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A silver lining behind all of this is that it seems pretty certain that the stock is being manipulated by outside forces. Still not sure who all of the players are, of course. Before I was operating under the assumption that the price movements were normal, though I had suspicions. I thought maybe I was just being paranoid.
So I feel pretty certain they have come out of the shadows.
That knowledge has to be worth something. For example, in the future, I'm not necessarily going to buy on good news. In fact I may consider selling a portion in expectation of more hatchet jobs like this one, so I can benefit on the downside.
And I'll have more resolve on the downside. I will be buying as soon as I can to take advantage of this latest move down.
Knowledge is power. We now, I think, know more about the opposition, including that there really is one, willing to go beyond arguing facts and willing to distort the truth.
This is a real fight.
If the goal was to manipulate Amarin and it's share price, this isn't subtle at all. Kind of like the Citi report, but even more blunt. It's just too far out there to be a serious report.
If the goal was simply to take attention away from the Adcom and Evaporate results, maybe it worked. Time will tell.
Sonam, thanks for your reply! It's a great overview and greatly appreciated!
So it's good to know the sourcing for EPA is not a big concern at this time.
Once the announcement about the expanded label comes out, it will be interesting to compare estimated sales forecasts to the refining capacity forecasts. I guess we can cross that bridge when we get to it.
In the meantime, it seems there will be lots of craziness. Hoping all of this just means that a lot of people out there think Vascepa is an important drug worth fighting over.
Sonam, thanks for setting me straight.
But I'm so disappointed to hear carp are not a viable source. What is your opinion about the sustainability of the omega oil supply in the near term and beyond? I have seen some of your postings, but I haven't been on this board long enough to know your overall view.
Off to work.
Thanks again.
By the way, Asian Carp is extremely popular in Asia and I believe some parts of Europe. The Chinese have been farming it since around 3500 BC.
Fish oil supplies: good trade industry summary
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I think this article is worth a read as it gives a good overview of where the world's Omega 3 comes from, including a brief reference to algae:
https://www.iffo.net/industry-news/industry-news-2
Figure 3. shows Cyprinids (I believe mostly Asian carp) provide the lions share of Omega 3 oils (I think that may include fish meal). Farmed fish will soon be a net provider if it isn't already.
The article is from this trade group website, IFFO:
https://www.iffo.net/representing-and-promoting-fishmeal-and-fish-oil
I'm sorry. I looked at a map and
my speculation doesn't seem to apply everywhere. Enough from me!
Mass, I wonder how Japan compares to countries with comparable life expectancies?
It appears the dementia by country correlates with life expectancy? Except for Singapore. It seems the longer the life expectancy, the greater the dementia. I'm guessing dementia shows later on in life, so if you die of other things first in a less healthy/affluent/ politically stable country, that's why dementia rates are lower.
I's shocked that Russia is 110th in the world. Too much vodka maybe?
Georgia Life expectancy = 66.5 Ranked 82nd in the world
Cambodia = 68.7, 123rd
Inda = 68.3 and 125th
Singapore = 83.1, 3rd
Canada = 82.2, 12th
Iceland = 82.7, 6th
Sweden = 82.4, 9th
Switzerland = 83.4, 2nd
Norway = 81.8, 15th
Japan = 83.7, 1st
Pulled from Wikipedia. https://en.wikipedia.org/wiki/List_of_countries_by_life_expectancy
"You shoulda called me sooner..Better late than never!"
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Absolutely! Life is so much better. No regrets. Lesson learned!
For a number of years, I had a kind of burning sensation and pain and weakness in my arms. Had it especially when I lifted decently-sized items or used a bit of force to do things like scrub table tops with a sponge. I couldn't quite tell what is was. And playing racquet sports aggravated it. My doctor thought it was tendonitis or something like that the one time I saw her about it, because of the sports. But then even when I took a break from sports for a while, I still had the pain and weakness. I thought it was just me getting older so I just accepted it.
Eventually I got old enough to get a physical and a blood test. My vitamin D was very low. So I began taking vitamin D supplements at the doctor's orders, and the pain and other symptoms completely disappeared. I have to think the vitamin D deficiency was the cause all of those years.
Thanks for the great explanation.
Going down a different trail, that makes me wonder what happens from the individual consumer's perspective. When the pharmacy runs out and is waiting for the next shipment, do they give preference to their existing customers and turn down new customers? I wonder how they ration or prioritize generally.
Thanks again.
I honestly don't know anything about how prices between drug companies and third party payers are determined, nor how that impacts the price to the consumer. Agree with you all that if Amarin can negotiate a better price for themselves without changing the final price to the consumer, then why not do it. It would be crazy not to, right?
I was thinking the same thing, that it may all become irrelevant as an issue for Amarin if/when it gets bought out.
Maybe I'm overstating my case. I could see prices rising to meet whatever the ceiling is that is set by cost-effectiveness determinations. But I'm still leaning towards thinking they keep prices low. Wishful thinking maybe. Just my two cents.
Just my opinion, but I think a product shortage is more of a concern than price increases.
I'd be very surprised if Amarin doesn't already have contracts in place with their suppliers/manufacturers so that the price between them is set. So price increases being passed on to them which they have to in turn pass on to the consumer doesn't seem likely to me.
And here is Amarin's Q and A on fish supplies:
https://amarincorp.gcs-web.com/static-files/415bd347-0579-4897-bec9-a0e82d4f0380
Furthermore, there are contracts with insurers and cost effectiveness concerns of the public that have to be kept in mind. I think it would be bad press for the company to raise prices more than a nominal amount. Who knows what the insurers will pay.
Also, increasing prices won't have much impact on demand. The demand will be there regardless of price. I don't believe increasing prices will be a way to keep supply from running out.
Maybe I am naive (I often am), but JT and the company strike me as not the kind to increase prices unless they absolutely have to, because they really believe in their product as something good for everyone and they believe in V as a mission, not just a product. But maybe that goes out the window if they decide to go it alone and need revenue. But I don't think that will happen.
If supplies were to run low, with prescription drugs, is it first come first served? Has any company ever flat out just run out of a drug?
The worst case scenario which I don't expect is the Popeye's chicken sandwiches scenario. Hope Amarin is better than that.
That would be nice, but I wasn't thinking that broadly, to other diseases.
I was thinking more along the lines of expanding the label to subgroups or populations in Reduce-it where benefit could be seen, but not with the level of statistical significance usually required, because they were not the main focus of the study. I'm mostly trying to gain insight into how much the FDA is willing to make those exceptions.
Cbb, that would be great news!
Hopefully as they continue to analyze the data, they can continue to narrow down the cause of the bleeding. If the bleeding is due to aspirin... V would be just that much more incredible.
Thanks!
Found an article that might give some insight into the FDA's attitude towards V's label. The article may not apply to V and instead be limited to the FDA's stance towards more difficult to treat diseases and orphan drugs. Not certain. But in the very least, it shows a willingness by the FDA to make exceptions in some cases. Here is the most interesting paragraph:
"The FDA’s more flexible stance towards drug development in recent years has resulted in some drugs for orphan diseases being approved for use beyond what was studied in clinical trials. During the SVB Leerink event, Woodcock said the agency is open to doing that if it’s clear the therapy’s mechanism of action could benefit a wider group of patients."
Here is the full article:
https://www.fiercepharma.com/pharma/fda-promises-elevated-new-drug-approvals-but-warns-potential-pitfalls-report
Question: If bleeding or Afib were a significant concern, wouldn't that have already shown up in existing users of V? Isn't there already a safety record in the current V patient population? I suppose it's partly a matter of actually getting reliable data together, but is that doable? Could a survey be taken of current prescribers of the drug to see what their observations have been? Or just the experiences of individual users, like people on this board?
Great news, Bfost! The AHA going to bat for V is pretty amazing. Wow.
Thanks Study. Between your insights and everyone else's, especially regarding the mood of the room, I've learned so much. Priceless information.
Long-term solution. Think long-term.
Concern with a lot of fish is over long-term sustainability.
Research Asian carp. That may be a big source of fish i in the future including for Omega 3.
Any chance the FDA called the Adcom to give people a chance to try to poke holes in the study and raise any concerns the FDA hadn't thought of? I didn't get a chance to see the video, let alone attend in person, so I have no idea myself. But if basically no one was able to make a convincing case against the drug or find legitimate weaknesses, that's pretty encouraging. Because then it sounds like more a green light to give V a broader label.
That's right. It was a good day today regardless of the short-term price movement tomorrow.
I kind of like that the market was closed today for the stock, so I wasn't blinded by how much money I made or lost. I can just appreciate the day for what it was. Not saying the game is over by any means. But just to me it was a good day.
Berry, your point of view is interesting. One thing I really like about this pill is that I think it will come to be seen as both a drug and not a drug (an excellent anti-drug) since it comes from a very healthy, natural food source. It seems to me that if V is marketed the right way and gets a good label, there is a good chance the holistic health community will embrace it with open arms.
Congrats everyone! What a day!
So in the remaining ten percent, are there any subgroupings large enough to draw statistically significant or fairly reliable conclusions on effectiveness below 150? Is that one of the issues?
Vu, I admit I did think about adding some when the price was below 14, but like many others, I was already overexposed.
Good to know you were able to take advantage of your own advice!
Props to Vu. When adcom first announced, I seem to remember Vu reiterating over and over his belief MO was not an issue to Adcom and it was instead about label expansion. Not to take away from all of the other great opinions, but that really helped me try to make sense of what was going on during that crazy time. Still a ways to go....
Thanks, BB. I have no idea if the FDA is truly concerned or not. Sounds like you and JL and others believe it's so much of a nonfactor that if there is any benefit to V at all, FDA will likely not have a problem with adverse effects. So then it would just be an issue with proving effectiveness to the FDA at that point. They do consider cost not only in adverse effects but also whether justifies society spending the money, so effectiveness still a real issue.
Much appreciated.
Forgive me if this has already been asked and answered, but from a medical standpoint, I wonder what steps can be taken to monitor and counter the risks of bleeding and Afib. Is this something that can be answered with the information obtained from the study and current medical knowledge of these risks?
Off to work again.
Thanks everyone for your amazing discussions on everything related to V and beyond.
Good suggestion. I haven't heard anything either.
Thanks, Vu. No sense in rehashing all of that if it's already been discussed!
Interesting point. So that kind of begs the question, just how extensive is the use of MO in lipid trials? If its use is widespread, then why pick now to question its use? And if they discourage its use here, then they'll have to discourage its use in other trials. Or at least account for its potential impact in all other studies as well.
Which leads to another question, whether there are any alternatives that work any better.
I'm just really asking whether it is practical or realistic to question MO as a placebo. One would think this question would have been settled a long time ago unless MO isn't used all that often?
Louiie, it must be tough to be in law enforcement these days. Thanks for your service.
If that is the case, then it sounds to me like JT simply hadn't gotten around to talking to Dr. Bhatt about it, as opposed to JT asking Dr. Bhatt and Dr. Bhatt saying "maybe" or "I'll try."
I'm sure they'll do what they think is best. But I can't imagine Dr. Bhatt not wanting to be there in person after investing so much of himself into this trial.
LBL, I like your optimism. I can't necessarily r-e-l-a-x, but, your post has
r-e-d-u-c-e-d m-y n-e-r-v-o-u-s-n-e-s-s.
Thanks!
Makes sense, onerag. Glad we have Dr. Bhatt and company for the scientific discussion. Makes me think the clearer and more overwhelming the evidence, the better. And maybe it will be enough to put the MO issue to rest. Put it under the category, what doesn't kill us makes us stronger.