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Oh okay, Mass. Not sure how much you know about it, but you might find it worth looking into more. Take care.
OT - stock tip
Hi all.
I know it has been quite a while since I last posted here. I have always appreciated you all, and I wanted to pass on to you a tip about a company you may have heard of, Celsion (CLSN).
The company reminds me of Amarin because it has a cancer product, Thermodox, that went through a drug trial which ended in almost total disaster for the company. But then, based on a review of a subgroup in that drug trial, the company decided to run another study. That study appears to be showing some promise in a sort of comeback, similar to Vascepa. In the past few days, the stock price has shot up about 60 percent.
The weird thing is, it has gotten almost no press coverage whatsoever, so it seems to be flying deep beneath the radar of a lot of investors as far as I can tell, but may be getting more attention soon due to some kind of independent interim review coming up in July, and because of the recent price action. I only happened to be aware of it because I had invested several years ago and then forgot about it, but it showed up on an old stock list of mine and I had decided to revisit it.
Anyway, if you are interested in it, please do your due diligence. I just started investing a few weeks ago. It seems to have a lot of potential and has already rewarded me well.
Cheers!
If I were an Amarin rep, I would be a lot happier with the FDA restrictions removed on what can be communicated to doctors, and with the new expanded label. I imagine it must make their job so much easier and much more enjoyable.
But I have been wondering if the regulatory approval of content Amarin is having to wait for is only required for direct-to-consumer ads, or if it also applies to other marketing materials such as posters and brochures and in-person visits by reps?
Does anyone know?
Will do, GG.
Irish, I'm hoping for V to catch fire eventually, maybe?
Here is an interesting read on the subject of catching fire if you haven't already heard of it, a book called "The Tipping Point: How Little Things can Make a Big Difference." I've only read parts of it myself. Just food for thought. It may be hoping for too much, but somehow it seems like something appropriate for V.
https://en.wikipedia.org/wiki/The_Tipping_Point
https://www.amazon.com/Tipping-Point-Little-Things-Difference-ebook/dp/B000OT8GD0
Mass, sorry I missed reading your rebuttal. Great response. That would be pretty cool if he replies back to you and it starts a conversation!
Irish, good point about reaching out through an Amarin rep if there is one that has already established a relationship. And perhaps have that rep make an introduction to Amarin people higher up?
I look forward to seeing the direct-to-consumer ads when they are approved and ready to be launched. Agreed it ultimately needs to be a concerted effort.
JL: "I think this doctor doesn't get it…”
Immediately below the article, the Philadelphia Inquirer says about the author:
"David Becker is a frequent Inquirer contributor and a board-certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown, Pa. He has been in practice for 25 years.”
In my opinion, it is precisely these social media and mainstream media influencers, like Dr. Becker, that the Amarin marketing department needs to identify and then try to educate with a phone call or other contact. Perhaps Dr. Becker wouldn’t be willing to listen or change his mind, but perhaps he might, especially if he cares about conveying the most accurate information to the public.
There are search tools, LexisNexis is the one I know of, which allow for comprehensive keyword searches of articles printed in all kinds of journals, newspapers, and other sources. I believe it should be fairly easy to identify who many of these influencers are in the cardiology and health care community through such tools and through articles found randomly such this one. Find these people who are quoted a number of times, who have the power of the pen.
Education is enormously important for V because there is already so much confusion about the benefits of eating fish and taking fish oil supplements, as we all know. But of course there is so much information to sort through nowadays, and not enough time. Because of that, I feel like those “experts” who aren’t intentionally trying to undermine V aren’t necessarily to blame if Amarin doesn’t at least try to reach out to them somehow to give them better information. It is these people who have the power to influence the general public and either add to the confusion or help to clear it up. Amarin needs to help them along.
Just my opinion.
Shinook, thanks for the post. Very encouraging news!
"it works for me."
I should restate that. It usually works for me. But not always. Some times it gets me in trouble. Anyway, it's what I am most comfortable with for myself.
Having said all of that, HDG, I do appreciate very much your sharing your thoughts and knowledge regarding the patent. It is helping me a lot to try to make sense of it all.
"ps.: Excuse me if I scared anybody with the facts and reality … I do not want to demolish any dreamworld ... but it is the real life ..."
Totally agree.
I think the willingness to challenge and test and probe can lead to a deeper faith in what I am examining. It allows me to develop a certain level of trust. It allows more credibility to be established in my own mind. I think it works better than no testing at all in terms of allowing me to embrace a thing at a level I am comfortable with, based on rigorous review. Sure I might question it during the examination, but if what I have examined withstands the scrutiny, I can then ultimately end up feeling even more confident about the thing than before.
But also, with knowledge of weaknesses and limitations, I have the ability to assess the risks and establish boundaries for myself. At least that is the idea, but I don't always do such a good job.
That process of forging strength and trust and figuring out what I know and don't know and how far I can go, through questioning and testing and adversity, is just something I am comfortable with. Maybe it is not for all people. But it works for me.
Thanks, HDG.
HDG, regarding "Carve-out ... legally is not possible"
First, thanks for your explanation of the overall situation.
You stated earlier: "Generics applied for full MARINE label (including treatment >12 weeks) they are not looking any „carve-out” of the MARINE label (which is – btw – legally is not possible, generic label has to be the same as - substantially similar to - Vascepa label prior December 13, 2019, aka MARINE label.)"
Could you please explain why a carve-out label is legally not possible and why the generic label has to be the same as the marine label?
What is the legal obstacle to a carve-out? Does it have anything to do with FDA approval? Any explanation would be appreciated.
Thanks again.
Merry Christmas and happy holidays everyone! Wishing peace and joy and comfort to each and every one of you.
Cheers!
"These Are The People Who Thought The iPhone Would Fail”
https://www.forbes.com/sites/bensin/2017/01/09/these-are-the-people-who-thought-the-iphone-would-fail/#13336a07544e
"Why the Apple phone will fail, and fail badly"
https://www.theregister.co.uk/2006/12/23/iphone_will_fail/
"WHY THE IPHONE WILL FAIL: Convergence Devices Have a Frequent History of Failure:
https://adage.com/article/al-ries/iphone-fail/117355
"8 Skeptical Early Reactions to Revolutionary Inventions”
https://www.mentalfloss.com/article/87288/8-skeptical-early-reactions-revolutionary-inventions
Not saying V is the next iPhone. Not saying V will be welcome with open arms right out of the gate. But just pointing out even the most successful of products and technologies have been met with resistance and skepticism.
Rose, interesting guess about the correlation of age with state-by-state obesity. I don't know the answer.
I did just read one of the most significant correlations with obesity is income/wealth. That seems to be borne out on the map. Just one more reminder poverty is so hard to overcome in so many ways.
Great link, Sharinky! Very encouraging! And it's good to see that it lines up with much of what this board has been thinking. Thanks!
Couldbe, the trends are really sad. I have to read up on Europe.
As we learn more about sugar and processed foods and educate others about them, hopefully we can start reversing obesity some.
I heard one new sport taking off among young people is pickle ball. I played for a while but stopped about two years ago. At that time, it was still just a sport for older people like me, while the younger ones were supposed to be doing things like basketball and soccer. But, I hear anyway, that is the wave of the future for all ages. .... Speaking of trends.
And yes, it's great we have V!
Wow!! Thirty marathons is impressive! I'm not a long distance runner myself. I could never run a marathon. I need a sport that involves running after a ball to motivate me.
Agreed, prayer, balance, harmony, and love for my enemies is part of a great prescription for a healthy life. I try anyway.
Here's to working knees and New Year's dieting resolutions!
Just another story on obesity trends, this one from CNN. Sad reality. I didn't realize it was quite this bad. Cites NEJM-published study.
"Half of America will be obese within 10 years, study says, unless we work together"
https://www.cnn.com/2019/12/18/health/american-obesity-trends-wellness/index.html
"Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity"
https://www.nejm.org/doi/full/10.1056/NEJMsa1909301?query=featured_home
And here's an interesting breakdown by state and ethnicity/race. It includes a useful map that highlights regional impact.
"U.S. Obesity Rates Reach Historic Highs – Racial, Ethnic, Gender and Geographic Disparities Continue to Persist"
https://www.tfah.org/report-details/stateofobesity2019/
Berryfit, I always pay attention to your posts because of your unique perspective on this board regarding diet and nutrition. Much appreciated.
It seems like there will be enormous pressure on the payers. The medical societies clearly want to put this in the hands of providers as a tool to treat CVD. Advocates of cost effective care have given their stamps of approval as well. The patient advocate at the FDA hearing called loudly and clearly for patients to be given access to the drug. I imagine that patient advocate is reflective of a lot of patients everywhere. Even the FDA seems on board having provided the flexible label. And all of this is happening amidst recent concern over the lack of breakthrough treatments in the area of CVD. And with aspirin losing some of its importance as well as stents.
Granted, I understand CV drugs can take a long time to be adopted, but how much better positioned could a drug be? If what we believe to be true is really the case, how much more pressure could there be on payers from the varied interest groups seemingly wanting this drug be made available?
Well congrats again. One prescription at a time. One doctor at a time.
Congrats, Trevor! Any particular reason for the change of mind by your doctor?
I suppose one other possibility among others down the road as they get bigger is a merger.
CBB, I hadn't thought about Amarin having to diversify at some point.
I think JT would prefer to sell too.
But if Amarin doesn't get an offer it thinks is high enough, then what other options does it have? Eventually, maybe the best option is to partner in Europe and elsewhere, to bring in cash. Maybe even partner in the U.S. JT certainly seem to be considering that possibility overseas. But it seems it's not the first choice. Many have mentioned if Amarin partners in Europe, they think it likely isn't as favorable a buyout target.
Off to work!
Could we as investors do better if Amarin does the GIA path even if that leads to V being “underdeveloped”? Could it not be argued we do better because we are 100% invested in a pure play on this superior drug even if the revenues aren’t as great? Or would we do better with Amarin bought out and V fully developed and exploited, and with us reinvesting our buyout profits in a BP that has V as just one of many drugs?
Which is a better situation to be in strictly from an investment standpoint if V becomes a blockbuster?
I believe that as things now stand, Amarin has to focus on getting ready to prime the pump with its marketing campaign and to get the revenues flowing and generate the profits and cash flow it needs to get the company into GIA growth mode. I believe I heard JT say Amarin is shooting for profitability instead of revenue. It would be yet another signal he is preparing for GIA if necessary, in the event a palatable buyout does not present itself near term.
I'm guessing BP is playing hardball and would love to buy, but not at the price Amarin is willing to accept.
I’m also guessing BP wants Amarin to fail in its expanded launch. If Amarin doesn’t fail, then BP will have to pay a much higher price if it wants V. If Amarin succeeds, and if BP really is insisting on playing hardball, perhaps the BO price become unaffordable. So I think there is a lot riding on the marketing campaign.
And I wouldn’t be surprised if the negative attacks continue and if BP is behind those attacks. I wouldn’t be surprised if BP is feeding negative reports to the main stream media. If this is the case, then Amarin is now involved in trench warfare and has to fight back to get its message out. If this is the case, among other things, I think it would be beneficial to develop champions for V in the main stream media offices. Perhaps get key health care media figures to promote the drug. I'm not sure. But it may not be enough to simply launch a traditional ad campaign.
I believe the timing of the marketing campaign is so key, because Amarin has to make sure the payers are willing to support V before the big DTC advertising campaign. It would be nice to see the advertising now, but if launched too soon, it could be a stumbling block if patients can’t afford what they are being asked to buy.
I believe that once again, we as investors are being asked to be patient and look at the long term. But if all goes well, we come out golden, either as a buyout target or on our own. As much as it hurts now, I believe we still have to ignore the short term price movements because they are not reflective of Amarin's true value as long term investors.
The battle is now in provider's offices, over the airwaves and in social media for the hearts and minds of the public, and for the support of third-party payers. Amarin has a great product with a strong label, the support of the medical community, and the cost effectiveness determinations it needed. It has the tools. It now just needs to execute and be wary of active opposition, in my opinion.
This is all just pure speculation on my part. For what it's worth.
Berryfit, thanks so much for the reply.
In my opinion, where you are, on the ground level of providing care, is what matters now. The battle has moved to the trenches. I hope you see a lot of movement and acceptance now that V has its label.
No lying this one hurt a lot. But I would much rather have what we got on Friday than anything else right now. The board comments and JT's comments leave me believing we got a label with substantial flexibility that puts important decisions in the hands of providers.
I am still taking the long-term view, and that view still looks fine. Somebody wants a fight. Bring it on. Amarin has been fighting with one hand tied behind its back, but now the ropes are off. And it has all of the right pieces in place including the backing of the medical societies and the cost effectiveness that insurers want to see. Most importantly, the simple fact is that people will pay for something that works and makes them healthier.
Thanks! hoping we can cut loose and celebrate some tomorrow!
Cheers, Kiwi!
Agreed, I've spent too much of people's time on this. Much appreciated all!
And V too!
No. Understand, I think Amarin is great, Biowreck. No confusion about that!
Kiwi, honest question. Am I reading the results wrong where it says adverse effects for V was 9 % for diarrhea and 5.4% for constipation? I'm not trying to pick a fight. Honestly I'm not. But seriously, I understand that, perhaps incorrectly, as the numbers that had those adverse effects, regardless of the placebo numbers.
Maybe I am. Maybe not. Believe what you want.
I come to this message board and put time into it precisely because people ask hard questions and the great majority doesn't just drink the Kool-aid. It's for everyone's benefit to be clear-eyed about this company. Me included. You too.
Agreed, Smarterer. That reminds me, I was wondering if maybe the population of reviewers, I think all with trigs over 500, would be more likely to have problems either due to V or for other reasons that they erroneously attributed to V. Perhaps that impacted the numbers as well?
Point taken. I was Christmas shopping on-line for a vacuum cleaner for my son yesterday. I agonized over the bad reviews on Amazon.com for that just about every vacuum cleaner sold. Even the Miele vacuum cleaner I was looking at couldn't get over 4 or 4.5 stars because of a lot of one-star reviews, and Miele puts out an excellent product. Anyway, I eventually came to the very conclusion you mention, that some of the reviews were likely hit jobs. And others were just unfortunate situations and unhappy people perhaps. So I had to just ignore those reviews and bought my son a Eureka Mighty Might, and I am sure he'll be quite happy with it.
Having said that, you bring up an interesting question. From the doctors on this board, and any others that might know, such as Berryfit, how many patients of yours have had a reason to drop V?
Fair enough, Orbapu. Much appreciated.
Thanks for suggesting it. It was extremely helpful to compare the chart to the reviews.
I don't get the complaints of joint pain, but I see a number of complaints about diarrhea and upset stomachs and (I think) peripheral edema???
So it kind of makes sense to me. And I think maybe what I am seeing too is the tendency of those with bad results to be more likely to post.
Again, I don't think it will impact V's overall success, but it does look like there are some people that just won't take it well. But as you all point out, the percentages on these reviews are likely inflated.
JJPOW, I did read it several times. That's why I'm invested in it!
Most Frequent Treatment-Emergent Adverse Events: ≥5% in Either TreatmentGroup and Significantly Different
Preferred Term VASCEPA (N=4089) Placebo (N=4090) P-value
Diarrhea 367 (9.0%) 453 (11.1%) 0.002
Peripheral edema 267 (6.5%) 203 (5.0%) 0.002
Constipation 221 (5.4%) 149 (3.6%) <0.001
Atrial fibrillation 215 (5.3%) 159 (3.9%) 0.003
Anemia 191 (4.7%) 236 (5.8%) 0.03