM
An activist investor revealed that it held a small stake in the company...
Shares of biotech Amarin (AMRN 2.75%) shot more than 3% higher on Tuesday. That was on the reveal that an activist investor has taken an equity stake in the business....
In a regulatory filing submitted after market hours on Monday, hedge fund Sarissa Capital Management revealed that as of Sept. 30, it held an 8.5 million share stake in Amarin. That represents roughly 2.1% of the biotech's current outstanding share count."
Now Olson is angling to keep Denner out so he can call the shots.
Denner purchased his first shares in Amarin in January of 2022...Olson joined the BOD of Amarin in the same month, (i.e. in January of 2022)...The difference between the two is that Denner has invested serious money in Amarin (over 100 million dollars)...Olson has hardly any investment in Amarin and could care less if Amarin goes to zero.
Caddie...The telling evidence in the PR, announcing the new board members, is not in what was said, but in what was not said...If these new board members were agreed upon by Denner and Olson, the two would have issued a joint PR announcing them....Instead, we will all hear about them at the Oct 27 Q3 C.C. from K.M., who will praise them, but had nothing to do with their selections and, who has been appointed by Olson to play the role of the fall guy.
Deja Vu....Nissen and Olsen...Nissen's pride was hurt when his baby, Omacron, failed...only to see Bhatt's baby, Vascepa, succeed....and he responded with malice
Now Olsen's pride has been hurt by Amarin's failure to make headway during his stint at the helm...and he'd rather not see Denner succeed....and he is responding with malice.
Rose...I agree....Olsen is just thumbing his nose at Denner...Denner is an affront to his pride...Olsen was appointed by Ekman, who had the decency to leave...Olsen is a wealthy man and has no concern for Amarin or its investors.
The long term investors like myself, who have been following Amarin for over a decade, understand that a sale of Amarin to a BP is now the preferred strategy...as opposed to GIA (which was the preferred strategy until judge Du changed everything)....The chairman of the BOD will make the final decision as to if and when Amarin gets sold to a BP...Denner would be the best COB to successfully oversee this strategy....In the meantime , Amarin needs to have management leaders, who not only have mergers and acquisitions experience, but also marketing experience in the the U.S and in the ROW.
Denner announced on October 11.2022 that he would initiate a proxy fight...Now...nine days later, Olsen announces several BOD changes...We will know shortly whether these moves by Olsen were intended to be constructive or obstructive.
If the appointments of the new board members were intended to be obstructive,we will know that these new board members were just being used as pawns...which would be insulting to them and to us...and disgraceful..
I agree...These seem like constructive changes...Now, if we could have Denner replacing Olsen, we might be finally heading in the right direction.
It would interesting to know the serum EPA in R-IT and in Respect at the start and at the conclusion of these studies...However, I am hypothesizing that the 4 grams of EPA in R-IT produced an equivalent serum EPA in the R-IT study population of meat eaters as in the 1.8 grams of EPA in the Respect population of fish eaters.
Serum EPA is an important test, but it is not done as commonly as it should be.
Prior to the release of the R-IT results, Dr Budoff said that in his opinion, there was an 85% chance of success from the study and no one(including W.S). believed him....?Any ideas as to why Respect would not be as successful as R-IT?