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Got it, thanks. We need Denner on the Board ASAP.
Always good to hear from you! Why would the Bakers mostly bail if the biggest secret is coming (in 3 to 6 months)?
Larrybirdlegend--what do you make of Bakers' drastic reduction?
You were a big believer in them.
If the trial fails, where do you think stock tanks to? $1 per share $2 ? $3?
LBL--Any thoughts on Mochida's upcoming launch of once-daily Epadel as it pertains to Amarin? do you think the larger funds are aware....?
Great due diligence re: Mochida.
INDUSTRIAL APPLICABILITY
The self-emulsifying composition of the present invention is capable of providing a self-emulsifying composition which has at least one of excellent self-emulsifying property, dispersibility in the composition, emulsion stability, and absorption property, and in particular, oral absorption property and rate under fasting even though the composition contains no ethanol or has a low ethanol concentration by adding an emulsifier having an HLB of at least 10 to at least one member selected from .omega.3PUFA and homogenating the mixture. Also provided a drug of such self-emulsifying composition, its production method, and a method for its use.
The self-emulsifying composition of the present invention which can be more rapidly absorbed even in the case of oral administration under fasting compared to conventional compositions is expected to show preventive and therapeutic effects of the .omega.3PUFA. More specifically, the self-emulsifying composition of the present invention shows its effectiveness by the administration of 1 to 2 times a day at non-limited timing, namely, without the limitation of the administering three times a day immediately after the meal, and this convenience for the patients leads to the improved drug compliance, and hence, further improvement in the effectiveness. In addition, the self-emulsifying composition of the present invention can be combined with a drug which is administered not by the administration immediately after the meal, and also, a drug which is a combination with such drug may also be produced. Furthermore, the self-emulsifying composition of the present invention shows various clinical merits such as suppression of the serum TG increase after the meal by administering the composition before the meal and prevention of essential fatty acid deficiency associated with lipase inhibitor administration by administration of the composition before going to the bed.
Compared to the conventional emulsion preparation, the self-emulsifying composition of the present invention can be produced, delivered, and stored at reduced cost and with less trouble. In addition, the self-emulsifying composition of the present invention can be prepared water-free with higher concentration of the effective components, and hence, at reduced preparation volume, and this enables administration of the composition to patients with water intake restriction. Furthermore, the self-emulsifying composition of the present invention can be encapsulated in a gelatin capsule and the like, and this is expected to improve both drug convenience and drug compliance.
Due to the non-inclusion or reduced inclusion of the ethanol in the self-emulsifying composition of the present invention, this composition has reduced risk of capsule deformation and bubble entrapment by the ethanol volatilization during the capsulation step, and in particular, during the drying step, and also, reduced risk of capsule deformation and crack generation by the ethanol volatilization during the distribution and storage process. This composition also has reduced risk of the denaturing such as clouding and separation of the capsule content by the ethanol volatilization. Furthermore, side effects of the ethanol is absent or reduced in alcohol (ethanol) intolerant patients, and it is expected that the composition can be safely administered for a long period.
https://patents.justia.com/patent/10493052
From patent:
Advantageous Effects of Invention
By adding and dissolving an emulsifier having an HLB of at least 10 to at least one compound selected from the group consisting of .omega.3PUFA, its pharmaceutically acceptable salts and esters, the present invention is capable of providing a self-emulsifying composition which has at least one of excellent self-emulsifying property, dispersibility in the composition, emulsion stability, and absorption property, and in particular, oral absorption property and rate under fasting, and which contains no ethanol or has a low ethanol concentration, and which is capable of obviating the problems caused by the ethanol inclusion. The present invention also provides a drug of such self-emulsifying composition, its production method, and the method of its use.
Compared to conventional compositions, the self-emulsifying composition of the present invention which can be rapidly absorbed even in the case of oral administration under fasting is expected to show preventive, ameliorating, and therapeutic effects of the .omega.3PUFA for various diseases. More specifically, the self-emulsifying composition of the present invention shows its effectiveness by the administration of 1 to 3 times a day at non-limited timing, namely, without the limitation of the administering three times a day immediately after the meal, and this convenience for the patients leads to the improved drug compliance, and hence, further improvement in the effectiveness. In addition, the self-emulsifying composition of the present invention can be combined with a drug which is administered not by the administration immediately after the meal, and a drug which is a combination with such drug may also be produced. Furthermore, the self-emulsifying composition of the present invention is expected to show various clinical merits such as suppression of the serum TG increase after the meal by administering the composition before the meal and prevention of essential fatty acid deficiency associated with lipase inhibitor administration by administration of the composition before going to the bed.
Compared to the conventional emulsion preparation, the self-emulsifying composition of the present invention can be produced, delivered, and stored at reduced cost and with less trouble. In addition, the self-emulsifying composition of the present invention can be prepared water-free with higher concentration of the effective components, and hence, at reduced preparation volume, and this enables administration of the composition to patients with water intake restriction. Furthermore, the self-emulsifying composition of the present invention can be encapsulated in a gelatin capsule or the like, and this is expected to improve both drug convenience and drug compliance.
Due to the non-inclusion or reduced inclusion of the ethanol in the self-emulsifying composition of the present invention, this composition has reduced risk of capsule deformation and bubble entrapment by the ethanol volatilization during the capsulation step, and in particular, during the drying step, and also, reduced risk of quality change such as capsule deformation and crack generation by the ethanol volatilization during the distribution and storage process. This composition also has reduced risk of the denaturing such as clouding and separation of the capsule content by the ethanol volatilization. Furthermore, side effects of the ethanol are absent or reduced in alcohol (ethanol) intolerant patients, and it is expected that the composition can be safely administered for a long period.
Of the .omega.3PUFAs and pharmaceutically acceptable salts and esters thereof, EPA-E is known as a highly safe drug effective component. However, on rare occasion, EPA-E suffers from side effects such as vomiturition (0.21%), nausea (0.23%), and stomach discomfort (0.23%). The present invention is expected to enable decrease of the dose and/or frequency of the at least one compound selected from the group consisting of .omega.3PUFA and pharmaceutically acceptable salts and esters thereof, and the amelioration of the side effects leads to improvement in the drug compliance, and also, continuation of the therapy in the patients who would have been forced to terminate the administration due to the side effects.
In addition, an ameliorating or therapeutic drug for chronic diseases such as dyslipidemia basically needs continuous administration for a long period, and in the case of such administration, the present invention is expected to realize amelioration and treatment by reduced dose and frequency.
In advanced countries such as Japan, the U.S., and Europe, use of alternative medicine has increased, and examples include use of special purpose foods, functional health foods (designated health food and functional nutritional food), and health foods (supplements). The self-emulsifying composition containing at least one compound selected from the group consisting of .omega.3PUFA and pharmaceutically acceptable salts and esters thereof and an emulsifier having an HLB of at least 10 can be provided as a functional health food for human for those in need of the .omega.3PUFA, for example, those suffering from or those within the risk of suffering from dyslipidemia, peripheral circulatory insufficiency, and metabolic syndrome in order to prevent further occurrence of the cerebrovascular event or progress into ulcer and gangrene of extremities and peripheries to thereby maintain the quality of life.
So a new trade name in the marketplace and then as this trade name becomes more known with ads/marketing etc. it stands to be known as the CV drug....? New brand name. Patients start asking doctor about it....is that the thinking?
LBL---care to opine on MND-2119? Do you think the large funds have picked up on it?
Can you post where you read that again?
I searched the net and found this from Terrapharma:
(scroll down)🔍In addition to those two patents granted, partner Mochida has filed a patent application for "REDUCING NEW ONSET DIABETES" using icosapentaenoic acid and statin. 🔥🔥🔥 $AMRN #collaboration #partners pic.twitter.com/xXl3dxv3QN
— TerraPharma (@TerraPharma1) December 3, 2019
It's great to hear from you and hear that you are still holding.
Others had indicated that you sold out long time ago.
I guess the rumors have been greatly exaggerated.......
Captain sincere condolences to you and your family
Any guesses on who would manufacture / make bryostatin assuming the trial reads out successfully?
i think the two other failed trials have folks not convinced......we are in prove it mode now....
it's like how many times can you spin a failed study.
Welp at least I can wait till a month before Q4 to put more money here. LOL
It's a lottery ticket.
Anyone surprised we are not holding the gains? I thought we would have pushed through $7 based on the corporate update. When will this take off the last month before Q4?
Nevermind. Saw your post
Yes, I assumed it was Denner behind those changes. The majority of the BOD had not changed in 11 years and all of a sudden 3 directors were added. I'm fine with being wrong on that....but I know it was Denner who got AMRN moving on making some changes. Did AMRN select Denner's directors? Or did Denner want additional changes...(i.e., more Directors added). Time will tell. What I do know is it took an activist to come in for the BOD to start changing.
I have friends in the hedge fund world,.......I'm backing Denner 100%. Feel free to back management. Each person has to make his/her decision.
Good luck.
PS: Your post to me is exactly why I don't post as much anymore. Happy sleuthing.
You clearly are suspicious of Denner. You are free to hold your own beliefs....
I believe the rest of us are supporting him. He is here to maximize shareholder value....something the current management team seems to have had trouble doing post the ground breaking results of REDUCE-IT. But they have not had trouble awarding themselves more compensation. Go figure.
I am backing Denner.....he believes GIA is stupid as do I.
I'm glad he is on board and is doing what activists do.
btw: it is the second time you posted on this today. i wonder if you have another agenda....
I agree.
All my family members who own shares just voted ABSTAIN
Sarissa intends to vote Abstain at the annual meeting. It's getting interesting.....
https://www.businesswire.com/news/home/20220615006073/en/Sarissa-Capital-Intends-to-Vote-
What's the likelihood our new Chairman who has ties to Denmark also knows the folks at Noro Nordisk? Is he talking up Vascepa to them.......
https://www.reuters.com/article/us-corvidia-m-a-novo-nordisk/novo-nordisk-expands-into-cardiovascular-disease-with-725-million-deal-idUSKBN23I26M
Karim's comments during the presentation yesterday about other drugs it may make sense to combine Vascepa with.......
Whatever happened to Gilead's Nash trial? Weren't they using Vascepa? Obviously our new Chairman having been on the Board of Gilead would have been privy to those discussions....
I saw that Gilead and Noro Nordisk were collaborating on Nash. Interesting that Noro is a Danish company focused on metabolic diseases and our Chairman has Danish connections as well......I wonder if he knows those folks at Noro. Same country and in bio land.
https://www.fool.com/investing/2019/11/24/does-amarin-have-a-dark-horse-suitor.aspx
https://www.gilead.com/news-and-press/press-room/press-releases/2021/3/gilead-and-novo-nordisk-expand-nash-clinical-collaboration
https://www.reuters.com/article/us-corvidia-m-a-novo-nordisk/novo-nordisk-expands-into-cardiovascular-disease-with-725-million-deal-idUSKBN23I26M
https://www.novonordisk.com/disease-areas.html
You don't buy 6% of the company and not have influence on the Board. That's not how it works especially with activists. My friends work at hedge funds. The fact there was no proxy fight speaks volumes. Had there been a proxy fight it would indicate Amarin was not on board with where Denner wants to see this go: get sold.
Prior to Per joining the Board in January, the 7 directors had been on the Board for at least 7 years without any changes. Now all of a sudden you get a BP guy added in January who then becomes Chairman in May. Think about it.....the newcomer all of a sudden becomes Chairman on Board where there were no changes for the last 7 years. This doesn't strike me as a Board that likes to see newcomers hence the lack of them before. The Chairman of the Board sets the tone. It is a big position.
Denner got his Board seats without a proxy fight is a good thing. In the span of 5 months you have 3 new directors on a Board that had no changes during the last 7 years aside from the addition of Karim (CEO is always on the Board).
No No NO........keep shorting LOL
Stand firm. Do not let up.
My two cents on the BOD changes: this was all orchestrated by Denner. Denner wouldn't want to join the BOD in this case because as a Director you are subject to onerous restrictions on when you can buy//sell stock during the year. The Blackout periods make it tough.
The selection of Per Wold-Olsen as Chairman was also interesting. Makes me think Denner had him placed on the BOD earlier this year. So in essence Denner is controlling the BOD now. Lars gets demoted and that's a major demotion to go from Chairman to just a director now.
Now we know why the proxy was delayed. Denner did not have to go public with his request for BOD seats via a proxy fight. AMRN acquiesced like a baby.
If you're short AMRN going into any weekend now, you have to think long and hard about risk/reward. Recall that CNBC article that came out the weekend after Denner filed his 13-D where it said GIA would be a grave mistake. That too was orchestrated by Denner. That wasn't random. It was a direct message to the BOD.
Now we have Denner's picks on the BOD and his guy as Chairman.
Baker Brothers--no change in shares as of 3/31
Looks like BVF sold all as of 3/31 but they could have gotten back in when the stock hit the $1s....no telling to be honest.
https://whalewisdom.com/stock/amrn
Correct. Some may see a decline in a fund's ownership as of 3/31 as significant but such fund may have had advance notice that the first quarter was going to be bad. (private discussions with management....wink and nod)
So they sold prior and then share price just cratered as of late.....the risk / reward could have prodded them to get back in in the low $1s
3/31 filings just not as useful this go round.
I don't think these filings will be as relevant this go round. Will show what folks owned as of 3/31.
Funds could have sold prior to 3/31 then bought back in with the latest decline in AMRN's share price to scoop up shares.
We know Sarissa has to update if they buy or sell more than 1%.
As for the others, because the filings are so dated this time around.....not sure we can piece much from them. A lot has happened since 3/31 with AMRN.
https://www.cowen.com/insights/unlocking-value-from-the-inside/
He mentions a CV drug at the 30 min mark. I wonder which one he is referring too. Lol.
Sarissa’s average cost is $4.62.
If they increase or decrease their position by more than 1%, they have to file within 2 days. Had they gotten out, me thinks they would have sold asap as in wed to salvage any loss. No filing as of Friday.
Let’s get back to why they bought AMRN in the first place. It was not because of existing mgmt. Moreover, this past week’s decline likely further confirms their feeling this drug needs to be in the hands of a BP. Denner has a lot of contacts. Im sure he asked around prior to his initial purchases of what he thought AMRN could be worth to a suitor in addition to running his own DCF. Go back and listen to his podcast interview with Cowen. At the 30 minute mark he says he aims for at least a 2x on his investments for them to be worthwhile. The stock is in the $1s but BP is not buying this in the $4s. Denner’s average cost is in the $4s. Even at $10 this is still $4bn and change. Chump change for a BP and you get Amarin’s 10 year exclusivity in Europe and the USA mess is a free call option.
The drop this week while painful may be the blessing in disguise: accelerates this getting taken out by a BP.
Buffett always says be greedy when others are fearful and fearful when others are greedy. There is a lot of fear now. Conversely there was a lot of greed post the adcom approval.
Just my two cents.
Oh hi JT. Still taking trips to Nevada lol
If Denner is still holding after today and that is a big IF.....this drop may force management's hand to selling. Could end up being a blessing in disguise for shareholders to end this train wreck once and for all.
Management will be at serious risk of lawsuits and abdication of fiduciary duty even with a low ball BO offer. (It's the same thing Twitter management realized). BP has to be salivating at the decline today in AMRN.
We shall know soon if Denner is still on board.
Tell LarryBirdLegend we said hello. You are LBL right?
What a sh$t show! This management team & BOD should be ashamed for showing up.
I guess we will know soon if Denner bailed and cut his losses.
Thank God I had puts on my position.
The attention to scripts is comical at this point. They are not going to grow.
There is little to no USA advertising. The majority of Americans have no idea what Vascepa is.
Thankfully Denner alluded to in the interview he did if you have a CV drug and you are a BP it's just a matter of adding in another page / pamphlet to promote that drug. He knows what is needed here.
Still opportunities to make money tho.
Last week, I woke up and boom found out a company I owned was acquired: Sierra Oncology. Made for a great morning. A biotech at that. Acquired by GSK.
Will AMRN have its day....we shall see....
When do you expect the stock to start rising? end of Q3?
Surprised we are still at these levels.
Thanks. Omicron was surging but it was not as severe compared to other variants. Will be interesting to see of the control group if there was a huge increase in hospitalizations.
From the link you posted:
Outcomes and follow-up
The first of the co-primary endpoints is the incidence of moderate-to-severe confirmed viral URIs (ie, COVID-19, seasonal flu, and other known viral respiratory pathogens) based on laboratory testing leading to an urgent care appointment, emergency department (ED) visit, or hospitalization with an SpO2 ≤94% on room air (RA) and/or requiring any form of supplemental O2 (Table 3). There are 2 main PCR-based laboratory panels for viral URIs available at KPNC, a general respiratory viral panel (ie, COVID-19, Influenza A, Influenza B, and Respiratory Syncytial Virus) and an extended respiratory viral panel (ie, Influenza A, Influenza B, Respiratory Syncytial Virus , Parainfluenza, Enterovirus and/or Rhinovirus, Adenovirus, and Human Metapneumovirus). The second co-primary endpoint is the worst clinical status at any point in time during follow-up due to a laboratory-confirmed viral URI based on a 7-point ordinal scale (1?=?death, 2?=?mechanically ventilated/ Extracorporeal Membrane Oxygenation (ECMO), 3?=?high-flow supplemental O2, 4?=?low-flow supplemental O2, 5?=?hospitalized with no supplemental O2 requirements, 6?=?urgent care or ED visit not leading to hospitalization, and 7?=?no relevant clinical encounters) (Figure 3). Safety endpoints of interest include the incidence of new-onset atrial fibrillation, hospitalizations for atrial fibrillation, and bleeding events requiring hospitalization. Exploratory endpoints include all-cause death; major adverse cardiovascular event (MACE) (3-point) including death due to any cause, acute MI, or ischemic stroke; expanded MACE (5-point) including MACE, hospitalization for acute coronary syndrome (ACS), and coronary revascularization (ie, PCI and/or CABG), hospitalizations for worsening heart failure (HF); and the composite of hospitalizations and ED visits due to any cause.