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WTF? Does this mean Hikma was severed from the infringement case AND the case against Hikma was dismissed? Meaning AMRN can only continue to sue Healthnet for infringement? Did AMRN realize they had no case against Hikma so they dropped them from the suit?
Patents aren't awarded for running expensive trials - in fact, you need to file for them *before* you start even talking about such a trial - once your theory is public, you can't patent it. And R-IT didn't exactly prove the value or non-value of biomarkers wrt to CVD risk - but some day I hope they'll release the Lp-PLA2 level correlation with risk levels - won't be a patent issue, but will really help clinicians.
I've always wondered why JELIS didn't show obviousness of R-IT patents - and I'm worried about AMRN defending them in court - only saving grace is generics can't challenge in the EU for 10 yrs, but if we lose R-IT patents in US the EU then becomes fair game for generics with a decision in the mid 2030's.
At least KM is trying to pump up his CEO credentials - still waiting to hear what this "omnichannel approach" means, what it's doing and how - I'm guessing KM approached The CEO Magazine looking for free pub, and it's generally pretty good pub too - but who sees this w/o searching the internet for AMRN/KM stuff I have no idea:
https://www.theceomagazine.com/executive-interviews/food-beverage/karim-mikhail/
Yeah, that's what I was talking about, indirect costs of CVD, but this number sounds extremely low to me:
Thanks - personally, I would hammer them for not taking hospital and economic costs into account when evaluating a new drug - QALY is only a small part of the total financial equation. You have an MI and end up in the hospital for 4 days like my little brother did last summer you have a large cost for the hospital bill, his lost wages for days he missed work (you don't go right back to work just because you're released from the hospital), the loss to his employer who didn't get his work contribution, cost of an ambulance ride and the EMS's it carried (huge in the US), plus some other costs I can't remember right now. I know somebody has come up with a total economic cost of an MI, either here on this board, or maybe AMRN themselves - can't point you to it though. It really chaps my ass that they actually claimed there is no group of patients for which paying for V makes sense - that's a ridiculous conclusion, and worse, it's based on a bunch of "what if's?".
Don't you think AMRN may run into pricing problems with other countries if they, for instance, settle on $240/mo with Germany but agree to only charge the UK $140/mo? Do drug black markets exist in the EU, meaning can you cross the border to a cheaper country to buy your drugs, like Americans driving across the border to Canada to get drugs? That's a generic question since the UK is no longer part of the EU and such travel and economic transactions likely wouldn't be allowed.
Thnx - after I quit reading the board yesterday I found that on my own somehow and was so disgusted by what I read I was too mad to come back here and list all the BS I found, which others have noted is really long - as in almost every section of that doc questions R-IT results and they conclude there is no UK population that would benefit from V, and it appears the cost was a huge part of their problem:
How about this gem? Many drugs, perhaps > 50%, do not have a fully understood MOA - that's not a valid reason to say "we shouldn't cover this drug" - and furthermore, not fully knowing MOA does NOT invalidate the empirical results of a 7 yr CVOT - the only thing that matters is "did it work or not?" - and CLEARLY it worked wonderfully. This attitude shows a very poor understanding of how medical treatments are guided by clinical trial results, NOT by "what is going on inside the body that produced the desired outcome?". I mean NOBODY has a frigging clue how anti-depressants work - does the UK cover them given their unknown MOA? Of course they do.
Doesn't matter if we're approved if UK insurance won't pay for it, and it looks like they're trying to find every reason under the sun to not cover it - unbelievable.
Ohmyfucking god - this group is saying V should not be covered by the UK health care system?!? How in hell did AMRN screw this up so badly, and will other countries follow suit?
I found this in the consultation PDF and couldn't believe my eyes:
Sounds like you watched a Zoom meeting between AMRN sales reps (and not high level ones from the sounds of it) and a committee responsible for negotiating V prices in the UK - just from reading your notes it looks like it was a total clusterfuck - NOTHING has changed as to how AMRN operates - why the hell was STRENGTH even a topic of conversation? And V doesn't cause fish burps - EPA+DHA does. AMRN reps sound like they knew nothing about the drug they were trying to promote.
Also, you wrote "UK Nice meeting - update sent to KM 13-01-22" - but your post is on 2/4/22 - any reason for the delay in writing KM and posting your comments here?
Jesus H.....what exactly is the UK's problem with MO? I don't see any easy way to find info about V's app at their website nice.org.uk. And the MHRA gave V MAA last April - so what's the problem? Is it over price negotiations? Have a link to the doc you're referring to?
Yikes! That's not very fun at all - didn't know Apotex was selling now, or that DRL had somehow overtaken Hikma, and damn quickly too - how'd they do that? V scrips scalped by 23% since Jan 2020 - ouch - proof GV is being used off label for R-IT, but what does AMRN do with the info in court, if they even can?
That plan sounds suspiciously like forcing patients into HMO's w/o their approval - that means you wouldn't be able to see the doc of your choice or go to the hospital of your choice - that's bullshit and dangerous.
This bit is a head scratcher - why on earth would the Feds be interested in a plan that could cost them even more money than the existing Medicare plan does?
Something didn't add up between that 13F and what I saw on WhaleWisdom.com for their ownership of ARMN, so I ran the numbers on Sarissa's ownership over time - they opened a position in Q3/21 with 8.5M shr at unknown cost. Then I added up the # of shrs shown in the 13F and the total cost for each lot, did some calcs, and discovered they also bought 8.35M shrs between 9/31/21 and 11/26/21 at a $4.98 basis, which put them at a total of 16,850,000 shrs at a basis of $4.94, which is 4.26% of shrs out, below the 5% SEC limit. The new 7.15M shrs they bought listed in the 13F have a basis of $3.30, bringing the total basis down to $4.46, total cost $107M.
Basically they almost did what I do when I establish a long position - they bought in three equal sized lots (by # of shrs), while I usually buy three equal cost positions - but of course I'm not an activist investor, nor a HF, so our buying methodology is not going to match - duh. And I bought AMRN in all different size lots at different prices in my IRA, eight separate lots in all. Don't feel like looking up my purchase history in the cash account, but it's probably similar.
I'm curious what they intend to try to get AMRN management to do to maximize shareholder value - with only 6% they don't hold much power. Maybe AMRN could bundle up the ROW (like South/Latin America plus small EU countries) and sell the rights to someone instead of their plan to find a partner in each country? How much would that be worth to someone?
Activist judges and politicians wouldn't even notice, nor care a whit, if AMRN exited the US market - they would just view it as a business decision - drug makers stop selling drugs all the time, you just don't usually hear about it unless it's tied to class action lawsuits due to people suffering injury or death from taking the drug. Even then you many not hear about it on the news - I've posted many times about the damage a class of antibiotics caused to hundreds of thousands of people, but didn't know JNJ had pulled their version off the market until I started researching how many billions they had already paid out in damages. Cipro still remains available although it has two black box warnings - for one, because it's the only antibiotic that can treat anthrax.
If you responded "give up the US market to save money" I would have replied "you're nuts, I don't want to have to take GV!!".
Wow - this is sort of scary to think of, but understandable from a corporate perspective - AMRN may abandon the US market if they can't at least break even - the fate of V selling in the US is likely going to depend on this new BlinkRx patient access program increasing the number of patients who start and stay on V instead of quitting after 6 months.
https://seekingalpha.com/article/4479030-amarin-corporation-plc-amrn-ceo-karim-mikhail-presents-40th-annual-j-p-morgan-healthcare?messageid=2800&utm_campaign=4479030&utm_medium=email&utm_source=seeking_alpha&utm_term=RTA+Article+Smart
Ah, I missed her - saw her picture but didn't read her title - and that thread was all about the new BOD member, thought he was who you were referring to - nevermind!
It is true - only Empag||f|oz|n had a lower normalized start to sales, and we're barely above that line, and just below the Br|||que line - Entresto and Effient uptake lines were 3X higher at the 3 month mark.
What's more concerning to me is what I just read in the JPM call transcript - Germany requires an ~ 10% discount to the $240 USD price, not bad, much bigger net sales than AMRN gets in the US (~$143), but in a question about price negotiations with other EU countries KM said that the discounts must go up in some percentage to the number of patients expected to be prescribed the drug - the more you sell the less money you make per sale.
He also made this statement:
What makes you think he's a new PR guy? He's just joined the BOD from everything I can find - nothing in the 8-K about him becoming an employee or being involved in IR - why did they need another guy on the board anyway?
Speaking of the 8-K, don't particularly like this chart on pg 18 of the new Investor Deck - V is on the bottom of the curve for comparative sales of a new CVD agent, presumably just in Germany because that's the only place you can start selling immediately after approval:
https://investor.amarincorp.com/static-files/cd8eef19-197e-4114-8612-e0ab7498301e
OT: Tech tip to anyone with a Honda or Acura built between 2004-2012 with a NAV system - the calendar and clocks are borked because of a stupid programming error akin to the Intel Y2K bug and there is no solution available until maybe August of this year - :
On 1/1/22 every Honda and Acura with NAV systems built between 2004-2012 suddenly had their calendar date revert to 1/1/2002, the dash display clock is stuck one hr ahead, and you can't adjust the GPS clock via the Setup page - it won't accept any corrections to the time - mine is stuck at 12:00. After some sleuthing yesterday I only found complaints about this from owners on 2004-2006 Acura TLs on Acurazine.com, but as I kept looking I found an article that said it was a global problem - god knows how many millions of vehicles are affected, and no solution is expected until Aug 2022 - poor programming of the original NAV system - the issue appears to reside in how the calculation of the GPS system time/date is hard coded:
https://tiremeetsroad.com/2022/01/03/honda-acura-owners-report-incorrect-date-time-issue-after-new-year-date-reads-january-1-2002-shows-incorrect-time/
Thanks to everyone who responded - so the oral hearing is about standing. Don't remember if EPADI got to argue standing live via Zoom with Du or whether she just took briefs and ruled - if it's the latter, at least the CAFC is giving EPADI the time of day to argue in person, albeit remotely. I know some folks who follow this board post Seeking Alpha comments to AMRN articles, so if this event is going to be broadcast live, could someone post a comment to a SA article saying what date and time it is being held, perhaps with a link to a post here with how to listen? I'll never be able to find such a post myself, don't have that kind of search capability as a freeloader. TIA.
P.S. Can't believe we hit a new 52 wk low of $3.11 today
The FC ruled EPADI has standing? Wow, that was unexpected! Don't really follow this board anymore - can you point to relative time/date or the post where I assume marjac was informed that the FC agreed he had standing? Would like to read the reasoning given that Du threw the whole thing out by claiming EPADI had no standing, so this is a stunning reversal in fortune.
But wait a second, you right conflicting statements about this:
They're going to sell more V in that island of Hainan than HLS sold in Canada the first year? IIRC you need to take a trip to Hainan and can only get 3 months of V at a time - bodes well for mainland sales.
Thnx to everyone who responded. Had a really nasty trading surprise this morning and wanted everyone to be aware of it because it was a massive lost opportunity buy - here's the rundown:
1. I own stock in the shipper ZIM
2. Today it went ex-div for $2.50/sh
3. Some investors aren't aware that because it's an Israeli company Israel withholds 25% of divs as taxes - pps should have dropped $2.50*0.75 = $1.87 at the open or pre-market.
4. I had a premonition it would overshoot the should have been $1.87 correction, might even overshoot the $2.50 correction, so I entered a GTC+Ext hrs stink bid yesterday for $46 (looked like it was going to close around $48.40).
5. Get on the PC this morning and see I didn't get filled but the pps was at $45.80 - WTF? (actually went as low as $45.63)
6. Was having major computer problems (AGAIN!!), everything kept freezing up, so I couldn't get to my broker's website to quickly change my bid - took me almost 2 hrs to regain functionality, should have just frigging rebooted. When I finally got things working the stock was $47 and climbing - my standalone trading software was likely the source of most of the problems.
7. Got into my TDA account online, checked order status, and to my shock my bid had been changed to $63.50 - they adjusted my bid for the div amount - WTF?!?! Got on the horn with TDA to ask why my my stink bid was changed by their system (how can a broker unilaterally change your price?!?), and after 20 mins of back and forth with his support team it turns out they automatically change bids by the div amount (didn't take into account the 25% tax either, which you cannot recover if you're in the US), EXCEPT for one specific type of order - if you enter a plain GTC limit order with TDA you will see a "special instructions" box below, if you click on it there's an option to "DNR", for "Do not reduce" the bid by the div amount - ANY other kind of order will not give you this option.
End result was by the time all of this crap got straightened out I had to rush out of the house for a dental appt. - when I got home the pps was already above my avg. price (was trying to avg. down on ex-div date), and damned if the stock didn't close +$1.25 (+2.6%) above yesterday's close - FUCK!! I am beyond pissed about this - I could have increased my position by 1/3 while reducing my basis by almost 4%.
Summary - I had a great plan, it worked to perfection, but didn't get executed because of some stupid trading rule TDA uses that can't be avoided unless you use a trick most people have never heard of - so be aware of this with your own broker if you try to buy stock with a stink bid on the ex-div date.
Obvious takedown on ARNA pps to lower BO premium - don't know how "they" manage to get this done, but we've all seen it before. ARNA was at $89 in Feb, although they had an official failure of one P2 drug trial for IBS - 3 doses and various levels of abdominal pain - but the largest subgroup, those on the highest dose with the worst pain, showed meaningful and stat sig improvement, and the stock did not crater after topline results came out in March. It did crater in Aug after Q2 results were released, from $62 to $45, although there was nothing really bad about results except net loss YoY went from -$1.61 to -$2.40 due to increased IR&D costs as trials expanded/started - they have a relatively large pipeline, including a PAH drug licensed to a SK biotech - no CVR for that program in the PFE deal. Terms of the deal are $235M payment from ARNA to PFE if ARNA walks away, including that they get a better offer, and $350M from PFE to ARNA if PFE walks away, like if one of their most important ongoing P3's announces failure before the deal closes.
ARNA was my single biggest position, owned it in 3 accounts since 2011 with some averaging down (AMRN close behind, #2 biggest position) - at least I won one of those huge bets - avg. profit for the 3 accounts is +130%, and only 1/3 of the # of shrs is in my taxable account, have enough write-offs to cover the taxes. Really thought AMRN was worth way more than ARNA in the long run, especially since I bought ARNA for Belviq, it's failed weight loss drug (pulled from market due to cancer problems, but never sold well anyway). This is a case of where not taking your losses and moving on paid off (the lost opportunity cost argument) - even survived a 1:20 RS and still came out on top. Hoping the "don't sell and make paper losses permanent" attitude pays off in AMRN as well - I'd be thrilled to get $15/shr and walk away from this POS stock - hell, I'd even take $13 - that's still a 100% gain between both accounts that have AMRN.
BTW, the market is not sure this ARNA BO is going through, and it definitely doesn't appear to think a bidding war is going to break out - ARNA only trading at $90 with a BO price of $100 on the table - will be interesting to see what happens the next week or so. But YIPPEE! One 10 yr held biotech millstone around my neck will be gone forever some time next year.
I know some things about the ELISA test since I've been getting them for 15 yrs - when my Dad said he tested positive for COVID on ELISA I was too shocked to think straight at the time, but a week later I was talking to one of my PTs about it and I started remembering more details about what that test shows - whether you have antibodies to a virus, period. When I got home I did a bit of research and what I suspected at her office was true, the test cannot distinguish between antibodies generated from a vaccine of from an infection, it's not that precise. In fact, most vaccine developers use the ELISA test in pre-clinical or P1 testing to see if the vaccine is creating antibodies, but the test is not recommended for use until 6-8 weeks until after a real vaccination to check for a viral infection. One of the reasons I hadn't thought about ELISA and COVID is because my doc only orders tests for bacterial infections, or viral infections for which there is no vaccine - nothing stopping him from ordering ELISA for mumps or measles but it would be a waste of money since I've been vaccinated.
So no way in hell my Dad got COVID - his ELISA test measured increased IgG antibodies from the booster shot he got. I emailed him about this about a week ago, the weekend before Thanksgiving, didn't get a response. But the day after Thanksgiving my older sister, the family organizer, said we were going to have Xmas at his house after all - YeeHaw! Whether my email and a discussion with his doc had anything to do with it I have no idea, but it couldn't have hurt - only condition is that we all self-test on the 24th - we celebrate on Xmas Eve to prevent scheduling problems with significant others and spouses celebrations - they get Xmas Day. CVS now has an FDA EUA antigen test in stores, $23 for a box of two tests, results in 15 minutes:
https://www.cvs.com/shop/abbott-binaxnow-covid-19-antigen-self-test-2-tests-for-serial-testing-prodid-550147
P.S. I think I may have gotten something backward in a previous post - IgM antibodies develop first but fade away fast - unless you have an active new infection they'll be negative for the rest of your life - IgG can indicate active infection, recently active infection, or past infection. The lab my doc uses doesn't put a value in the IgG column if antibody levels are below the negative reference level, but they always put a value in the IgM column despite the fact that they've always been negative for active infection in my case - that's a little weird (a value for a negative IgM result but blank box for negative IgG), probably why I thought IgM stayed with you for life.
What he wrote did not include the word "milestones" - if it's not in the contract, AMRN doesn't get a dime upon approval - I would think it is, never heard of a deal like this that didn't count approval as a milestone payment - you probably have it ballparked right, 10%-15% of total sales-based payments (which is another way of saying sales milestones).
Can't believe the level of traffic here hasn't slowed down - last time I looked the pps was $3.65, which put my cheapest basis account underwater - this stock is cooked, stick a fork in it.
Yeah, you'd think he'd be max protected, but realize the oncology CLL drug he takes wipes out his WBC's, could destroy antibodies for all we know - he should not have caught COVID a month after his booster dose unless he had a very poor immune response for whatever reason or he had just enough antibodies to fight it off at the time he was exposed - doesn't mean he'll have enough if he's exposed again. My sister is in the same spot - locked in her house - MS drugs wipe out her immune system too.
I talked to one of my PTs about an ER refusing to admit my brother because he was quarantined - of course that's nonsense, don't know why I didn't think of the simple answer - how could a person needing hospitalization for COVID (vaxxed or not) not get admitted when they showed up at the ER, assuming they hadn't been tested yet? (he never got tested)
Meanwhile, AMRN pps dropped under $4.00 today - POS stock - I don't think it went under $4 even after Du ruled against AMRN, meaning this is as bad as it's been since early 2018.
Semi-OT - FDA goes after n-acetyl cysteine DS for BS reasons.
I am so screwed it's not funny - NAC literally helps keep me alive - I've been taking it daily since 2006. The ONLY reason the FDA suddenly moved on NAC because in the article below it mentions many alternative medical treatments for COVID have NAC near the top of the list (it's been mentioned on this board before) - this is all political BS. I just spent a small fortune buying a couple year's worth of NAC on eBay, the same brands I've taken before - after they run out, I'm in big trouble unless the FDA reverses course.
We're well aware of the FDA's sometimes ambiguous decisions of what is a drug and what is a supplement - icosapent ethyl (IPE) is modified EPA distilled from fish oil, which automatically makes it a drug (doesn't exist in that form in nature, see more about this below) - AMRN sued the ITC to ban the import of DS containing pure IP and they punted to the FDA, which said "we're not going to make a decision in this case", despite the fact that their own regs spell out in black and white that IPE is absolutely a drug. The DS warning letters usually only go to websites making medical claims, and all the need to do is remove the claims from the ads and they're still allowed to sell the DS - but this time, with the FDA going after Amazon and apparently Vitacost, they've really choked off the supply.
I know of at least one DS that was turned into an FDA drug, the reverse case (also impossible according to FDA regs) - methylated B-12 (comes in 3 forms) - some company did drug trials and found that a high dose could be effective at treating childhood autism, got approval to make it a drug (Deplin), but somehow made a deal with the DS industry that DS could still sell it but only at extremely low doses - like 1-3 micrograms - I take two of those per day too. Bottom line is FDA can do whatever the hell they want because nothing is a law, they're all non-binding "guidelines" - only when it's a scheduled drug and the DEA gets involved do real laws come into play.
From:
https://holisticprimarycare.net/site/news/fda-amazon-nix-nac-in-dietary-supplements/
I talked to him yesterday - my little brother had a heart attack while mowing the lawn and was taken to the hospital in an ambulance, had just gotten two stents, needs a third but he must have been under too long or something, they couldn't get it done, having it done today or tomorrow. Even worse, since he's not vaccinated (he wrongly believes he caught it in Jan 2020, literally impossible, only a few hundred cases at the time in the US, all at major international travel cities), he cannot return to the hospital until he passes a 10 day quarantine once he goes home - hard to believe, but I think that means if he has another MI they won't admit him - at least that's what my Dad said. Maybe one of the ER docs here will read this and chime in on whether that's even legal (in theory ERs cannot legally refuse any patient who shows up), and what their hospital policies are for situations like this.
Now that's every male in my family with CVD except me, two with MI's and the 3rd barely avoided one - I believe thanks to me playing aerobic sports all year round up until age 43, a decent diet, and Vascepa, plus the vast amount of medical care I've gotten since 2005 - I get poked and prodded by various talented PTs several times a week and get blood/urine tests at least once a year - no other male in my family exercised at all during their lives except for my older brother walking a couple miles/day after he'd already been stented. Can't discount the host of antioxidants and other supportive DS I have taken daily for 15 yrs either - my bro ate like crap, had a horrible family life (should have been divorced 20 yrs ago, won't because he'll lose his daughter), and likely has had a major depressive disorder for years too - lots of stress and no way to release it. Each of my PT sessions involves a little mental therapy too - talking about what's bothering you helps point them in the direction they need to go, as many physical problems are actually manifestations of mental or nervous system stresses.
While talking to my Dad, he told me he's actually tested positive for COVID within the last 3 weeks - results of ELISA tests that measure IgG and IgM antibody levels, the same kind of viral tests I get annually. Doesn't say 100% he has an active infection, but if you're positive for IgG it means you're recently been infected - IgM will be positive your entire life once you've had a infection, says nothing about your current status. Couldn't get him to say he'd gotten confirmation via a PCR test, he wasn't exactly thinking straight (can't blame him) - he said he's never had any symptoms, and his recent vaccine antibody level tests showed his were down to 40, very low. It's like the Virgin Mary - how the hell did he get infected when he's locked in his house except for doctor/hospital trips for his cardio/oncology checkups and IVs, plus the grocery store where he's masked wearing gloves? I think he got it at a medical facility, hard as that is to believe.
In any case, he's alive, thank god, must have caught Delta and survived it w/o even getting the sniffles. He said when PFE's new antiviral drug combo gets EUA his house will be open to the family again - praying that happens before Xmas but I don't think the FDA will move that fast.
Thanks for asking and listening - these posts have helped me keep my head on straight through this difficult time.
IIRC the USPTO initially rejected a certain patent, AMRN appealed and used Kura as a reference to prove their point (JL pointed this out, I believe), and the patent was then granted - how could this not have come up in the trial? Du was wrong on both counts - that the POSA didn't look at Kura, and if they did they would have found the patent obvious.
Not under GAAP acounting they're not - those damned options and RSUs put them in the red again - they'd have positive EPS for the last two years if not for those handouts.
AFAIK he goes to the grocery store masked up but otherwise pretty much locks himself in his house - it's not a life I'd want to have, it's just surviving, not living. What I really don't understand is the level of fear - we're all gonna die someday of something - maybe the fear is of suffering in the hospital for weeks? He's seen both of my grandpa's plus his wife die from cancer with their last days almost comatose in the hospital - no plugs to pull, they were just there waiting to die***. I'm not even sure I want to see 90 like him, with all the abuse my body has taken over the years I'd probably be incapable of doing anything physical - just near 60 some things are getting difficult.
*** Reason some old people refuse to go to the hospital, basis for an old joke - "everyone I know who goes to the hospital dies, therefore the hospital is killing them, so I'm not going, I'll never get out alive".
Delta has been around since June/July, that's not what scared him - something new he learned or was warned about by that family friend is what changed his attitude literally overnight. Hard to respect someone you love when they tell you "I don't want to see you" - and he doesn't call either (ever), if we talk it's because I called him. I didn't just lose him, I lost access to my entire family, gatherings at his house was the only time we got to see each other, and I live way too far away from everyone to drive up there for a short time then turn around and drive home.
He certainly doesn't watch TV news, he reads the local newspaper on his Chromebook every morning, so he's not listening to those idiot talking heads on TV. He's not going to live the rest of his life with his family around him - he's pushing us away and there's not a damn thing we can do about it. I just don't understand the mindset.