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Onerag: I did say and you are agreeing there is a lot to this case. You seem more convinced that it's a good thing for the ITC to be involved in drug oversight instead of sticking to trade issues. I do not see it that way.
Yes, the public facing board members are full of the position that the ITC appeal is going to be an upwards catalyst. I think only Kiwi was saying DS are DS at one point.
The esterification process alone is not the way you get to an over 90% purification level on these LCTs. You need another step or an entirely different process. (That is good for AMRN)
North mentioned last week that the chemical engineering side hasn't been much discussed either. I can see a lot of confusion on the board as to how V is actually made. There are even people on the board claiming that V doesn't come from fish oil. I realize that may be to set some kind of mental anchor or for humor (cognitive shortcuts), but there are others for whom it appears they are genuinely confused.
I view the ITC appeal with more caution. Again, we saw what happened with the AHA catalyst.
1) A drug - the ITC deciding what's a drug? LMAO. I'll know to avoid pharma in that event as it will be just like the AIA and what's happened with so-called patent protection - forget start-up bio-techs getting anything past BP - BP will go back and forth between FDA and ITC running the little guy ragged.
2) EPA and DHA were on the market prior to Oct 1994. EE versions did exist prior. So, now the court you're saying is going to retroactively find that DS EEs, all of them, were drugs all along? Dr. Clemens Von Schaky was running studies back in the mid-80's with purified EPA and DHA from various DS manufacturers - you can find his studies from that era. So, there were a lot of studies going on. We can probably go back and find the obligatory rats being studied with fishoil EEs as well.
Were they "substantial" studies? How are we going to define "substantial"?? as a Phase III clinical trial (pre-emption clause in section 301(ii))? This is why I said the FDA needs to weigh in with some determinations. AMRN could be negotiating for a stricter approach on enforcement by the FDA - again behind-the-scenes and we wouldn't know except via a FOIA. With R-it results I think AMRN would be in a good position here to ask the FDA to protect as clinical those higher concentration levels.
Requiring FDA definition then, terms in bold:
Was there a substantial clinical investigation that had been instituted or made public prior to Oct 15 1994. Lovaza/Omacor (the first Phase 3 clinical trial)was published in Dec 1994, just after DSHEA.
The ITC doing this...really...
3) I read the Laerdal medical devices decision last month, and? Extensive diagrams showing specific parts of a device to make it easier for CBP agents as I recall...gets to my point of concentration levels or some kind of roadmap.
Legal argument wrangling can go on for forever - happy hour in DC is full of it and it is kind of fun like political or sports teams debates because we don't know what will happen. I was just tossing out a reason to view the ITC appeal with caution because it could be tailored or narrowly defined somehow. "Activist" judges sit all over don't they, after all?
The bulls don't appear strong enough for now to overcome the manipulation or options controlled range as FFS pointed out - so the ITC appeal may not have much effect or for very long at all.
Onerag: AMRN is trying to use the ITC as a gatekeeper at the border (that would be the stick or enforcing of any decision). If AMRN wanted an investigation into whether DS are "actually drugs" they knew the answer already and that's why they didn't go to the FDA. FDA guidance previously has been that concentration and purification are OK.
DS were sold in the 1980s and were considered GRAS - generally recognized as safe. They were legal before and after DSHEA's passage.
AMRN's case is a difficult and grey one to take to the ITC otherwise why did the ITC NOT want to review it in the first place?
The questions really belong with the FDA. How does CAFC ask the ITC to conduct an investigation without involving the FDA? Pom v Coke was about Lanham Act (trademark) protection involving TM labels, but really it was about concentration levels of blueberry juice in drink bottles that showed pictures of blueberries and pomegranates even if the drink only had .5% (Coke) which disadvantaged POM.
www.supremecourt.gov/opinions/13pdf/12-761_6k47.pdf
So, again, smart and aggressive to aim for the sky by AMRN, but SCOTUS in Pom v Coke tried to thread the needle.
Which is why I suggested what I did assuming CAFC uses that case as suggested by AMRN to send it back to the ITC (which would have to work with the FDA). They don't have to use it of course.
Right, that's AMRN's argument. I get why JK took this position. It's smart and aggressive. And it recognizes their IP.
The hard part that has to be reconciled is that at low or mid concentrations - fish oil EE supplements were already being marketed to the public on the East Coast out of VA and NJ and were GRAS. Then DSHEA 1994 grandfathered them in.
So, there's a lot of history...the FDA thanks to DSHEA has a lot of grey area here that they legitimately need to do some rule-making on.
Which FDA definition says an EPA-EE molecule can't be labeled a DS? I haven't heard of that one...
Dr. Bill Harris was using ethyl ester supplements for his human subject studies prior to DSHEA...Pharmacaps was producing EE supplements in the 1980s.
I just don't think it's logical that a new NDI would be needed every time there is a new catch of fish to be rendered with different FAPs - ie, different levels of EPA that are then refined/concentrated (utilizing ethanol)....then every step would have to be patented to account for every possible naturally occurring starting concentration difference instead of applying AMRN's patents to a clinical variant (with their IP percentages) which would be overseen by the FDA?
That's why I suggested it - a possible reason why the ITC appeal is dragging out.
I bring it up because I don't necessarily view the ITC as a catalyst to shoot to the moon. ;-P I'm just remembering the AHA as an upwards catalyst predictions. So the ITC will cause a reaction, but it could go either way, that's all.
We've got the grind of monthly sales increases. Whatever the ITC hands out. BO potential.
HDG - sure. But, what would the investigation into imports be about?
That's where (potentially) one can get into discussions regarding concentration levels and IP being infringed upon by the imports.
An ITC investigation can do nothing for a 99% pure EPA EE produced say in Miami, Florida from menhaden caught in the Gulf of MX. That's where you need the IP.
So, you end up back with AMRN's IP at some point.
Tasty: Dr. Phil Calder, first name on the references cited in this USDA sponsored meta-analysis would probably be surprised to see his long promotion of O-3s used to say ALA and AA essentially don't need to be reduced in Western diets.
I posted previously referencing him #152572.
Here's a video from May 2018 where he speaks to the importance of increasing our O-3 PUFAs. At about 20 minutes in, he speaks about emulsions which was the subject of my original post. Dr. Phil Calder on O-3s
I'm not surprised that the USDA found the right studies for their meta-analysis for AA and ALA...are you? Not to mention that if our cell membranes are already saturated with AA...2-4g may not actively help Dr. Nissen because our diets are so poor overall, but corn oil is not inert.
Dr. Eric A Decker at UMass and formerly Dr Guodong Zhang (I posted a slide from one of his studies when MO was blowing up after AHA) are KOLs in the area of lipid oxidation studies (all edible oils are subject to rancidity which affects human health negatively, so AOX researchers make important contributions here).
Let's take some rats that are evenly balanced in their diets (or at least not skewed in their diets like ours) and feed them corn oil and track their biomarkers. That's what Dr. Zhang did. Of course, he was interested in oxidation, so he used both oxidized and un-oxidized corn oil. Both corn oil interventions induced the production of pro-inflammatory cytokines.
Dan - I agree with you except it might be worthwhile to flesh out a little more your last sentence. Bears are likely to jump back in with all the news attendant with that ruling. Its a VERY watched and high profile case.
Yes, on the need for a catalyst. But, has the board dug into the ITC appeal much? I've been wondering if the delay in the appeal decision is because extensive negotiations are going on between all interested parties to find a way to thread the needle. In other words, the decision may not be an either/or. It may be 5 Shades of Grey (I live in Seattle, what can I say?).
Remember, on a normal timeframe it would have been decided back in August.
It's very likely that the "decision" is being negotiated behind-the-scenes.
How are we defining a win or a loss?
To me, a win would look something like:
AMRN's IP on EPA EE protected. Maybe ITC "oversees" FDA process to regulate--
it could look something like this?
90-100 % high concentrates - AMRN IP
80-90% % - AMRN IP
60-80% % - AMRN IP/DS (split may fall in this range like @ 65%)
<60% - DS
** I think the full R-It results on 11/10 would bolster AMRN's negotiations with FDA that for diseased patient populations you do need a clinical formulation (to guarantee a. purity + b. concentration levels) and therefore, high concentrations can't fall under DSHEA since DS are so lightly regulated. And that Lantham Act is the wingman to this position like in Pom Wonderful vs Coke (2014).
See Mango's post # 164548. I'd read that article before, too. But, scroll down on its references cited to #18 for the link to the amicus curiae brief by Joe Cwik and Deanna Okun (for CRNUSA, GOED, and FDA angle of attack). IP attorneys all around the country are following this case closely.
But, how does the market react to any ITC "win" scenario? We just saw what happened at the AHA.
Yes, it's as though we have to draw a picture of a capsule like on all the supplement websites and show the % concentrations versus a capsule showing only EPA.
After all the comments on the board today I reached out again to our benefits manager who will call our CVS Caremark rep tomorrow. It's crazy that he said CVS Caremark covers Viagra off-label under most of the various plans they offer (excepting one value plan that specifically excludes "lifestyle drugs" which our company is not on).
So why wouldn't CVS cover VascEPA off-label?
What a farce.
STS: Great link, thanks - I like the Gestalt Reality blog. I'll have to dig into that one as time and understanding permit.
Here's another if you don't already have the link from the Wellcome Trust - www.lipidmaps.org
I may have to use some of their images as a new handle for Ihub. I think Google is working on a human cell atlas. Exactly what we all need - Google Earth, but for our bodies.
Sharinky: Why do you feel a need to post comments on that website? That article accurately captures the state of the marketplace prior to an appeals decision by the CAFC on the ITC decision not to institute.
These types of articles and websites are a dime-a-dozen. Supplements are cowboy territory.
Kiwi-
If you really want to expand sales ...get with most of the Western world ...some basic health care coverage for all
RR - As an NSAID you got V covered with CVS?
All my cholesterol #s, etc are normal the last time I had them checked - so no way to get it covered with CVS that way.
LOL Tasty.
Did you read the article on price-fixing by the generic cartel I posted??
"The sandbox"... MWUA HAHAHA.
A veritable caricature of salesmen.
Toano: Yes, I completely agree. On last weeks webcast while I realize JT can't go into detailed sales strategy without giving away information to competitors, he basically asked for patience on the US market. If I'm remembering correctly, he did get asked and talked about UAE.
Unless, JT and Aaron Berg are attempting to kill two birds with one stone such as by travelling together on the long flight to Abu Dhabi to pursue sovereign wealth fund investments into AMRN, while following up on "opening" the 9.4 million person UAE market (30% cardio disease rate = 2.8m people from which we can assume some much smaller percent of those have TG>500) then we should be hearing a lot more on what AB is doing here in America.
I hope we get some higher quality generalized USA sales updates post R-it (some of the color behind the aggregate script #s) from mgt for Q4 and Q1 2019.
-45% Obesity rates in Gary, Indiana? Uff da.
-Cleveland, OH...
re:CVS Caremark - here's a copy of the benefit plan I am under with them.
CVS Caremark
They will NOT pay for anything off-label as I previously reported on this board (for me, analgesic/anti-inflammatory benefits). And yes, generics first.
I hope AMRN is educating CVS at least for indicated cardio patients with their current label - what generic exists that isn't a DS for clinical (FDA regulated) EPA EE in the US? None that I'm aware of.
Regarding generic cartels (over 300 drugs caught up in the net) in the US - today in the WAPO(MSN) - I know we're all cynical about efforts to chase wrong-doers by the Feds, but price-fixing does get busted:
www.msn.com/en-us/news/us/investigation-of-generic-%E2%80%98cartel%E2%80%99-expands-to-300-drugs/ar-BBQJwle?ocid=se
LOL. JL- are we going to start up on krill oil again? KO has some different properties as I’ve posted on previously. (PL attached to glycerol along with 2 fatty acids). The krill need that PL as anti-freeze (better membrane permeability in icy waters so they don’t freeze.). It’s the same reason most of our fishoil comes from cold water fishes- they need the longer chains PUFAs with kinks so they don’t freeze up.
Dilution is pollution, most of the time in most industries...nutra is but one of many in that regard. Extra ADR shares, anyone?
-SK
Tasha10: I'm curious if you still track NEPT? I saw your post # 1413 where you talked about their patents. It looks like in late 2017 Aker BioMarine bought that IP for $34 million to end the "Krill Wars" since now they will have the supply cornered from ocean to pill. NEPT appears to be focusing most of their efforts on marijuana oils. krill wars over
KD Pharma also seems to be focused on blending marijuana (cannabinoid) oils with fish oils for therapeutic benefits in the nutra channel as well as finding new uses for other fraction off-cuts. Nutra KD Pharma new blends
Slick KD Pharma video (scroll down on their home page):
KD corp sales video
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Aker updates for those who watched Robin Leach back in the day, Kjell Rokke is like Norway's Donald Trump (his son sits on the board of the Philadelphia shipyard and helped build one of Exxon's newest ships) and in addition to the new krill vessel which will start in 2019 he's also building the world's biggest and most technologically advanced ocean research vessel tied to his own private ocean research foundation:
www.sciencemag.org/news/2018/11/norwegian-billionaire-funds-deluxe-deep-ocean-research-ship
www.boatinternational.com/yachts/editorial-features/vards-record-breaking-182m-extreme-build--34157
www.yachtcharterfleet.com/luxury-charter-yacht-53303/rev-photos.htm
nordic.businessinsider.com/norwegian-billionaire-has-ordered-a-high-tech-yacht-set-to-become-the-worlds-largest-2017-5/
And of course, you need a foundation to go along with it- revocean.org/
Needless to say, he likes power boats. What do I have to do to get a week of shiptime on the Rev? LOL!!
The wife's boat (she prefers sailing) isn't this sailboat gorgeous - Scandinavian design rocks!-
www.vitters.com
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As any good consultant's pyramid of value shows-
Pharma has exquisitely high margins, while food/nutra has decent margins + volume.
Forbes top 400 American billionaires - select for food and pharma to compare the # of billionaires in each category (look at how many Cargill family members on the list) www.forbes.com/forbes-400/#4802fdfd7e2f
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Speaking of b-consultants, what were they saying last year on Pharma? KOL's are the bare minimum. It looks to me from the outside like AMRN is capably pursuing the latest business development pharma trends to a T. www.bain.com/insights/how-to-make-your-drug-launch-a-success/
Happy Sunday!
North: This is kind of Pharma 3.0 language needed to establish on-going credibility with all stakeholders (focus on healthy outcomes) isn't it - and partly why AMRN has priced V as a value drug?
I don't think there is any escape from the juggernaut that are various en vogue certification schemes which for healthcare seems to take the form of "evidenced-based health policy." Generally, I've understood a lot of the patient empowerment movement to be traced back to the Karen Ann Quinlan case and the thalidomide scandal which hastened the transition away from formerly paternalistic doctor roles.
Generally, businesses and organizations end up having to go along on certification schemes. If I'm remembering correctly one of the first was the Forestry Stewardship Council. They've exploded since the late 90's to over 450 eco-labels across all 25 sectors.
Cochrane seems to want to fill the certification place in the healthcare space with "evidence-based" meta-analysis studies under the guise of bringing order to the snarled studies jungle. Unsurprisingly, Cochrane appears to be junking it up themselves with their own definitions of what to include in a meta-analysis study to benefit the growth of Cochrane.
Quickie Cochrane process critique
Billionaire wants a shiny badge like in Candy Crush - once they get bored with owning a sports team, what's left?! > Billionaire funds NGO/consultancies > NGO/consultancies copy template from other certification schemes and applies to a new unopened frontier > supply chain reacts and eventually rolls over & uses as market differentiation > Consumers mostly don't really care except to avoid being shamed in front of peers when polled and many don't realize the added cost in supply chain for what was already being done prior to the added layer.
Certification schemes can be a job creator for all the new science grads who can't find jobs in academia or government. Over the last 20+ years our government agencies increasingly use consultants like Grant Thornton, Booz Allen or Dyncorp for functions that previously were in-house. Ironically, this has ballooned the budget in unforeseen ways than possibly had Uncle Sam kept the functions in-house (the policy thought experiment is the tax-paying citizen is better off because the cost of paying benefits/401K contributions has been sloughed off to the consultancies), but it doesn't necessarily work out that way in actual practice. It's a government equivalent to what is visible on the private sector side with what are essentially marketing companies who farm the bulk of their functions out be it pharma, commodities or software.
A sign'o the times.
BioB: Excellent post. A FOIA request with the SEC could be interesting, too - who knew what and when and how did they benefit or should I say still may be expecting to benefit...
Afish: Absolutely, you've witnessed a lot of AMRN history from across the pond. What are your jaded Euro thoughts on AMRN former board member Simon Kukes? Could be he still has 1-5% of AMRN shares. You were getting in when he was selling off some of his shares if I recall correctly from when I reviewed those historical SEC filings recently. He flits back and forth between big and little oil.
simon kukes the guardian sept 2018
kukes dallas news may 2018
Also, see Pacific Energy (NYSE:PED) and SK Energy. Some new SEC 13D/As filed over the summer. PED also has a board here on Ihub. I may have to hop over on that one, too. Let's see Condi recommended Rex T for State because of Exxon's walled off interests in Russia...
Remember what I posted last night...Did you know on Russian fishing vessels they always have a honeypot on board so that when the fisheries observers climb aboard for an inspection they are well taken care of? I mean look at how happy Kukes is with his PYT - he must feel 19 again. Lots of new shiny baubles to buy to keep her happy - red berry Christmas trees for this happy couple, too?
Is the blue caterpillar smoking a hookah yet?
MJ PYT
HDG: Thanks. Will look for that line item in 10Qs.
Yes, that would be the hope if the refiners look at upgrading their facilities to continue to chase higher margin concentrations. A shortage might work to AMRN's advantage in expediting an API plant approval in the US by the FDA. Drug shortages seems to be one of Scott Gottlieb's pet issues - although more for hard to source injectables according to the press.
This could be why AMRN is teeing up "supply shortages" since its au courant in DC right now as well. Just thinking out loud here.
HDG: re:B. Yes, I've been paying attention to that as well. In addition to the European plants previously talked about on here, then with the addition of Nissui -
that would add their
Kashima plant for the SPD and trans-esterification steps
Tsukuba plant to remove the AA by reverse-phase HPLC
I'm not sure how much additional capacity Nissui would have beyond what they need for EPADEL domestically. Its not unheard of for Nissui or any manufacturer to have CMO agreements that they conveniently set aside to meet their own highest priority needs first, most lucrative, and then you have to chase them down for penalties.
But, that's always a risk for any company that doesn't own its own plants. While I've always said actual fish oil supply is fine - I have always thought its going to be a juggling act for AMRN's Derek Kalinowski at some later point (not in 2019 or probably 2020 either) to have enough refining capacity set aside for AMRN for their EPA EE needs.
I trust he's working on maybe partnering somehow (setting aside grievances) with a couple of likely candidates domestically - getting their plants approved. It is very difficult to get to these high purity levels - only select plants are technically even capable of it is my understanding.
I doubt the encapsulators would be a bottleneck except for a time lag from when AMR101 ships from the refiner in 55 gallon drums- 4 to a pallet and maybe 19 to 20 pallets per 20' container/truck - (55 gallons = 190 kgs per barrel) to the encapsulator. I'm guessing that 4 barrels of oil could yield about 4,850 - 120 count bottles. But, I'm not sure what their encapsulation yield loss would be (20-23% too high?) - so lots of assumptions in that estimate.
The pharmacy folks can weigh in on what a standard shipping box count is for 120 count bottles or how much is typically inventoried regionally (how many weeks or months worth in a pharmacy?).
At any rate, it's definitely a complex global supply chain: not everything happens at one site.
Inv: Short term - lately, whenever AMRN's price swings...I think of that Bollywood song.
Long term - it's what Dr. Clemens Von Schacky said back in 2001...paraphrasing, but to the effect of whoever has the first successful clinical trial --- WINS!
Von Schacky has worked a lot with Bill Harris on the O-3 index and also has done a ton to promote O-3 research and understanding - just like members of this Ihub board.
Stuff this board already knows, but from a German cardiologist:
Dr. Von Schacky
Inv2992/King/Chas et al: Thanks and sorry to hear about your health issues Inv; I hope the Esselstyn diet helps. I checked last week and since I'm looking at EPA to test as an analgesic on my LBP, CVS Caremark wouldn’t cover V. The last time I had labs done was when I read the above book, so I’m not a candidate on the cardio front.
Amazon delivered OmegaVia's .5g caps on Saturday which I stuck in the freezer. I've started at 2g/day for two weeks (AM and PM) and then will go to 3g if I don't notice substantial pain reduction. I’m going with OmegaVia because this board mentioned it, but also they follow the voluntary DS industry IFOS certification scheme. Manufacturers have to send in oil samples for testing and file those lab results with IFOS, so that consumers can look up a specific batch to verify its authenticity. It doesn’t mean they couldn’t fill capsules with a different batch, but I think most of the DS who would go to the trouble to be verified want to distinguish themselves from the less scrupulous or fly-by-nights. I’m sure PharmEPA is fine too – you can always call and talk to them. DS are very much a cowboy world – by design with DSHEA to remove regulation. This was Orrin Hatch’s intent and his son is still a lobbyist in DC working to keep it robust I think.
I do spend a little armchair time thinking about global food policy – which intersects with global health in myriad ways. A really good book which won a Financial Times best book of the year award, if you want to deep dive into it is “The End of Plenty – the race to feed a crowded world” by Joel K Bourne, who was educated as an agronomist at NC State. I had to chuckle when Pyr posted twice about DDT – India is the only country where its still legal and the salt-of-the-earth farming villagers look for cheap OTC cures to protect (block) themselves from the pesticide’s ill effects. I'm also familiar with Paul Farmer's works (as well as others) and once in awhile look at WHO reports on growing antibiotics resistance. BTW, I also appreciated reading AVI and others for powering through and explaining graphically the trial data so well – it helped me tremendously, too. Or OY with the FDA process. It takes time to explain in plain English complicated subjects. The visuals help me big time on the TTU (time to understand).
We have an ongoing field trial of 330 million Americans eating a high O-6 diet (and our pets with their kibble, too). Corn, palm, canola (rapeseed) and soy make their way into so many components of our diet. A composition analysis of today's broiler chickens show high AA because of the plant meals in their feed- I forget how much. I've graphed in the past USDA statistics comparing beef and broiler annual production and consumption in the US - chicken (about 110 lbs per capita) far exceeds beef (58 lbs per capita) in the US. I was curious whether there was a genetic component that might cause us to preference AA - again an adaptation to combat pathogens successfully when we used to forage for food. It appears there might be - AA like MSG has a certain umami 5th taste that we like and once again Japan is on it. www.jstage.jst.go.jp/article/jpsa/55/3/55_0170123/_html/-char/en
Here's more from Capt Joseph R Hibbeln, a natural ally like JL, who has done a lot of research into the effects of our nutrition not just on civilians, but also on veterans - insert-text-here
I think of it as my chicken McNugget theory in terms of why we consume so much more chicken – I forget what year it surpassed beef. Ray Dalio, of Bridgewater was largely responsible for bringing about the McNugget and he has a new book I downloaded this past week titled "Big Debt Crises." www.cnbc.com/2018/05/03/how-ray-dalio-helped-launch-mcdonalds-chicken-mcnugget.html What's in that fry oil? www.wired.com/2014/07/whats-inside-mcdonalds-french-fries/
As this board well knows - all the big Ag companies are looking at other ways to get marine type O-3s back into our diet, but it's still a little ways off - you either have GMO or very expensive, high energy SS vat SCO brews - which means food price inflation to right our heavily weighted AA ratio if we don’t come to terms with GMO in our food supply chain. There are no easy answers as people’s livelihoods depend on the current system. All the organizations that are supporting actors in the marketing story like the AHA depend on income from labels ("heart healthy certified") or donations and a few well-placed Vietnam era rabble-rousers like Nissen who perhaps unwittingly delay things long enough until some of the billionaires maybe like a Bill Gates work to push money to the foundations to release studies (new marketing stories) showing us how good GMO edible grown oils with EPA are. I don’t know what they will do to the pests that feed on the crops though? www.philanthropy.com/article/Who-s-Raising-the-Most-The/244933
In Utah, Romney won this month of course. But, Mia Love (R) who had taken over for Jason Chaffetz on the House DS committee just lost to Ben McAdams (D). Romney is even higher profile than Orrin Hatch and comes with a huge Bain constituency as we all know. So, while pharma probably spends on R&D alone about what the entire DS industry creates in economic value in a given year - to Utah the DS economic value and jobs creation is sizable. Utah's newest senator doesn't go in as a "junior" horse trader - and how does a Bain acolyte keep his voters happy or in other words, view value creation - a little bit of dis, a little bit o' dat, like the late Cajun chef Justin Wilson would say "I gar-on-tee dat":
No wonder musical stories are popular for relief for our world's complexity - sprinkle in song and dance to get a fast dopamine and serontonin pop.
Dil Dhadakne do
Buck: FUD. China's rendering plants that take tilapia trimmings don't produce any oil of consequence. Tilapia is a freshwater fish AKA carp.
Check out our domestic catfish industry or the invasive species of carp in the Mississippi River that USF&W has unsuccessfully tried to find partners to have harvest. Only carp derbies are viable - bring your bow and arrow. But, same thing - no commercial oil. Where would the EPA come from anyways? These aren't fish that have much O-3. In fact, like chicken in the US - tilapia have a lot of O-6.
As far as V knockoffs in China - you already can get supplements of fish oil in China like you can in the US - but it's not that easy. In fact, it's easier for a small entrepreneurial company who wants to export to China to have young millenial ladies with suitcases travel abroad usually to Korea or Japan and bring it back in their luggage.
Also, 94% of Peruvian crude oil exports go to China first. They are the traders who gamble on collaring the anchovy oil market - they could strangle anchovy oil world markets if they wanted to, but as it turns out they still prefer selling the oil domestically to make feed for: baby pigs, fish, turtles, shrimp and eels. Anyone who doesn't watch trade flows and understand what they mean - is crazy IMHO. Look at phosphorus. We're lucky we have 4 states that have a lot to mine. Other countries wish they were so lucky as China or Morocco.
China has "blue hat" (health foods), "orange hat" (supplements), and then pharma registration processes with CFDA (now called SMRA) which take minimum about 10 years from when you start for supplements or pharma. Most of their protocols are imported from the EU and the US to a lesser extent - their protocols are often retaliatory in nature. The process like anything in China is arduous and made more so by Trump's tariff sabre-rattling. China's CIQ and AQSIQ are scrutinizing all documentation that much more closely. These are the reasons I'm not currently counting on anything to happen in the short term in China for AMRN and why I focus on the US market for at least the early part of the remaining 10 years on the patents. Our current president should pipe down - you can't fix 30 years worth of trade policy in 1-2 years. Ask the soy farmers who needed a $12B bailout (our biggest primary diet source of AA acid, by the way)...or else the farmers would go back and vote on the other side of the aisle.
I was just in China a few weeks ago - the mood has worsened and unsurprisingly they blame the US. I just heard of more bankruptcies in China yesterday in fact (like the tariffs effects on our domestic auto industry, eg, GM - collar steel imports to the US and it provides a convenient reason to cutback production even if its just a small part of the weak American manufacturing story). It's easy to be diffident unless you are one of the folks who has a job tied to international trade.
Imagine if Walmart did an "American First" stunt like Germany's Edeka did in one of their stores in Hamburg? The shelves would look like the below video.
Edeka responds to tRump
I prefer facts to FUD - whoever the messenger might be.
Thx for posting Zu. It's a very good presentation and addresses the need to have both a clinical strength and high purity level of EPA walled off & protected as per AMRN's patents for diseased patients.
Spot on STS - Corn oil fatty acid profile (FAP):
Which we humans like my 24/7 corn loving daughter convert to AA:
Isn't it interesting that some ferns which appeared 360 million years ago have a relatively high AA ratio? www.australianoilseeds.com/__data/assets/pdf_file/0017/7064/vyssotski,_mikhail_00235.pdf
EPA ancient molecule - yes, built for fast(er) action like a soccer midfielder.
Earth's core as O Mg Si Fe. We know Carl Sagan who said we are all descended from stardust.
Lynn Margulis, his late first wife, said "the animal's food, becomes the animal's body" or “Life is a planetary level phenomenon and the Earth has been alive for at least 3000 million years. To me the human move to take responsibility for the living Earth is laughable - the rhethoric of the powerless. The planet takes care of us, not we of it. Our self inflated moral imperative to guide a wayward Earth or heal a sick planet is evidence of our immense capacity for self-delusion. Rather, we need to protect us from ourselves.”
Lynn Margulis interview on symbiogenesis
Lynn picked up the story where Carl left off.
Also, Neil Shubin, paleontologist and evolutionary biologist: Your Inner Fish
Cell manifest destiny: https://prezi.com/efljo-431pty/cell-analogies/
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We don't want cavitation in car shocks:
Or on the back end of our submarines - Nat Geo Navy cavitation
But, we want cavitation in the kitchen - how a blender works
Or in the lab when we need to pull apart cell bits to study things like specialized pro-resolving mediators (SPMs) made from EPA, etc -
Or for new ways to deliver the drugs -
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Which leads back to cavitation as a possible theory on how earthlings began:
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Longer chain compounds last longer and are in deep storage to possibly (among other reasons), tide body/cells over during drought periods such as with Vit K2 or DHA for their shorter chained siblings.
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The germ/microbe/virus reason for inflammation fits like the continental drift theory. We've been in a constant state of battle with all the infectious disease spreading vectors like hookworm, mosquitoes, ticks, mice, bats, etc. Mosquitoes and ticks have perfected their anti-coagulants to keep their blood smorgasbord going. So, we get sickle-cell anemia adaptations in Africa. And Vit K differences like in Asians and AA genetic adaptations, too, all depending on what localized battles might be going on such as against Japanese encephalitis or malaria variants.
And what about horseshoe crabs? They have blue copper based blood that coagulates really quickly and use amebocytes to fight infections. Deep sea vent origins 450 million years ago = fun quirks today.
drrc1949: re:see Afish post #160668 if you want to re-read
Kiwi: Wow. Thanks for posting as I'm not on Twitter. I was scrolling through Sek's posts on his twitter feed and came across the name Bijan, which is an uncommon name in US (he's Irani) plus also in med field. Wondered if it was the same guy who dated one of my BFFs back when they were undergrads at Princeton. Bijan ended up going to med school at Columbia with Dr. Oz if I remember correctly. From all the stories I've heard over the years he's a great guy and they still stay in touch.
What a small world.
AFish: I could actually argue that your first paragraph makes the case for manipulation even more. It’s easy to draw whatever conclusions we want from the same data. A case of let’s cover our tracks and make sure we wrap things up at the end of the day with a smirk to show no trajectory whatsoever simultaneous with another article release.
Some people look at the stars and see evidence of God. Others look at the same stars and see hydrogen and helium.
Thanks for the CNN intl article on Nissen by the way. It put things into context with his stance even beyond the AZN angle. US baby boomer generation views were somewhat shaped by the 1960s. Kind of like German baby boomers who are still proving their green credentials.
Yoy: No meaning behind that other than I removed all 3 of the Ihub tickers listed because I wasn’t sure of the point.
I’ve been digging into the research on the anti-inflammatory mediator O-3 derivatives in regards to asthma and nervous system functioning. For example, Dr. Bruce Levy, also at B&W/Harvard (knowledge cluster) has been experimenting with EPA + DHA derivative compound based therapies for pulmonary conditions. It looks like the synthesis of Protectin D1 (in the airway mucous) and Resolvin D1/E1,E2 compounds is important for proper airway function. I’m trying to learn how this compares to some of the new advances in glucocorticoid understanding as well.
www.ncbi.nlm.nih.gov/pmc/articles/PMC4854800/#!po=23.1707
Here’s a 30 min FB live interview from Aug 2018 with him where he does mention at one point that they are looking to not only control, but resolve asthma. Levy and Nandini on asthma and neutrophil swarms
Yes, that’s what struck me. That now the judge is going along with waiting until Cisco appeal is wrapped up. In fact, steering it that way.
Mood and momentum shift.
JFMCRR: thanks for the yogurt trick.
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Deepak Bhatt and others - anti-thrombotic effects.
In 2012 - Dr. Bhatt and "novel therapies"
More history:
Oh, is this part of the answer to my question which was why Japan would be intensely focused on the anti-thrombotic effects of EPA EE. I wonder if its because the two populations are different as below?
Very interesting.
CBB: Kevin Tipton, Phd - a professor in Sport, Health, and Exercise sciences at the University of Stirling is very active in this area. He also has an active social media feed on FB, etc. The problem with a lot of athletes is that if you tell them 2-4g then a month later they are taking 6-8g. Athletes have a tendency to think more is better.
A lot of the focus in sports has been on DHA supplementation to help protect the brain from percussion injuries. But, there is also research going into is it a) muscle protein synthesis or b) effects from anti-inflammatory processes? How do O-3s affect this versus AA during weight training, after accidents with muscle atrophy, etc.
Nestle Nutrition, Novo Nordisk, GSK, DSM, etc are sponsors of research in this field. Remember Nestle sells a lot of infant formula that is supplemented with DHA, so if they can find new benefits of DHA for athletes then it gives them another huge franchise.
The NIH is also involved in the US, but I'm not sure without doing more research who exactly is looking at what.
MangoMan18: re:Dr. Harris' interview - thanks for posting it. I appreciate his understated midwestern style. He's been researching O-3s for a long time as he says. I like big history and there's a lot of it a la Walter Alvarez an earth sciences professor (or his physicist father Luis who won a Nobel prize).
In the below report check out pg. 28 of the 184 pages (marked 2-14) - William S. Harris "Fish Oil and Lipoprotein Metabolism." There are a lot of NOAA reports available detailing the American's early research efforts.
This is also a line of inquiry that is fruitful in understanding some arguments in the ITC case with respect to DSHEA.
Remember while the Americans started researching in heightened earnest after Jorn Dyerberg's Greenland Inuit paradoxical study, so did the Europeans and Japanese. It was like another race to the North Pole enhanced by better methods in gas chromatography. Now, we are using NMR where you don't have snippets of DNA available to test.
I'll try and do another post on Japan's history. I have some open questions to the puzzle that I hope some of the biochem or pharmacy folks on the board could piece together.
Duke: Interesting. I always appreciate reading the anecdotal evidence of people's actual stories on the board. Subjective experience might not rank as highly as objective data, but sometimes it points in the right direction of where to look for one's own situation.
I have mild asthma/allergies + periformis/LBP (perhaps from long distance sports- the LBP came on after doing the Vineman Ironman and trekking to the top of Kilimanjaro and never went away; Xrays/MRIs didn't point to anything conclusive). I also don't tolerate NSAIDs well. My 5th grader last May had her second bout of episodic urticaria. It was horrible as a parent to watch her intense itching and burning skin (way worse than chicken pox). Not to mention when the hives appeared on the back of her throat. Her pediatrician after prescribing prednisone and hydroxyzine (so she could sleep) after a week said to go see a dermatologist or immunologist. We went to her immunologist who said it was heat-induced urticaria and to stay on cetirizine. Unfortunately, it makes her really sleepy which makes it hard in the classroom. It cleared up in August (weather cooled off + the Zyrtec), but I since try to get her to take a fish oil daily in the emulsion form (the Barlean's 1500 mg smoothie she'll swallow without too much nose wrinkling). She's more motivated when in actual distress, obviously.
This board has me pretty much convinced to try switching to a more heavily weighted EPA formulation, but pills are too big for her to swallow. She's also a patriotic little American - it's hard to reduce her corn consumption. I'll find out how next summer goes if I can better her EPA/AA ratio.
Just another, FWIW.
Yes, thanks for that update Bfost.