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Capt....Low cost beats high efficacy every time.
Robin...As long as Vascepa is profitable in the U.S....and there is no pricing agreement for EPA in China, I do not expect an AG for the U.S.
With the present Amarin policy of cost cutting, I expect Amarin to show some profits in the next quarters and this should help the stock price to start rising from its present lows.
Ekman and PWO, whom he recommended for COB, had zero interested in Amarin...KM was doing a good job, but he had no interest in a sale of Amarin, which would have meant he would have to give up his position as CEO...Denner was put in a position where he had no choice but to take the actions that he eventually was forced to take... after trying his best and failing to compromise with PWO.
Then, KM besmirched his reputation by threatening to sue Amarin for terminating his position as CEO, which he had voluntarily resigned....He did a relatively good job under adverse circumstances, but then, IMO, he embarrassed himself with this final ploy.
PDude..."The pharmacy is listing the approved uses of IPE."
The pharmacy is NOT listing the APPROVED use" of IPE....but an INFRINGING use!
Perhaps Amarin can direct its infringement suit against the pharmacy(chain) and/or the insurance company covering the IPE for the UNapproved and infringing use for CVD.
In my entire long life, I have not been sued or sued anyone...But this Dr Reddy infringement seems to me, as a layman, to be ripe for a suite...Where is Marjac when we need him!
Nsleven...re Tats suggestion of Dr Reddy attempting to invalidate the CVD patents in response to an Amarin suite against them for their obvious infringing on Amarin's CVD patents...Hikma did already try to invalidate Amarin's CVD patent at the time Judge Du invalidated the high triglyceride patent in 2020... (IMO a grievous mistake by judge DU, brought on by Covington incompetence and a Hikma fraud on the court)... and EVEN SHE decided the CVD patents were valid.
I would welcome a failed Dr Ready challenge of the Amarin CVD patent in an Amarin vs. Dr. Reddy infringement suite...to help the court determine what compensation should accrue to Amarin for the Dr Reddy infringement of the Amarin CVD patent.
Almost all of the well known cardiologists at the 2013 Adcom were NOT impressed by Jelis and INSISTED on completion of the R-IT study BEFORE they would approve Vascepa for CVD!
ramfan.."the insert describing what IPE is would not be considered infringement because they would claim it's just educational."
YES...It would be EDUCATING pharmacy chains and insurance companies to infringe on Amarin's CVD patent!
Capt...I assume that this explanation by Dr. Reddy of the benefits of Vascepa was cleared by their legal department...but I would still like to hear, in court, how Dr. Reddy attempts to explain how this statement is NOT an infringement on Amarin's CVD patent.
With small pharmas, the SP is largely
determined on prospects
for future revenues...
with large pharmas, the SP is largely
determined on prospects
for current revenues...
The market is sending Amarin a message
of no confidence for future revenues.
This explains why Amarin is currently undervalued and why it makes sense for Amarin to sell to a BP.
Amarin has current revenues...with prospects for future revenues from Europe and ROW(including China) plus a future AG and FDC for the U.S. and ROW.
Amarin could have named their epa drug Vascepa CV and avoided the high triglyceride hassle.
At the Goldman C.C., Berg, when asked about an FDC, mentioned that Amarin was "waiting for feedback from regulatory bodies".
This comment from Berg made me speculate about the following...
1. Amarin has already discussed an FDC with the FDA
2. The FDA has previously made the point, during the 2019 Adcom, that Vascepa can(or even should) be used in conjunction with a statin...so I see no reason why the FDA would balk at approving an FDC.
3. The main reason for Amarin holding back on a FDC now would be the cost to manufacture and market it.
4. The cost to consumers for an FDC could be little changed from the cost of Vascepa.
5. An FDC would not lower the market for Vascepa, but instead, it would advertise the notion to patients and Docs that Vascepa (or an FDC with Vascepa plus a statin) is effective for reducing CVD....and, as a result, stimulate the use of both
KIWI...About BCS Annual Conference
Monday 5 - Wednesday 7 June 2023
Manchester Central, Manchester, UK.
Theme: Future-proofing Cardiology for the next 10 years
rmb...Lasers were not in use for cataract surgery when I retired, so I will be speaking to your question as a layman...Lasers can help with corneal incisions and can help with incisions in the anterior capsule of the lens, which is then removed as a part of the surgery to remove a cataract...Neither of these methods were discussed with me by the surgeon in my case when I had recent successful cataract operations in both eyes at the Mass Eye and Ear Infirmary in Boston...in separate day care procedures two months apart...I had retina specialists standing by in case complications developed during surgery, requiring a vitrectomy, which thankfully didn't happen.
If you want further information about my cataract surgery, E-Mail me at..EFG0234@gmail. com.
KIWI...The difference between innovations in the corporate word and in the medical world is that profits in the corporate world are directly tied to these innovations...For Doctors, innovations help patients,, but they don't necessarily do much to help the Doc's income ...and Docs are always dealing with the fear of malpractice suits when they use a new method of treatment...even if that method has been proven scientifically to be effective...Most Docs want other Docs to lead the way in using a new treatment on patients....Once they see that happening, they jump on the band wagon...Then they have a fear of malpractice if they do not use it.
This happened with the introduction of phaco-emulsification of cataracts, which initially lead to many lawsuits, but which are now the standard procedure for cataract operations.
from the Goldman C.C.....When asked asked about an FDC..Berg replied..."that's still something that we're working on."
I'm afraid an FDC will have to wait for a BP that buys Amarin.
Denner is negotiating to sell Amarin to a BP...Discussing the details of his negotiations would be neither wise nor helpful....These negotiations always take time...There are some, who are unable to be patient... but for those , who can wait, I believe Amarin will sold at a much higher price than where it it is now.
Blame Judge Du or Covington or Kennedy for the present need to sell...But don't blame Denner.
IMO Neither Ekman nor PWO were interested in selling Amarin, but just milking it.
IMO the importance of ordinary board members is overrated...
The loyalties of board members are in the following descending order...
1. to the COB
2. to the other board members
3.to their own reputations
4.to their friends in business
5. to the shareholders
ORBAPU... on whether the BRAVE study is blinded...
An important part of the study is cognitive performance...
The study specifies" Time Frame: 18 months cognitive performance"
IMO the examiners for this part of the study would be difficult to be blinded...unless the cognitive evaluation were done by a series of questions to be given to patients for their written multiple choice answers...This would not be a very good study of patients' cognitive performance over the time period and I doubt this would be the chosen method for evaluation of cognitive performance.
The lab parts of the study could, however be blinded.
Nsleven...re the elongation of the Brave study..."Enrollment:150 [Anticipated] 131 [Actual]"
The sample size was reduced slightly, but the study was extended for 2 years.
Nsleven...re Brave study
"Primary Completion: "April 2021 [Anticipated] September 29, 2023 [Anticipated]
Study Completion: April 2021 [Anticipated] September 29, 2023 [Anticipated]"
The 'primary completion' date and the "study completion date' are now both both 'anticipated" to be September 29, 2023
My understanding of this change of dates means that this study was extended for over 2 years...Imho these scientists, who have dedicated themselves to finding solutions for Alzheimers, would not have extended the Brave study unless they were seeing some good results, but still waiting for statistical significance(which is unlikely to be achieved due to the small sample)...but, even without statistical significance, the FDA could approve a drug like Vascepa for AD, since it has a proven safety record... if it is case that the results are trending positive in a disease which has no really good alternative treatments.
Canes..."I've learned appeals are almost certainly a dead end. Although Marjac's was the strongest in my unprofessional opinion. I think it might have succeeded had Amarin been on board."
That decision was on PWO, who cared more about the interests of of Covington and Kennedy than about Amarin or Vascepa or patients.
When PWO sold all of Sofinnova's Amarin shares, he forfeited the right to be COB of Amarin....Denner's win in the proxy fight was a no-brainer.
I see no problem with Denner's team being awarded shares...Its when they start selling them. I get worried.
Capt...Thanks for the stats...Lipitor sells twice as much in the U.K. as all the other statins combined...It is an obvious choice for a FDC combo with EPA.
J.R....Don't your eye off the ball...Amarin is now for sale...and the best person to sell it is Denner....and the price will be higher than it is at present.
dogn..Thank you for posting this...The current Amarin web site can be difficult to navigate when you are looking to find a specific piece of news.
always..."Many bearish influencers have shown up lately."....Amarin is a low priced stock with relatively low volumes of shares changing hands each day....This makes Amarin an easy prey for those with a motive to pursue their desired result...Either on the buy side...or on the sell side....i.e. "talking your book"
We can learn from those "talking their book"...but should not be unduly influenced by them.
Tat...You forget that Denner's good reputation is the reason that he was able to take over Amarin...he's young and his reputation is worth a lot to him....This is not his last rodeo.
golf...Think of Amarin as a start up with lots of potential and us as venture capitalists...Amarin doesn't have to be "ripe" for us to cash out.
cbb..."Once pricing was determined in the world outside of the US, then the BP launches
a US branded generic"
Low prices for large volume purchases of EPA from wholesalers + low prices for large volume sales of a Vascepa authorized generic = significant profits for a BP and better health for patients....QED
Vaskepa can help reduce CVD in China.... As we know, smolking is a risk factor for CVD.
"There are more than 300 million smokers in China, nearly one-third of the world's total. More than half of adult men are current tobacco smokers. About one in every three cigarettes smoked in the world is smoked in China."
IMO Germany rejected Vaskepa because of the price....With the price lower...Germany will come around.
It would be interesting to see Vascepa being distributed to patients in China...and not in Germany, which is supposedly one of the world leaders in Scientific achievement.
Tat...Vaskepa is likely to be reimbursed in China, but probably at a lower price than the present price...It is in their patients' interest and in China's interest to have a reduction in CVD.
A...QUOTE.."On February 23, 2022, The Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication."
cbb...I agree that the milestone agreements could be amended, putting them off into the future...However, it is the idea of a newly increased volume of sales of Vascepa in China...along with royalty payments to Amarin, that is, IMO, even more deserving of attention.
cbb...Since Vascepa has a long history of being safe and effective for reduction of CVD in Europe, in the U.S., in Canada, and in ROW, approval for Vascepa for CVD in China should not take as long as did the China approval for the high triglyceride indication.
Amarin will be buying larger volumes of EPA and this will mean lower prices charged to Amarin by wholesalers.
Some details in the 2015 Amarin-Eddingpharm agreement ..."Terms of the agreement include up-front and milestone payments to Amarin of up to $169.0 million, including a non-refundable $15.0 million up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154.0 million. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens. Amarin will supply product to Eddingpharm under negotiated supply terms."
IMO this approval in China introduces a new era for Vascepa, in which Vascepa can be sold in volume...even if the price has to be somewhat lower than previously maintained.
Bob...QUOTE...“We are glad to receive this regulatory approval of VASCEPA from the NMPA China, and we are looking forward to securing reimbursement for this important product for patients and to a future CVRR indication approval,” said Rebecca Xu, Vice President of Clinical Development, EDDING."
THIS IS HUGE!...The next vital information we need is about reimbursement.
Amarin already up in pre-market!