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Yes, Tasty - you seem to have very reasonable assumptions that align with my DD.
200 million mt seed oil production annually give or take.
1 million mt fish oil production annually give or take 250k. Algae is inconsequential currently.
113-118,000 mt of EPA from that, depends on the fish condition, etc as previously posted about. That’s IF you captured ALL OF IT for V API. Impossible for many reasons. So, your conservative estimate is as good as any of ours. For ease of use (that is cost-effectiveness) as raw materials, Peru and Chile are where it’s at.
AMRN has plenty of API capacity to tap into with refining suppliers for the foreseeable future - to paraphrase JT. Thousands of tons could be allocated to AMRN with long term or multi-year supply agreements - up to 2 years probably when supply is long like it will be if Peru’s catch is good then the supply chain wants long term contracts to guarantee a home for their production. The inverse is also true, in years when the crop report doesn’t look so hot, and supplies tighten up, then suppliers may only feel comfortable renewing at 6 month contract lengths (or they’d start dramatically raising the price to account for the additional pricing risk so they aren’t selling at a loss) - hence, the importance of being a “partner” in the supply chain - such as it is in commercial relationships, just as with any marriage.
Between now and 2029 - as V sales “prove” there’s a multi-million patient market - then mid + especially isolate refining capacity will expand incrementally. But, it’s not going to be like 5,000 mt of high end refining capacity gets Berlin airlifted overnight after Hawk_Driver’s helicopter vanguard does a protective flyover; rather, its a multi-year process. It takes time to approve sites, etc. For example, does anybody want a chemical refinery abutting their backyard? Also consider ever since the Brasky study, O-3 sales have been declining/flat - V should help reverse that trend. But, in the aggregate 2020 usage of O-3s for DHC might look essentially flat once again.
I’d guess API costs could swing from 0-15% (possibly higher) range given whatever all else is going on from year to year. AMRN margins have been around 74%, so low margins of mid/high 60% and high margins of 80%ish. Others have opined on what insurance negotiations can do to their margins - so that would come into play as well. I believe these widget margins are not that unusual for naturally sourced biologics, right? 2020 and early 2021 - should be pretty smooth sailing for AMRN assuming civil unrest continues to abate and no other big issues arise like a key refiner catching fire. That will give them some wiggle room to induce more insurers. Maybe 2020 then, 78+% margins?
Others have their own views, that’s cool. This is just how I look at it TastyOptionsRme - and it seems consistent with your models. Hooray for consensus building. -SK
Hey Tasty treat, I can’t remember from all the analysts’ reports posted here that I’ve read off Ihub (somebody probably does), but I’ve thought those levels possible since post Q2 with the growth rates ramping. I’m behind and not likely to catch up on some of the boards postings late Oct/early Nov and so haven’t listened to Q3 call - seemed more of the same from a glance.
I think totally doable with even only gentle tailwinds on formulary tiers - I count on Duke’s messages for “sentiment” on that topic as he follows that pretty closely. Good stuff.
Yo, Yo! You da Irish Bossman - clearly JT is more tight-lipped!
Glad to see you’re back here and that you held. Now that you’ve watched the ADCOM, how do you think we trade based on your TA best guess, heading into JPM assuming no real surprises on FDA’s final label - min/some/all primary, all secondary populations. (If label narrowed to only secondary, then my BO #...maybe I cut it by a quarter or a third and expect deal closure pushed back to late 2020/early 2021 instead b/c harder negotiations?)
My guess is $20B +/- $3B (or Tasty’s CVR Christmas wish)...but I can’t guess at which month a deal would close next year. Before July 2020?
I’m still sticking with as I’ve posted before about $750-$800mil as a sales estimate for 2020. JT may say something in January like - we are/have secured options/rights/supply on $1.2B in API (as long as psychological level of at least $1B it will be perceived well, IMO). Bonus: keeps it fuzzy enough for people to spend weeks on social media debating what it means (sustains high “engagement” levels)! I agree with KCSVEN, JT will likely announce lower sales estimates than this & it will disappoint some, but BO whispers will keep a rattan floor to the price.
JMHO.
Jamaalish - I haven't been on the board much longer than you, only since last fall.
My overall view is that wild caught omega oil supply is definitely sustainable for the next ten plus years. I don't consider it in short supply currently. Even in some future el nino years during the patent life, the price will adjust to meet heightened demand. Do I think 7.5 billion people have enough O-3 in their diets. No. So, in that sense I think there is a "shortage" in our diets because our O-3:O-6 ratios are so off. I also think the pace of ocean warming is accelerating and with it lots of changes for cold water species over some indeterminate epochal period.
If we only take the two countries where currently AMRN sources their anchovy/sardine oil from, in mt-
Year Peru + Chile Crude Oil Annual avail EPA estimate at 18%
2018 378,000 68,040
2017 218,000 39,240
2016 194,900 35,082
2015 206,200 37,116
2014 259,000 46,620
5 yr avg 251,220 45,220
You can compare your V patient # estimate for 2019 to the above and see that AMRN has a long way to go to use up these sources first before even tapping into other regions.
[# of Patients 2019] x 1460g = [(# of total grams demand) / 1,000,000 to convert to mt]
That said, there is only so much ultra refining capacity available for V - you can break this out like the below at 70% or use 65%, whatever, as refiners are probably always making incremental concentration gains. There are many ways to mix and match the various refining technologies as all the refining stages aren't usually carried out in one plant.
Distillate: >30-70%
Concentrate: 71-84%
Isolate: >85% (most limited refining capacity here at the top and V requires around 96+% purity and the ability to separate ALA, DPA & DHA from EPA since they stick together like birds of a feather)
Other than the GS analyst's low-ball, it seems most of the others have honed in on 8 to 10+ or so million peak patients per year as reasonable. That's supported by the amounts of crude fish oil from Peru and Chile alone. You could back calculate from their peak estimates to derive an inexact # for today's level of refining capacity. I'd expect that capacity to grow and maybe wall street analysts are using too conservative a % growth in capacity. Or maybe not, based on whatever their DD has turned up. I dunno!
Some of my other supply thoughts for when patient counts start soaring into the millions, 2021? and beyond (although some other Ihubbers disagree with me that there would ever be a scenario in which API prices would materially increase from AMRN's supply partners since they think any effects would be small...):
1) El nino years make things tricky from the volume contraction. Producers then gain more leverage to raise prices and push on other terms of sale. If the producers of the oil don't pay the fishermen enough then they will delay fishing or they will take their limited landings to a different plant who will pay more for the whole anchovies. El nino years can also push producers into bankruptcy which spurs more consolidation of the remaining survivors, which in turn, increases producer leverage with concentrating refiners. It also gives say Chile more power in negotiations if Peru is out of the equation.
2) Limited capacity or bottlenecks in manufacturing steps create leverage opportunities for suppliers in the supply chain. Suppliers and customers could actually have a more balanced relationship with neither dictating all the terms of sale, all of the time. To produce at the isolate level for pharma, well, V isn't a synthetic powdered drug where there may be hundreds of plants to choose from, because V is more niche and at least requires familiarity & equipment with natural liquid oils. I still think margin swings are possible in negotiations with key mid-concentrators or isolate refiners depending on prevailing market conditions once patient counts are in the millions. It's both a blessing and curse not owning their own plant. Mostly a blessing even with the extra challenges.
3) Direct customer involvement as a partner in the supply chain and increasing sales will allow for additional capacity investment. But, hard to peg how many months lead time for various capacity builds & the requisite audits, 16 months? Seems like AMRN has experience in this from back when they were prepping in 2012 for a 2013 launch.
That's my version of an AMRN supply view from a cruising altitude.
Jamaalish - Most farmed carp (China) has about 250mg of O-3 per 100g, if that. And even that's assuming the carp are grazing on the right species of algae in the pond water or getting it through their feed. Any oil that is captured from farm species trimmings would go into other animals' feeds. The lipid content and quality would be too variable to chase pharmaceutical markets.
From the Tocher report I just posted a moment ago on pg 12, section 8.3:
Cool Will Lar. Douglas Tocher published in Nutrients this 20 pg paper this past January. www.mdpi.com/2072-6643/11/1/89/htm
It's worth a read for the current state of affairs of alt-sources of EPA. Veramaris is producing limited commercial quantities as of July according to their PR - they say they have used selective straining instead of GM to get to about 10-16% EPA (?). With aquaculture still taking 70-75% every year of O-3 fish oil the focus has primarily continued to be what can be produced to supplement farmed salmon needs since they are viewed as the best dietary food source of EPA/DHA (a. O-3 TGs retained in their muscle meat + b. 1.1 efficient feed conversion ratio c. high enough market value to be commercially viable even with feeds constituting 50-55% of prdxn costs). The logic 15-16 years ago was that if 18/12 is about the O-3 ratio in lower trophic (forage) species then that's what should be bioengineered into alt-sources for farmed salmon to mimic natural marine nutrient ratios.
There's a dearth of research into the topic of EPA vs DHA in the diets of farmed salmon. Maybe mostly EPA would be healthier for them, too? But, the chart below shows only the following limited commercial development from the above referenced paper (could be non-reported, private stealth development going on):
Also, there is new EU research going into mesopelagic species, see MEESO www.ices.dk/news-and-events/news-archive/news/Pages/Mesopelagic-resources-IJMS.aspx.
Finally, Gaspar Jekely and others have very intriguing research into some of the simple mesopelagic species which begin to validate Michael Crawford's theories. DHA (nervous system & eyes) for the photoreceptors to gauge ocean depth & different kinds of light responses (certain type of light = move up via beating cilia actively and then passively not moving cilia to sink which allows them to maintain stable depth ranges until light type shifts which means the nerve cells have motor functions). Clues from our evolutionary background showing why different organelles might oxidize various long chain fatty acids. phys.org/news/2018-06-eyes-itphotoreceptors-marine-plankton-depth.html
Will Lar - you aren't a contrarian in my mind, you've always been open that you've forgotten a few details from the ten years ago when you were following EPA more closely. The larger outline still remains in focus for you however from what I can tell. I read your posts and say to myself "he still gets it..."
If you are ever in Seattle - and care to, I'd be happy to meet up and hear more about what you've been up to over the last 10 years if still in life sciences. With a handle like "Will Lar", if from Scandinavia, you'd certainly blend in at any of the Ballard bars. I figure you've got to have an interesting history on how you landed on EPA way back when.
BTW all, more good news from this week--> Peru announced a 2.8 mil mt 2nd season quota (Nov-Jan) which was above the 2.3-2.5 mil mt consensus forecast. So, I called the direction correctly a few months ago when I saw the NOAA South Pacific forecast (can't remember what I guessed for the #). Crude fish oil prices are very likely to remain low in 2020. The geopolitical situation is better in Peru than Chile, but it sounds like both are still fraught (Peru's tension has gone more sub-surface with many seething that Fujimori's daughter is in prison and the Fujimoris have both been viewed as better for business despite the corruption...). I saw last week Delta had even canceled and was offering refunds for flights to Santiago. This week the protesters are easing up a little since Pinera made some constitution concessions. It sounds like its outsiders formenting a lot of the trouble in Chile - they have over 1 million Venezuelan refugees who can't find work in addition to their own young people trying to get by on $450/month after getting college degrees... There's always something to spice things up at the end of the day, eh?
It was a very positive week and I'm super happy 16-0 about the ADCOM vote. I'm glad AMRN left no vote behind! Thanks to all who were there in DC and posted - I always like first person reports as the richer color almost made me feel like I was there. PS - I also like FFS visualizations. They help me see some of the buying behavior history I otherwise miss.
I have some more interesting science stuff that I've learned about that I'll post soon, but a friend is waiting for me to head up to go hiking at Rattlesnake Ridge now. Cheers!
I'll second that!! '72 Dolphins.
Woohoo!!!!
topic 2 a fib/flutter/bleeding - panelist clinicians seemed fine with results. suggested risk can be managed with labeling & post marketing surveillance monitoring project.
now topic 3. then a break and topic 4 afterwards.
I've barely been connected myself today. Really krappy webcast...
They just started discussing the FDA disc. topic 1 right now.
Wilson said overwhelming secondary prevention trial - no question. But, primary is the sticking point. yadeh, yadeh
Nice. Thank-you Dr. Paul Ridker...
Yep JL. Unfortunately, I know vegetarians who are obese with fatty liver disease or Type 2. Come to think of it, I don't know any vegans who are though - they tend to have an ultra-marathoner aspect.
Have you seen the movie "Last Breath?" It's about a commercial diver on a deep sea rig in the North Sea when a storm comes up. Interesting what happens as he was breathing on a helium mix and in the context of the Nobel Prize last week in medicine on how our cells behave when oxygen levels drop. trailer
MNBioMike- their FAQ supply comments were totally fine (pet food/feed probably in their 90% calc). AMRN's consumption today is such a small part of global supply. I'd like to see AMRN hit $750-$800 mil minimum in sales next year any more would be great. What does your CPA side think of that $24 BO # in that ridiculous GS report?
Also for a little more context, aquaculture has been hammered in the news for the last couple of weeks - a few scandals (like in Newfoundland; as reported in The Globe and Mail). Last year aquaculture was a media and investment banking darling...this summer seemingly the sector has been rotated to the bottom of the lineup (for now). The report yesterday was well-timed for today's Senate hearing. www.commerce.senate.gov/2019/10/committee-announces-hearing-on-aquaculture
As author Kate Atkinson wrote "a coincidence is just an explanation waiting to happen."
MNBioMike: AMRN was proactively responding to another general purpose attack from this Dutch NGO/foundation: changingmarkets.org/
insert-text-here
See British celebrity chef Hugh Fearnley-Whittingstall - apparently he supported the report. It's a bit of a neo-colonialism charge along the lines of we in the West are taking protein sources from developing countries --degrading their food security-- to support our own unsustainable lifestyles. They've layered on climate change for added emphasis.
This is connected to the plant-based diet movement which is gathering momentum - and they would like to shut down aquaculture (not just land based meat production). We are going to see a lot more "evidence-based studies" and reports like this pushing us all in a plant-based direction. NGOs inevitably refer to the China Study to support their position. However, if you look at small studies of Asian Indians who have increased CVD rates among those who are vegetarian, then you find that its not as simple as getting us all to eat soy and pea (pulses) flour products that have been baked/fried/cooked in various veggie oils (which raise AA levels). Instead people don't eat enough greens (and when we do - we tend to drown them in veggie oil dressings here in the US) - which have good AOX levels.
From what I can tell, AMRN was very bold to see the Reduce-It trial through to a successful conclusion. It's so easy for NGOs to attack and criticize, and immeasurably harder to create original evidence for the good of public health. I assume, EPA reduces residual cholesterol crystals among its other anti-platelet & immune system toll-receptor effects (like Dr. GS Abela's theory from the early 2000's as cited by Dr. Mason - and you can see the BP they were receiving research funds from back then). I don't see how anyone can "see" Dr. Abela's SEM images of sharp cholesterol crystals piercing membranes and think baked veggie bars are the dietary answer to 7.5 billion people on the planet. We need more EPA (and AOX) for our cardiovascular systems not more AA regardless of where we happen to have been born.
LOL. Yeah, & why did Pete Carroll give them an extra ring on the 1 yard line? That was the dumbest play call ever.
Tasty, when I was a kid, I hated the Bills and Redskins.
I stopped paying attention to the Dolphins after Ricky Williams imploded (those dreds rocked!). Too demoralizing.
I guess I am guilty as charged per JL's description as a simple Simone, because I started loving them when 5 years old in kindergarten because I thought the helmet on their head was sooooo cute!! Those were the good old days of Shula, Marino & Clayton and Super Duper. I just checked the list of all time win/loss records .pct:
.561 Pats (#4)
.556 Dolphins (#5)
.490 Eagles (drumroll please...#20)
Clearly, Brian Flores has them on the fast track to nowhereville. So, I'll continue to follow other stories instead like AMRN and their upcoming NO VOTE LEFT BEHIND -- ADCOM campaign.
Signed,
Always a Dolfan at heart (I'll put paper bag with eye sockets cut out-- back on now)
and additional q&A from STAT chat with AF:
Oct 10, 2019 8:53 AM
Nick O.
How much doubt (a lot vs just some like 50/50 panel vote vs panel votes for approval but only barely) does the AdComm need to express to convince the FDA to ask for another Vascepa trial?
Oct 10, 2019 9:12 AM
We don't know yet how the FDA will pose questions to the panel experts or what those questions look like. That's why reading the briefing documents when posted on Nov. 12 is so important. The numerical votes, if any, are important, but so are comments made by panel experts. We should have a good idea of how the FDA will act once the Nov. 14 concludes.
Oct 10, 2019 9:08 AM
Yen
In regards to Amarin, what do you think are the key questions for the adcom? Is it the triglyceride cutoff level for the label, broader CV prevention label, or more about the safety and placebo effects? But FDA was aware of the trial setup and the placebo used...
Oct 10, 2019 9:09 AM
All of those issues? See my prior post here.
I think AF is sticking to his same story as before:
BELOW FROM STAT "chat" with AF:
Hey Michelle -- Mirati asked and answered, but definitely follow up if you still have questions.
Re: Amarin (AMRN) -- I could probably conduct an entire live chat on this single stock and the upcoming FDA advisory panel for Vascepa. Hmm… maybe I’ll do that.
The FDA advisory panel is Nov. 14. The FDA’s briefing documents, including its medical review of the Vascepa data and questions/topics for the panel experts, will be posted to the agency’s web site on Nov. 12.
What do I think will happen on Nov. 14? I predict a positive vote, recommending the expansion of the Vascepa label to include the CV risk reduction data that came out of the REDUCE-IT study.
BUT…. this doesn’t mean the road to that positive vote will be smooth. FDA convenes advisory panels when there are unresolved issues or questions that require discussion or feedback from experts. We don’t know why the FDA decided to convene a panel for Vascepa, but we can speculate!
1. The impact, if any, from the mineral oil placebo. The REDUCE-IT data suggests the mineral oil was not inert. Patients in the placebo (mineral oil) arm reported a 10% increase in LDL-C (bad cholesterol) at year one versus 3.1% increase for Vascepa patients.
There was also a 33% increase in the inflammation marker hsCRP for mineral oil takers vs 14% increase for Vascepa.
The theory is that mineral oil may negatively affect the absorption of statins that nearly all patients took during the trial. And if true, this could have skewed the CV risk reduction reported in the trial. In other words, Vascepa’s 25% CV benefit might not be as large as indicated in the study.
Amarin conducted analyses showing no material or negative impact from the mineral oil placebo pill. Even those who believe mineral oil may have skewed Vascepa’s benefit higher believe it doesn’t erase the benefit entirely. But all of this could be a discussion/debate topic on Nov. 14.
2. Related mineral oil topic: Will the FDA want Amarin to conduct a follow-on study to determine the impact, if any, that mineral oil might have on statin absorption. Worst case: The panel decides that drug-drug interaction study is needed BEFORE FDA expands the Vascepa label. Disaster scenario! Probably unlikely, but still a risk. More likely, if a DDI study is needed, it can be done after approval of the expanded Vascepa label.
3. Prescribing details for the expanded Vascepa label. Amarin wants the new label to include people with baseline triglyceride levels of 135 mg/dl or higher as the indicator for increases CV risk (and therefore good candidates for Vascepa.) The data from REDUCE-IT, however, showed that most patients entered the study with higher median TG level. (There weren’t many patients with TG levels in the 135-150 mg/dl range.
Basically, there could be a discussion about appropriate TG levels to include in the Vascepa label. This sounds esoteric and deep in the weeds, but it’s important because it could potentially enlarge or shrink the potential pool of Vascepa users.
I’m going to have more to say/write on Amarin ahead of the Nov. 14 panel, in partnership with my colleague Matt Herper. This includes an interview/conference call with a cardiologist on Oct. 25, as part of our partnership with Slingshot Insights. You can sign up for that call here: https://slingshotinsights.com/projects/1129
Thanks Raf. Good post. I had read BioB's pacer posting last night. I failed to make that connection. I haven't been following the nitty-gritty of the Generics case.
I'm speculatively reading this as:
- Generics have subpoenas to GSK on dox relating to TG lowering
- Generics wants AMRN sNDA & exp. witness dox about TG lowering
- AMRN and GSK both are slow-walking the Generic dox requests (good!)
So, Generics likely trying to show that TG lowering (via IPE) shouldn't be patent protected via all their current machinations.
In 2019, after R-It results, suddenly only now it's becoming "obvious" to the experts that benefits derive in a dose-dependent fashion. This WAS NOT obvious to the experts in 2010-2018. In fact, IIRC some were saying that too much could be harmful.
I'm guessing many were surprised by the ADCOM. See the timing of the media articles like Sci Am - appeared around the announced priority review date for media momentum generation, etc. The articles would have taken awhile to craft and get approved for publishing (they aren't published the day of, in other words). But, buzzkill - ADCOM in Nov means dose-dependent articles were left flapping in the wind last week.
Too bad Mayor Pete can't focus on reducing the influence of middlemen.
His plan reeks to me. "march-in rights" UGH!!
STAT article below:
Buttigieg unveils an aggressive plan for lowering drug prices
By NICHOLAS FLORKO @NicholasFlorko and LEV FACHER @levfacherOCTOBER 7, 2019
Pete Buttigieg
Democratic presidential candidate Pete Buttiegieg
ETHAN MILLER/GETTY IMAGES
WASHINGTON — South Bend, Ind., Mayor Pete Buttigieg on Monday unveiled a sweeping plan aimed at lowering prescription drug prices — and though he’s one of the most moderate Democrats in the 2020 presidential race, the plan is anything but.
Buttigieg’s proposal includes a number of drug pricing ideas once seen as radical, including a policy change that would force pharmaceutical manufacturers to forfeit as much as 95% of a drug’s revenue if the company refuses to negotiate prices. “Worst offender” drug companies could also forfeit their patent rights.
“It’s time for a new era of leadership in Washington ready and eager to make drugs affordable and take on pharmaceutical companies,” states a policy paper that the Buttigieg campaign shared with STAT. “Pete has the courage to break with the status quo by focusing on real solutions that will lower costs and make needed—even life-saving—prescription drugs available to all Americans.”
Buttigieg’s drug pricing plan is the latest sign that while Democrats differ dramatically in their vision for the American health insurance landscape, they are far closer together in their willingness to take on the pharmaceutical industry. While Buttigieg has sought a middle ground on health coverage via his “Medicare for all who want it” proposal, his drug pricing plan displays an appetite for aggressive drug industry reforms on par with that of candidates like Sens. Bernie Sanders (Vt.) and Elizabeth Warren (Mass.).
Buttigieg’s plan for negotiating the price of drugs is very similar to a high-profile plan released by House Speaker Nancy Pelosi last month. Both would direct the HHS secretary to negotiate lower prices for expensive drugs and would penalize drug companies with rapidly escalating taxes if they couldn’t agree with the federal government on a price. As under Pelosi’s plan, a drug company that refused to comply could face a tax on the drug’s revenues beginning at 65% and escalating to 95% with continued noncompliance.
Perhaps most striking about Buttigieg’s plan is his embrace of so-called “march-in rights” — an idea to empower the government to approve generic drugs in situations when the brand drug maker still has a valid patent, citing the same law Pelosi forebodingly referenced in a summer 2018 meeting with the lobbying group PhRMA. The idea has been embraced by the progressive wing of the Democratic party, but is still controversial among more pro-business Democrats.
“For ‘worst offender’ pharmaceutical companies that continue to price in a way that harms patients due to unaffordability, when attempts at direct negotiation are rebuffed, and in cases of national emergency related to either a natural disaster or a public health emergency, Pete will judiciously exercise these rights,” the plan states.
In a seeming recognition that the government has been unwilling to use these rights previously, Buttigieg also pledges to appoint an attorney general “willing and able to defend these rights.”
While the plan hits the drug industry hardest, other industries aren’t spared either: Buttigieg pledges to require that drug industry middlemen, for example, report a slew of currently secret information to the federal government, including the amount of rebates they receive from drug makers.
Buttigieg’s plan is also among the most detailed of any presidential candidate to date. In addition to big-picture ideas like negotiating drug prices, it includes smaller policy changes like including generic and biosimilar drugs on the lowest insurance formulary tiers, capping seniors’ out of pocket drug costs, and cracking down on pay-for-delay patent settlements.
Buttigieg’s plan is so wonky that it even gives a special shout out to the Netflix “subscription” model being piloted in Louisiana to pay for costly hepatitis C drugs, and details the national security risks associated with drug shortages.
The plan tackles drug research, too, albeit in its own way: Buttigieg pledges sustained investing in the Biomedical Advanced Research and Development Authority and the Army Futures Command, two largely unknown military-aligned research centers.
He also pledges increased funding for the Food and Drug Administration’s bioequivalence research, which examines the physiological differences between patients taking generic and brand drugs.
New investment in O-3 refining sector:
- Epax plant output to increase by 50% in 2021, on €32m investment
- mid-concentration up to 70%
www.nutraingredients.com/Article/2019/10/03/Epax-omega-3-plans-include-32m-facility-upgrade
Already been going on for awhile in terms of fortifying foods (instead of naturally occurring)...
insert-text-here
If anyone would like to drill down into the subject more, I'd recommend this textbook--
https://www.elsevier.com/books/oxidative-stability-and-shelf-life-of-foods-containing-oils-and-fats/hu/978-1-63067-056-6
I met one of the authors earlier this year, she asked to borrow a pen from me. I had no idea that I was seated next to a rock star! She told me taste and stability are the on going developmental issues with respect to fortifying foods with long chain fatty acids.
Also, FM CPG world (fast moving consumer packaged goods) is facing dramatic upheaval - trends change on a dime. The focus is often on "flavor systems" and increasing shelf life (a lot by way of packaging enhancements such that one can see more bright and cheery plastic especially 1 or 2 single serving size than actual food in the supermarket). As demanded by retailers and their investors who want GROWTH NOW NOW NOW (or like yesterday ALREADY ALREADY ALREADY). As cutthroat as pharma/biotech seemingly.
Cheers!
Flubber, I had flagged that particular Chinese algae company because of the species they are experimenting with back when Nuke'emtiltheylaugh, JL, JoeMotorCycleRacer and I were last talking about algae in July after Veramaris' feat. If you check out this Chinese company's website, they have like 9 mt of EPA. Always a long distance from benchtop to true commercial quantities.
This Opinionator has an enriching flare for the dramatic and she appears on TV as well. www.creators.com/read/michelle-malkin/03/12/obamas-algae-racket But, it should give you a good idea of the position of some in the US. Thus, if we assume no additional government investment then that will leave private investment - from large enough companies to subsidize the long timeline to scale from their other product categories. Which of course, means they are large enough to be vertically integrated... Stealth development is always possible. But, usually if you need investors then you have to publicize at some point.
No, supply issues that I see right now. I could be thinking in terms of say a SWOT analysis. And within that litle heatmaps with many shades of green, (yellow), and red. So, increased instability in Peru, in my mind, geopolitical risk went from light green (from green after Garcia's suicide earlier this year) to pale yellow. Not FUD, just a different way to scrape for signals in all the informational noise. Some prefer, black or white. Different mental ways to slice the data cake.
All the beer drinking conversations got me thinking about Tom Long former CEO of MillerCoors. He was ousted after several years success of enjoying 3 year supply contracts on hops (Washington State is the #1 hops grower in the country in Yakima Valley), malt and aluminum. IIRC, there used to be up to 10 year marketing orders from the 1937 Agriculture Marketing Agreement Act (govt enforcing crop prices) which has been done away with. Really, beer has been trending as a very local commodity due to craft beer growth - making it hard for the national brands to show growth. Hops supply previously had been a bottleneck for the craft brewers who need it for that pine cone punch and various aromatics from the resins- (https://www.seattletimes.com/business/agriculture/market-for-hops-could-go-from-bloom-to-bust-as-growth-in-craft-beer-slows/)
www.chicagobusiness.com/article/20150210/NEWS07/150219994/millercoors-ceo-tom-long-retires-after-4-years-with-chicago-brewer
LarryBird, #6. That's beyond awful. I'm sorry to hear that about Elisabeth's son. I had no idea!! One of my friends moved to Seattle after 9/11. She couldn't stand to be in Manhattan anymore (grew up/family still there, went to Columbia and then worked in mid-town) after what she experienced that day.
For the record, even though I'm a fan of BO...I'm NOT a FAN of BO for the regular employees. My empathy resides with regular employees during and post-BOs...so if AMRN should somehow GIA, hmmmm. Generally speaking, I'd like to see more American capital reside with employees incentivized through our corporate tax structure.
#5. You left out Kukes... Have you ever watched the Showtime series Billions? Grossly overacted except for Giamatti and Siff (her character is my favorite).
Wags to the Dollar Bill character, "Forget it Bill, it's chickentown." Reminds me of your Jersey Shore vacation post - a memorable one!
So nice of all you guys, thanks GG & JL.
Ha! Sex Matters-- or do men rust faster?!
- men have more iron because they have more hemoglobin = more chances for oxidation reactions even though FE2+ bound & ringed up protectively in heme from O2 under healthy conditions = partly suggestive of why CVD presents earlier than in women
- women have smaller vasculature including at the peripheries so does EPA insert into the intima as easily in a woman's smaller microvasculature, maybe the extra pressure from the narrowed lumen helps? (I might have to ask Mason this one?)?
I found two videos that to me were compelling on the differences between men and women with respect to CVD, or now I'm learning CMVO below. I'm well aware of the breast cancer awareness campaigns, but had never heard of the "Go Red" campaigns. I thought it was a "whale tail" pin they were wearing -- oops!! It's a red dress!
Gulati: insert-text-here
Noel Baery Merz: women erode / men explode
Sex differences in hemoglobin for multiple species also driven by testosterone & estrogen levels: www.sah.org.ar/pdf/eritropatias/CADAE1408C.pdf
I'll get Gulati's kindle book version on heart disease in women as soon as I finish "Ticker" which might already be past due at the library (uh-oh!). Bud Frazier - what a character! (I had to look up flight surgeon in Vietnam since I couldn't understand a surgical theater on a helicopter while the pilot was dodging bullets. I might have to read "Sharkbait"!). And then I'll reach out to Gulati with some of my newly hatched questions if she doesn't answer them in her book.
Raf, thank-you for re-posting that entire Twitter exchange from Nov 15 2018.
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I'd hate for AMRN to lose any "yes" votes from the clinical trial's ADCOM jury, as it were. The other Mama Mama doctor commenting on Bhatt and Gulati's exchange to broker a Twitter peace by acknowledging both sides, is suggestive of the tone deafness that I recalled. I get it based on the date, Bhatt was feeling exultant over a successful and ground-breaking trial and Gulati in tune with what resonates with her social network... was raining on his parade that day.
I can't think it would be that difficult, as tiresome as it may be, to acknowledge difficulties in recruiting women - a year will have passed from last year's AHA when the ADCOM is held. Something like, "Thank-you for pointing out this real issue. Yes, we only had 28.8% females in the trial which on the surface seems a little lower than average. We screened 19,212 people. X # were women who didn't meet the inclusion criteria. We carefully selected the inclusion criteria as being the ones that cardiologists when typically polled said were equally relevant to CVD patients of either gender to avoid gender bias. ETC"
It doesn't sound as dismissive as saying that somebody is trying to score a "political point" or an even more perfectly poised... you're sending patients to an early grave with that viewpoint.
I went back and scanned the NEJM paper - and it looks like I can see Gulati's cursory at-the-conference-POV (left arrow - wider confidence interval than for men). Then part of Bhatt's reply, the p-value for interaction (right arrow) which essentially standardizes those two estimates for male and female, to create an estimate of the size effect to be able to compare to other studies. So, she'd have to have a Cliff notes of other estimators for other relevant trials...to compare or else just compare to the other interaction effects from within this trial like the Trigs, right? It'd be like if I said I weigh 300 lbs. Unless we know everyone else around me is 100 lbs, the 300 lbs doesn't say much in isolation. From my limited way to understand the nuance here, this p-value for interaction statistic in CTs - did Bhatt and the stats team select the Hodges-Lehmann estimator here, too? Which would be somewhat like a Peoria scoring system in golf - making it robust and fun where there aren't set parameters (player handicaps) by bringing all levels of players into a narrowed score range?
Onerag - Seems to be a lower # of women referred for screening in cardiovascular trials according to this JACC 2018 investigation. At least these authors say minimal clinical differences for efficacy and safety between the genders.
At any rate, R-it does appear to have a lower female participation rate, see quote at bottom.
www.onlinejacc.org/content/71/18/1960
https://www.ajmc.com/focus-of-the-week/women-are-still-underrepresented-in-clinical-trials-for-cardiovascular-disease-drugs
Wasn't female enrollment like 28-9% in R-it? I thought it a weak (at best) comeback myself when somebody posted Dr. Bhatt's retort on a Twitter feed to a fellow MD as merely being a "political point" because he said CVD affects women, too.
I hope he can re-frame his responses to that potential line of inquiry for the ADCOM.
www.npr.org/sections/health-shots/2016/12/19/506144346/patients-cared-for-by-female-doctors-fare-better-than-those-treated-by-men
The rivalry between Peru and Chile goes way back to the War of the Pacific.
I think there's some truth to both customary transnational squabbling between the two and that particular anchovy stock moving southward and closer to the coast.
With some luck, Vizcarra might really diminish the power of the Fujimoristas. <fingers crossed> But, I'll keep my koolaid drinking here to a shot glass size instead of from a fire hose.
https://globalfishingwatch.org/news-views/worlds-largest-commercial-fishery-publicly-tracked-on-global-fishing-watch-map/
I'd like to see Peru resolve this quickly. But, its certainly not a good thing if it drags on.
Peruvian politics - always as corrupt as anywhere. UGH! I hope Chile isn't next.
Excellent post JL. From my viewpoint, most industries at least those related to the sciences in some way have Phds data scraping others' field or original work. And then like the Wellcome Trust/Cochrane they align themselves with the true owning class (foundations/think tanks attached to the very, very wealthy) to establish the "standards" that were often already in place, but are just being re-packaged as the haute cuisine for science consumption. And unsurprisingly, as I've posted in the past - these data scrapers always position themselves at the top of the pyramid.
They are heavily marketed on process. And light on original efforts. Go figure.
(There may be some minor benefits to Harvard's nutrition dept highlighting dosing...but, 1) detractors will note the low level of benefit from mixed O-3s and 2) practitioners will remain in their respective thought camps that much longer...."are we there yet??" ...ie, at 40,000 O-3 studies/trials??)
Parent company = BASF. I mentioned Cognis back in July.
1000% agree JL. I'm not a fan of meta-analysis in general. Most of these third party orgs (Cochrane of CTs) are parasites.
I hate Madame Butterfly! Are you fricking kidding me??
Asian lady with child pines away waiting for her white soldier to return? What's there to like? She should have been on IPE therapy to help her mental health and then she wouldn't have needed to commit Mama-san harikari. Summer before last it was the ONLY opera playing in Santa Fe. I wanted to see an outdoor opera for the sunset, so Madame B it was. Did I just admit to seeing Butterfly out loud? So embarrassing, but the sunset was amazing. The buddy I went with - he loves M. Butterfly. Figures.
Glad I won the worst analogy ever award today. Somebody had to.
JL - I know. And who is going to take 8+ mixed grams daily without dropping off?? Especially once they have insurance coverage.
Be prepared for A LOT of dosing analysis articles to come out over the next year. As you can see today, it's not going to be just Viet Le talking about dosing.
Well, meta-analysis proponents wouldn't agree with you about needing to test theories with trials. I recently read a pretty good theory that the Cochrane (what BS!) fish oil meta-analysis last summer which had strangely clear-cut their way through the trials seemingly unrelated to typically acknowledged importance/decent design--
Looks like Cochrane selected based on pushing ALA over EPA/DHA.
OMG. So ridiculous, but unsurprising. Cochrane. London based. Prince Charles. NGO goons who want us all to convert to plant-based diets as soon as possible to "save the planet."
And yes, high drama. Captured in my new Ihub image - HAHAHA! Martina Arroyo playing Cio-Cio San. AMRN investors are like Cio-Cio San. And the FDA is like B.F. Pinkerton. ADCOM...the long awaited "return." <groan>
Exactly. People don't start pontificating without an interest and I agree Kiwi here its most likely reputational.
Point taken, Raf. Scientific American could have said formerly associated with KD Pharma for a brief period - but, that would be such a minor part of Dyerberg's overarching role. I was more focused on that Dr. Dyerberg would be like the George Washington or Thomas Jefferson of this space. So, people would still look kindly if he had a brief stint with this or that company.
I'm not sure who that would make Dr. Preston Mason to be like - a 2nd or 3rd generation figure of some importance as well, William Marbury?
There's another Scandinavian who is right up there in terms of being a founding father in O-3. I'm forgetting his name at the moment - an Icelander.