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Duke, I totally understand. We just approach it a bit differently. I'm very cautious, in some ways, by nature. I look under every rock. I try to find bad things that might trip me up. Be prepared and all of that.
Anyway, I have to look at every bit of information I can find and weigh it accordingly. Most of it is very good, but not every single little thing. And after weighing everything, because of all I see, I am invested up to my eyeballs in Amarin, and I do believe strongly in this drug, and that the company will do extremely well. But I have to do this weighing all of the evidence.
At the end of the day, I do believe as much in V as you as far as where we end up, but I just am not sure of the percentages. Anyway, of those that it works for, on those reviews, it seems to have really worked well.
I stand corrected there.
I get what you are saying. I'm not saying I am assuming these reviews are reflective of the general population. I know the sample size is ridiculously small, and there may very well have been self-selection (people do tend to post more about a bad experience), and there may be intentional bad-mouthing by competitors...
But, I'm also not completely willing to discount it to the point of believing without any doubt or hesitation that everyone will love it as much as this board does.
I used the words, have "had a bad experience" with it, not "hate it."
Here is one, but I'll try to find more:
https://www.drugs.com/comments/icosapent/vascepa.html
Fine, let me pull up the sites for you. You can read them for yourself and come to your own conclusion.
Granted, it's not scientific, but I've looked at some of the consumer review sites for V. If you can set me straight on those, I'd love to be proven wrong, since I am a true believer in spite of the reviews.
Maybe I should adjust those figures down some, because there were also some where it was more a problem of affordability.
Kiwi, I haven't been following this thread all of the way through, but I did see the beginning and the last few posts. Anyway, I agree with Iwfal to the extent I think a lot of the general public that has taken V has not had the striking results of many on this board. It seems like there is maybe a good 30% to 50% of people who are prescribed V that have a quite frankly bad experience with it, but then a high percentage also have a very good experience. I get the impression it is a drug many people either love or hate.
My two cents.
All of that being on a range, from most conservative, strict usage to most optimistic, relaxed usage and everywhere in between.
Maybe base it on the entire range. For example, I would imagine the conservative estimate might be more useful early on before there is wide acceptance and before people are comfortable with V. The more optimistic estimate might be more appropriate for estimates further off in time as people become more comfortable/less uptight and usage restrictions are relaxed. All of that is a function of how soon V gains acceptance based on advertising, word of mouth, education, etc.
Just a thought.
How about using both measures? One forecast for strictly on-label, and one that includes off-label usage? Or a range with conservative on one end and optimistic on the other end? Both would be helpful I think.
I don't fit the label unless CVD is very, very widely interpreted. My PCP laughed at me, in a good way, when I asked him about V, based on my health. But thanks for offering!
Maybe you can start writing prescriptions for everyone on this board! I'll be first in line. Just kidding. Don't want to scare you away.
There was a past post by LBL indicating fairly encouraging action by at least one insurer he knew of. And someone else mentioned the AHA was going to bat for Amarin to speed adoption of the new label by payers. Hoping this part of the expansion comes together fairly quickly.
FDA labeling guidelines. Sorry is posted before:
Thought these might be useful to analyze V's label and what we actually got and didn't get:
https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources
https://www.fda.gov/files/drugs/published/Indications-and-Usage-Section-of-Labeling-for-Human-Prescription-Drug-and-Biological-Products-%E2%80%94-Content-and-Format-Guidance-for-Industry.pdf
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/indications-and-usage-section-labeling-human-prescription-drug-and-biological-products-content-and
A lot of information to get lost in.
"Yes that’s a risk factor. Risk factors are left up to the prescribing physician."
******
Will the insurance company/third party provider have a say in this as well, regarding what is a risk factor?
For this as well as the definition of "established cardiovascular disease?"
And other parts of the label?
Brief NYTimes article - state of biotech acquisitions. From early 2019, but I believe it's still relevant: https://www.nytimes.com/2019/02/28/business/dealbook/pharmaceutical-biotech-acquisitions.html
Agreed. It's just a matter of time, sooner or later, as word spreads about V's efficacy, safety, cost effectiveness, and relative convenience. It's the perfect pill.
It's just a matter of getting the word out now.
Thanks, Bfost.
Is an LDL limit implied from usage as a statin adjunct?
Is "Established cardiovascular disease" actually broader than Reduce-It?
If broader, that is fantastic news IMO.
Welcome back, JL! Anyone have any idea when an announcement will be made?
"or perhaps JT will step down to allow for someone else to take AMRN to the next level.”
Agree with this analysis. If they do GIA, JT may not be the best CEO for that next step. I understand his background is not with BP but rather with companies in a similar position as Amarin. He has shown himself to be an excellent leader for Amarin as a relatively small drug company trying to launch a promising product, where cash flow and expense management while staying extremely focused on the priorities means everything. The financial side of running a business is his clear strength. No doubt he must be a strong leader in other areas too. But as far as I know, one thing he does not have is significant experience in BP, let alone running one of them. Not saying he couldn't become a great CEO on the next level, and he may need to go in that direction if the path is GIA, but I'm not convinced one way or the other.
Just speculation, but to the extent JT has taken on V as a personal mission, I believe he will feel his mission completed once he has label expansion and either has Amarin sold or on a clear path to success based on revenues. After that, he can rightfully take a lion's share of the credit, along with Dr. Bhatt, for leading the company that introduced V to the world.
But also, to the extent he and others truly believe V should be given to as many people as possible, for as many uses as appropriate, he and others may feel V would be best in the hands of a larger company with more resources.
Who on this board hasn't freaked out over this company's crazy price movements? I know I've had my moments. There's no shame in that. I believe it's safe to say most or all of us are in the same boat that way.
As many of us have said before, if we are invested for the long term, then short-term price movements don’t really matter much, whether due to manipulation or other reasons. What really matters is whether we believe in V and the company behind it.
JACC article on cardio drug development challenges
Thought this might be interesting to some on the board and something to perhaps give more perspective. Discusses pre- and post-FDA-approval challenges for cardiovascular drugs. Makes me even more impressed with what Amarin has done so far.
Gives some support to Bfost’s concerns over prescriber inertia. But, on the other hand, I realize some will say this is V we are talking about, where perhaps the normal rules will not apply?
"Overcoming Barriers to Development of Novel Therapies for Cardiovascular Disease
Insights From the Oncology Drug Development Experience"
http://basictranslational.onlinejacc.org/content/4/2/269
You're breaking my heart, JL.
I hope you'll at least be able to let us know how you are doing some time down the road. You'll need to let us thank you when we are truly over the rough spots.
Who in the heck is going to keep us all in line now?
Dancing, interesting breakdown. I look forward to the day when we are all having to worry about paying taxes on massive gains! Hoping and praying for that, anyway!
Tasty, good find, but I went back and checked and these are all orphan drugs that were fast-tracked. I'm not saying at all that V can't or won't get early approval before the PDUFA date, but I don't think we can infer anything from the early approval of the five drugs mentioned in the article since they are all orphan drugs and V is not an orphan drug. That difference matters since orphan drugs get very preferential treatment.
Here is one among countless articles that gives a good summary of orphan drugs and ways they benefit from that status, as well as a controversy that has been brewing over that status:
https://catalyst.nejm.org/time-reform-orphan-drug-act/
I wonder if these are all orphan drugs that got the early approvals? I ask because I understand orphan drugs on the accelerated track have all kinds of exceptions made that a non-orphan drug won't necessarily get. That could include approvals well ahead of the PDUFA date. So maybe this applies to Amarin? I don't know.
I believe the only reason why Amarin would go it alone is if BP does not offer an acceptable price for the company. I believe Amarin is ready to sell if it gets a good offer. I could easily see BP not offering enough as a result of either simply not being able to afford the price, or because BP gets too greedy and low-balls its offer.
Amarin won’t go for a low offer and doesn’t have to because it has enough money to do a post-label product expansion on its own. It's a great position to be in.
Like Couldbe, I’m thinking price may not be a huge obstacle, if, again, BP doesn’t get greedy and doesn’t insist on playing hardball with Amarin. I agree with Couldbe that a larger company can get much more out of V than Amarin can because Amarin is so much smaller. V has a limited patent life. That means that in the development and exploitation of V, speed is critical to unlocking V’s full value. A much larger company with a superior marketing program, sales force, R & D, legal, and financial resources will get so much more out of V. So let’s pretend a large pharmaceutical estimates it can get, just as an example, $3 million. And let’s say Amarin projects it can get $1.5 million out of V. In that case, the suitor would be willing to pay something less than $3 million. Amarin would generally be willing to accept something more than $1.5 million. Somewhere between 1.5 and 3 million is a lot of room to find a price both companies could agree upon.
The reason why there is so much room for compromise and room for a price both companies could live with is that V, as promising as it is with Amarin, is so much more valuable in the hands of one of the major pharmaceuticals. I guess that is the nature of a single drug with a limited patent life. So the incentive will be for Amarin to sell if it can find the right buyer, at an acceptable price. The greater value to be gained by a suitor would allow that suitor to offer a very attractive price compared to what Amarin could get on it’s own.
Beyond that example, there is at least one other reason for BP to value V more highly, not based purely on revenues. It is because, I think, many companies are looking for more drugs to fill their pipelines. V would be a great drug to get a company's R & D fired up again. If V were truly a blockbuster, it seems to me it could do a lot to reenergize a lot of companies. Amarin, I don't think, is looking to become the next big company. And so I don't think it places any value on V that way, and certainly not as a filler of existing, excess capacity.
Eventually, I do believe a buyout will occur, again, if BP is willing to offer a reasonable price. I believe the BO could happen very, very quickly if the price is right.
My two cents for the day.
Vu and everyone else, my apologies. When working (lunch time), no more commenting from me! I've tried it for just a month or so, and almost every time I end up not seeing the complete thread or not communicating everything I want to say because I have to hurry, and my message comes out a bit off.
In this case, I didn't see the full thread going back to the core issue about price movements.
That makes more sense to me, that a naturally-derived drug might not get as much respect from investors. I would imagine a purely man-made drug would have stronger intellectual property protection, among other perceived advantages.
Am I crazy to think BP is ultimately behind the price being held down? I keep thinking this is part of the "negotiations" going on behind the scenes. Just BP trying to minimize the price they will have to pay if there is a buyout. But can they have that much power over another company's share price?
Quote: “JMHO, but Amarin suffers in part from having a product that seems "too natural."
I'm on the other side of the fence on this one. I think the perception of V as a natural fish oil or fish oil derivative will make it very appealing to a large part of the population that is looking for a more integrated, holistic lifestyle. That includes more organics and less chemicals and processing in food, and less medical intervention.
Fish has such a great reputation. To me it makes sense to take advantage of that. I hope V will be seen as the ultimate fish oil supplement for those that are not wanting drugs per se. Of course I do think it's important to stress V's differences from non-V fish oil supplements, but not so much that V is portrayed as a just another chemically formulated drug.
I'm not saying drugs are a bad thing at all, but there are a lot of people that will be much more inclined to V if it isn't portrayed that way.
I would be surprised if Amarin corporate legal hasn't already discussed all of their options and heard about this, but maybe a call to Investor Relations wouldn't hurt?
They took on the FDA (hopefully no hard feelings). How hard could Oppenheimer be by comparison? Agreed it would be great to at least send a warning shot if a legitimate case could be made.
Are you all aware of "short and distort?" https://www.dlapiper.com/en/us/insights/publications/2018/10/sec-fires-warning-shot-against/
I had never heard of it myself, but here is an article for what it's worth. A lot more articles under "short and distort" in Google.
I would certainly be singing a lot more at $24.
But I always sleep well regardless. One of the few things I truly excel at.
Do the Evaporate interim results evidencing a MOA (the slowing of plaque progression), provide enough support for the FDA to justify a broader label? Drs. Bhatt and Budoff seemed to be arguing strongly for early intervention based on those results.