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Re. #7.
The way the unconscious mind works, the reader may retain only 2 items: “Significant” and “MO”.
eg., “The mineral oil placebo was approved by the FDA and a review of the literature affirms it as a neutral bystander.
“Single payer would kill millions...”
Yeah, us Medicare folk are dying off in droves due to our single payer insurance. Sad!
And then there’s this:
https://www.marketwatch.com/story/obamacare-helped-make-a-50-dent-in-personal-bankruptcies-2017-05-03
Thanks. I’m in good health too. Some of it is genetic but a non-inflammatory diet and active lifestyle also likely helps. I have next of kin with CVD history. Although not on statins, I take 100 mg of CoQ-10 for mitochondrial health.
I believe pneumonia was lower in the Vascepa group.
http://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_502890.pdf
Agree, (I don’t either) but:
- Makes the point Vascepa is not fish oil.
- Shows Vascepa has complex formulation such as one might expect in a powerful drug.
- Suggests Vascepa can’t easily be counterfeited in a Chinese lab.
Vascepa is not fish oil, purified or otherwise. Vascepa is Icosapent Ethyl, a derivative of the chemical molecule Eicosapentanoic Acid (EPA), one of the omega 3 polyunsaturated fatty acids. EPA is found in fish oil, algae, and certain plants. More technically, Icosapent Ethyl is a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol....Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine. It reaches peak plasma concentration in 5 hours post-oral administration. Very little (<1%) is left circulating in the plasma as EPA incorporates into phospholipids, TG's, and cholesteryl esters. Vascepa is 96% or higher purity Icosapent Ethyl.
Or, as one of my old bosses used to say: “An error of the third kind”.
Ah yes, the BOB’s (Buy Out Boys) are at it again, opining how BP can save their timely, well deserved fortunes from this, “who the hell do they think they are”, pipsqueak company.
BP paradigm: Many drugs , one disease.
Amarin paradigm; One drug, many diseases.
People who work in manufacturing will understand the enormous significance of this.
Economy of scale is a key ingredient for competitive edge. Taken to the extreme, the cost to produce a product will approach the cost of the raw material as production quantity increases. Every time a new product is launched, it is front loaded with the nonrecurring cost for research, design, development, certification/qualification, and manufacturing lines, etc. Those costs have to be recovered on future sales margins. Those margins, in addition, have to cover profits to the owners and perhaps advanced development for the next generation product as well.
As you can see, all Amarin has to pay for in terms of recurring cost are trials for new diseases! Then, the more Vascepa produced to treat more diseases, the less expensive it becomes due to economies of scale. Moreover, all the nonrecurring cost to expand production is paid by their suppliers.
A master stroke if I ever saw one!
Chronic disease is the self propagating golden goose of Pharma. The drugs are expensive. The disease is never cured. The drugs cause dangerous side effects that must be treated with more drugs, also expensive and with their own side effects. Patients’ lives are extended so they can continue buying the drugs longer. What a deal!
My belief is that BP would focus on the RI cohort and bury Vascepa for other indications. Why would they threaten their existing expensive drugs with a cheaper alternative? No corporation is in business for the betterment of mankind, including Amarin. Amarin can make the maximum amount of money treating as many diseases as possible with Vascepa. Best part is that it doesn’t threaten the statin business at the moment.
The idea that big is always better belies the facts. Big makes a bigger splat when it collapses. SpaceX is outdoing Boeing and Lockheed in the commercial rocket business. Any hapless BA or LM employee unfortunate enough to have suggested landing boosters after launch would have been laughed out of the room and sent to sit with the interns.
You’ve eviscerated FDA so many times they must be completely gutless by now.
I for one have been busy supersizing my dreams.
Quote: “R-I interestingly did have a single fatal bleeding episode in the placebo or active arms..”
I assume you meant did “not”.
Looks to me like the Nobel prize has already been awarded.
https://www.nobelprize.org/prizes/medicine/1982/summary/
Well, I just did a test on my new iPad Pro and it does respond to tongue touch (TT). I’m pretty sure JL uses a keyboard though so the dentist would have needed to take his fingers as well. Any such attempt likely would have left a toothless dentist. Odd that a sharp tongued person such as yourself is so defenseless when faced with a sharp tongued rival. Buck up buddy. You’re swimming with the sharks here.
Triple throw down Amen!
Agree that MO is not an issue, at least in my opinion for whatever that’s worth. I think it is a very good thing Vascepa is aligned with and not competing with statins at this time.
Collins is a strong statin advocate if you want to do some research. There’s been some controversy. Vascepa doesn’t, in his mind at the moment apparently threaten statins.
August 7, 2015 ruling
http://hr.cch.com/hld/AmarinPharmavFDA.pdf
Item 1 of the order seems general.
Item 2 is specific to doctors
Both items 1 & 2 seem specific to high triglycerides
Item 3 is specific to doctors
Item 4 ?
Not sure who posted but here are a couple references that may help.
http://static.coreapps.net/goed2018/documents/6b56eccfb3c187f0419ee4e716973cb1.pdf
https://jamanetwork.com/journals/jama/fullarticle/198183
Near as I can tell every successful business can trace it's origins to the inventors, visionaries, and yes, business people. Conversely, I can't think of any failed, bankrupt business whose failure can't be traced to the solely to the businesses people.
I know. Can't for the life of me figure out why AZN is pursuing this. Especially in light of likely raising LDL-C.
From your post:
"I hope the STRENGTH trial is a success because it will just add more weight and validity to the prescription grade fish oil paradigm shift in the mind of the AHA, who ultimately determine the standard of practice guidelines. 2 successful outcomes trials holds more weight than just 1 with R-IT vs the slew of all the other failed fish oil studies potentially including Epanova."
I think failure is the better outcome. Epanova is a triglyceride form of omega 3 and similar amounts of EPA and DHA as one finds in a DS. Like DS, I believe epanova is classified as a nutraceutical product and I'm not sure that Vascepa is. Epanova contains 550 mg EPA and 200 mg DHA per 1 gram capsule. For comparison, Dr Sears OmegaRx 2, also triglyceride form, contains 500 mg EPA and 250 mg DHA per 1 gram capsule. That seems to put Epanova at much higher risk of DS competition. If STRENGTH is too successful, then Vascepa is more vulnerable as well.
Vascepa is not fish oil, purified or otherwise. Vascepa is Icosapent Ethyl, a derivative of the chemical molecule Eicosapentanoic Acid (EPA), one of the omega 3 polyunsaturated fatty acids. EPA is found in fish oil, algae, and certain plants. More technically, Icosapent Ethyl is a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol....Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine. It reaches peak plasma concentration in 5 hours post-oral administration. Very little (<1%) is left circulating in the plasma as EPA incorporates into phospholipids, TG's, and cholesteryl esters. Vascepa is 96% or higher purity Icosapent Ethyl.
AZT will have resources to heavily market the drug. I could see them using their trig formulation to claim their product is natural compared to Amarin's chemically concocted unnatural product.
So is Dr. Evil and his sidekick back at his lair working night and day to stage a repeat performance with Vascepa?
In my opinion Dr. Nissen’s comments after the REDUCE-IT results were released were unprofessional. A class act would have respectfully declined to comment because of his involvement with another omega 3 heart trial. Then he would have congratulated the Amarin team on their success and stated he was looking forward to upcoming results of the STRENGTH trial.
This was an ethics violation IMO and while he’ll likely not face formal consequences, I think it will set him apart with his professional peers as a hack. His reputation won’t be enhanced if his trial results don’t pan out.
He’s done this type of thing before. Dr. Nissen was interviewed and appears in the Netflix documentary, “The Widowmaker”. Quite the performance! Below is a quote from the review by cardiologist Michael Accad, MD on a website called alertandoriented.com:
“A memorable one-liner is given by Steve Nissen, former president of the American College of Cardiology. Nissen, who opposed the heart scan, confidently tells the interviewer “I don’t like medical cults,” and proceeds to crack his knuckles, seemingly doing his best to impersonate Austin Powers’ Dr. Evil.”
Near as I can tell from AHA 18, the Cult of CAC is still around.
What a contrast to Dr. Bhatt’s world class performance leadership and reporting of REDUCE-IT!
Try to get sobered up. Your family will be grateful.
Usually afternoons because I like the sun and warmth. Not far, 3.5 miles or so. Just got back from Hawaii. Didn't run as much as I should have but memorable. Live in Illinois so have a treadmill for this time of year. Son who lived in Minneapolis until this summer would go out @ -10 F! I'm crazy but not that crazy. Thing is, when things get in the way & I don't run for 3 weeks, i don't feel out of shape at all.
Exactly. Makes it a lot more pleasant too. Come back from a run and not really that tired. Haven't tracked it, but peak heart rate seems lower. I'm 67 so I appreciate the benefits a lot.
Note: re hamstring vs. quads, meant: "not" fighting each other.
Similar experience. Easier to move, less stiffness the next day even after not running for awhile. I also do some yoga that includes intense, lengthy (5 min +) quad and hamstring stretches. Less energy expended with these guys fighting each other.
Regarding the idea that another trial is needed to retire the MO "issue ". I posted something along this line recently...
That's like admitting to a crime you didn't' commit and then hoping the Innocence Project comes to the rescue and overturns your sentence.
The board is losing its mojo and needs to regrow a pair. We are dealing with the big boys now and they take no prisoners. Where do you think those billions of dollars in savings are going to come from anyway? Well, I'll tell you. It's going to come out of the hungry (greedy?) mouths of big pharma, interventional cardiology, device makers, and medical industry generally. Go a little deeper and it's not going to be good for EMT's and funeral parlors either. Pretty much everybody except patients, Amarin and its supply chain, and steely eyed investors stand to loose.
If you want to console yourselves, spend some time imagining if instead of a nonissue like MO it had instead been a bleeding issue. Statistical significance, even one fatality, a hemorrhagic stroke, or a gastro bleed would have in my opinion been much harder to deal with. Pennywise the clown must be passed out on the couch tonight after drinking an extra bottle of wine in celebration of sawing the board in half with a plastic straw.
As someone who retired from a big cap multinational company and involved in due diligence work, you are absolutely correct. M&A expectations and beliefs of posters here and StockTwits are uninformed and naive. There is a small core group and SME's as needed. It is secret. There is a process and it is followed. They have sophisticated, evolved models and every imaginable scenario is run. It doesn't go to the board until the deal makes sense and can be explained.
Maybe not a good idea to post when you’re drinking.
Folks were surprised and incensed by the stunt taking the stock down the past few days. Other companies get the same and worse treatment as reported in this article. Hope the spotlight on Amarin fades soon, but with the massive amount of money at stake we can be sure evil forces are looking for any weakness to exploit. I'm keeping my guard up.
https://www.marketwatch.com/story/uk-defense-contractor-babcock-targets-secretive-vigilante-research-firm-2018-11-14
Seems to me like pleading guilty to a crime you didn't commit and then waiting 20 years for the Innocence Project to overturn your sentence.
Agree. Been seeing this stuff for years. Should have written "so called" law firms.
Homework for our continuing high intensity education at the College of Ignorance + Exuberance = Go Broke Investing: don't be too surprised if more law firms pile in tomorrow and maybe more bad actors.
Totally of the same mind.
I’m some surprised but not shocked. Moreover, there may be more of this nonsense ahead. Learned a lesson, fortunately not the hard way, several years ago and was less experienced. Had taken a modest position in American Tower, in the $50’s I think. Was going up nicely and in $70’s. Happened to check one day and it had dropped sharply. Didn’t have stops. Turns out Muddy Waters had done one of their hit jobs. I figured out pretty quickly that it was a bunch of flimflam and held my position. Stock recovered but lot of investors got scammed. Drop was so sharp and recovery rather fast that people who sold or got stopped out had to re enter at a much higher price. I think I commented before that I thought Amarin would be a candidate for this kind of shenanigan. There may well be more. Like the Farmers Insurance Commercial: “We know a thing or two because we’ve seen a thing or two”
This or something like it should be part of every Amarin public statement.
Vascepa is not fish oil, purified or otherwise. Vascepa is Icosapent Ethyl, a derivative of the chemical molecule Eicosapentanoic Acid (EPA), one of the omega 3 polyunsaturated fatty acids. EPA is found in fish oil, algae, and certain plants. More technically, Icosapent Ethyl is a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol....Icosapent ethyl is de-esterfied, converted into active EPA, and then absorbed in the small intestine. It reaches peak plasma concentration in 5 hours post-oral administration. Very little (<1%) is left circulating in the plasma as EPA incorporates into phospholipids, TG's, and cholesteryl esters. Vascepa is 96% or higher purity Icosapent Ethyl.