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Wow. So EMA pushed back? They've been sitting on it for such a long time, and there is so much information available, what more do they need to know? it's mind-numbing how AMRN continues to get screwed by incompetence (both external and internal) at almost every turn. Truly unbelievable. Guess I'll sit it out till EMA meeting...
Been away. What's latest EMA update? I've been away from AMRN for awhile and looking to maybe get back in. Would someone be kind enough to give me update on EMA approval status? Someone on ST said it's listed in "outstanding issues" section, which they believe means 3 more months. Would greatly appreciate this board's status opinion. Thanks very much for any help.
S1P1 receptor agonists for “cytokine storm.” Might be a viable option to reduce ARDS and need for ventilator. Two existing MS drugs might be worth trying: Gilenya (fingolimod) and just-approved Zeposia (Ozanimod), which may have better safety profile. New trial starting in China with fingolimod. It’s immunomodulator, not immunosuppressor, so reduced risk of secondary infection, but still a risk. However, if the alternative is ventilator with 86% mortality, I might prefer to risk it and fight secondary infection. The drugs are not cheap, but would likely only need few days treatment. Perhaps your friend in NO might want to consider this (PS, some older anecdotal evidence from Ebola front suggests that statins and ARBs (preferably in combo) have shown efficacy)
https://www.sciencedaily.com/releases/2014/02/140227142250.htm
Doc, what about the potential of currently available MS drugs like Gilenya and just-approved Zeposia? Both are S1P1 receptor agonists that supposedly have a marked ability to reduce cytokine storm, which is a major cause of ARDS. No one is talking about this (only il-6 inhibitors), yet it could be an excellent option to try since it is FDA approved with a known safety profile. If I’m in NYC (or Italy, Spain, etc) I’m looking for anything that can help reduce mortality (as well as reduce need for ventilators, ICUs, etc). Can’t we “trial under fire” now?
HELP Spam popups here have become incessant. I can’t read one or two posts before yet another “You’ve Won a Prize” pops up and prevents me from continuing. Have pop up and ad/content blocker on but can’t stop this nonsense. Any suggestions?
JesseLivermore: This 2014 article says flu “cytokine storm” can be mitigated by drug that activate S1P1 receptors to dampen immune cell over-response. The drug (Ozanimod) was licensed to Receptos, who was bought by Celgene (now BMY), and awaiting FDA appvl for MS. Why not this for c-virus?
https://www.sciencedaily.com/releases/2014/02/140227142250.htm
Sharing some investment ideas: while we wait, thought I’d share some interesting plays:
IOTS:This is a 7% (14% annualized) arbitrage play available right now. IOTS (Adesto) being acquired by Dialog for 12.55 ps, but c-virus has just knocked price down to 11.64. Make 91 cents by September deal close. No reason to think deal won’t close as It’s a great fit for Dialog and IOTS is a strong company on its own in a great growth space, so you wouldn’t mind owning it even if merger somehow fell through.
PAVM: very interesting medical device play, with numerous products, 2 just moving into commercialization with a strong pipeline. $100M market cap with its first products showing a $2B+ TAM. I never give credence to TAM, but rather prefer to see if a small but realistic percentage of TAM is achievable, and how that would impact cap. Considering how little of the TAM is necessary to blow up a $100M market cap, this is a bet I’m willing to make based on the product suite. For DD, check out several recent SA articles, and go to PAVmed website for investor presentation as well as latest 10Q. You should have good feel for the company based on this info. Interested to get opinions here as this iHub group is a great collection of some very smart people (and some characters too lol).
Dmiller, yes I wondered the same thing. I called and left message at Amarin last month, but missed their call back and didn’t followup. They subsequently sent me a letter and a fedex package to send it back to them but haven’t bothered yet.
(Oddly, your note below shows 2 replies but I only see one. Maybe someone has me blocked?)
Great work Hamoa! Very much appreciated
Sorry, but the premise that BP only wants to make big acquisitions within the first 6 weeks of a given calendar year is absolutely idiotic.
Orange, agree with you on KOLs and govt influence, and along with EU negative stance on fish oil supplements, think this bodes very well for Europe revenue potential. Only potential negative is that EU is a bit more leery about overprescribing statins, so that may tamp rev a bit (assuming V label will be as adjunct to statin)
Been through many (latest just few days ago when IOTS got bought) but simply sold my shares or options when the BO was announced and share price soared. Never hung around long enough to be in position to vote, or to participate in any voting process. Closest may have been the MDVN because it was originally a hostile takeover so there was a request by the bidder to pledge shares, but again I just had options so didn’t participate.
“In a worst case scenario of Vascepa losing exclusivity immediately, we believe pricing would be almost 100% maintained,” Beatty argued.
I believe he made this supposition based on V compared to the price of generic Lovaza. If true, he’s an idiot. Regardless, there is no way the initial reaction to patent loss would be negligible.
Hey bUrRpPPP, PAVM is flying. Took small position. What’s your thinking on this? Seems like a significant risk/reward play.
CITI: even with patent loss, price should stay same!!! Can someone explain his logic here? Given the fight here over whether AMRN can compete with generics price-wise, how does he justify this comment?
However, while she can’t guarantee how decision will go, with the “grasping at straws” comment, sounds like she believes good chance of Amarin victory, no?
Sharinsky, if that is in fact Boeing’s preventive maintenance list, that is by far and away the most extensive list I’ve ever seen, and may be simply a reflection of Boeing’s largesse. I’ve checked several plans, including Aetna, UHC, and numerousBCBS plans, and have not seen anywhere close to this many drugs listed, and never Vascepa. Look, I am very long, and would love for V to make every maintenance drug list so cost is taken out of the equation. I just doubt that it will happen any time soon. However, I’d LOVE to be wrong here
Sharinsky, if V ever gets preventive maintenance status, we will have hit the jackpot! Not happening anytime soon though, and probably only when patent runs out and cheap generics become available. Nice thought though :)
Ha, but taking two would make me run out before next available refill, no? In any event, that was not my plan (my plan doesn’t cover ator at all as prev maint status), was just showing it as example. So what did you do that required explaining these benefits? Dr, Pharmacist, HR?
Lido, the bigger issue is BCBS is not one platform. RMF is correct, but beyond the high deductible plan is the fact that there are dozens of individual BCBS entities, and each has a somewhat different formulary (and some have different formularies for their bigger clients, like my company which has 30k+ employees), so I don’t think we can generalize across all BCBS platforms. Regarding preventive maintenance status, that also differs by BCBS plan, but understand that there are very few meaningful/costly drugs afforded this “no cost” status. In fact, BCBS of Michigan lists some statins under preventative maintenance, including atorvastatin, but only at 20mg or under! I take 40mg, so I would be out of luck under that plan, and I’m totally out of luck under my BCBS of Illinois plan as they don’t include atorvastain at all, even though they include other statins. This illogical inconsistency is some crazy bullshit and screams for a major overhaul of our pharmacy benefit system. In any event, sorry for the rant, but this is how it works.
Relocatedmetsfan, yes, savings card applied. In fact, at the same time I got my text notification from Walgreens that my Rx was ready, I got a notification from Vascepa saying I saved $450!
That is a bizarre story. Not sure it implies anything more than simple incompetence, but an interesting story nonetheless. On the assumption that a BP sales force would be significantly more competent than what this and other recent AMRN rep stories suggest,I say GO BO! :)
Re BCBS, just got renewal and this was first time it was filled immediately and not delayed/referred back. I’m with BCBS of Illinois. Not happy it’s going to cost me $500 for 3 mth supply, but I’m in high deductible plan so it is what it is.
KC, think someone said up 76% Jan YOY? What I think we really want to see by Q4 is a 1B+ runrate going forward. Not so concerned about actual 2020 numbers if the trajectory increases at backend foretelling Billion+ 2021.
Ugh. $518 for 3mth supply of V. But Amarin sent me text saying I saved >$450 lol! Using BCBS of Illinois. No wonder there’s such a dip in Rx during new deductible season. :(
Believe BB owns >10% , which I think makes them insider needing to report transactions within 2 days. They hold 41M shares, against 358M outstanding (not including convertible and restriicted shares that bring total to 400M or so). Think this is correct but not 100% certain (not that it matters, cuz there is no way BB divested any major chunk of their AMRN holdings)
CBB The Euro rev # certainly adds another de-risking perspective to the AMRN investment thesis. If the numbers HDG suggests for per patient rev are combined with the potential market penetration, don’t see much downside. My problem (and probably many others) will be that I’m already fully loaded in AMRN and will have to dig up new cash if the post patent case big dip opportunity materializes. In any case, the Europe rev potential makes me feel better and will soften the blow if we lose the patent case.
G, if I’m understanding your numbers, it would appear that even at your lowest estimate of $1200/680, a BO at or slightly above the current market cap could be justified by just Europe market peak rev. Assumption is that EU/all Europe population is 500M/750M, so not impossible to grab at least 4-5M V patients. So if AMRN loses patent case, an interesting stock play could emerge: the share price will undoubtedly dive, and in these type scenarios, typically well below a rationale bottom. Buying this massive drop would likely afford a pretty nice round trip back to (or at least near) current price once market reevaluates and realizes Europe potential (not to mention Asia) and more important, the remaining BO potential (as you identify in your post). I still wonder what, if any, US revenue potential would remain, or is there no chance to compete with the generic makers?
What if Generics win? How does AMRN compete? Since we’re waiting on pins and needles for the trial to end and a decision rendered, I thought I’d throw out an interesting hypothetical question to our illustrious board of experts: what does the financial picture look like for AMRN if they actually lose the case and generics are free to produce V? Can (or does) AMRN price V as cheaply as a Hikma/Reddy? What might that price be (assume Hikma/Reddy manufacturing costs will be same, no?)? Can AMRN lock up enough supply to impact generic production costs? What benefit (other than label) can AMRN/V offer that generic makers cannot match? Ultimately, how much of the market can/will AMRN capture, and what would their rev/profit picture look like (and market cap/share price)?
Let’s stir the pot. Thoughts?
Oh, I’m totally there with you. I spent a lot of time at ipwatchdog site and other research sites and my head was absolutely spinning. I did get better educated on direct infringement, induced infringement, Hatch-Waxman (talk about a conflicted doctrine, dear Lord what a mess that piece of legislation has created), etc., but all it really did was create more anxiety as it’s clear that nothing is clear, and anyone who thinks this is a clear cut win/lose has no idea or real-world experience. Those who make such unequivocal and definitive statements pretending to fully understand how this will play out by citing a case or two they researched online, are simply fooling themselves. What does seem to be consistent is actually the inconsistency of each case relying on a particular judges interpretation based on their own predilections, and the inconsistency inherent in Hatch-Waxman, which allows for some leeway based on a balance between encouraging drug innovation and opening pathways for generics. In any event, I’m hanging in with an all-in bet, relying on the court impressions from firsthand attendees,and drinking a lot of wine (sometimes as I gaze out my office window in lower Manhattan wondering WTF am I doing lol!?!?)
TTE, besides being Harvard undergrad and law school, Sipes was awarded the Justice for Victims of Crime Award by the U.S. Department of Justice for work done on behalf of hate crime victims, and is also pro bono leading a challenge to the exclusion of woman from combat by the US Army. Hopefully this suggests that he has a conscience and displays a respectful/professional demeanor that plays well with her Honor the judge (who is the only one in the room he needs to impress and not disgust)
HDG, I’m out of action rest of day so will try to respond tmw on both buy criteria and also the original question of whether share price affects BO negotiations. Have a good day(or night)
HDG, I greatly respect your contributions, and I agree with most of what you say. However, your statement was so definitive that it took me by surprise. I did know your background, which I thought was something like middle mgmt in media in Eastern Europe. So when you said you know for sure, I thought I must be mistaken and you had some definitive highly relevant experience that I was unaware of. With the utmost respect, I disagree with your 100% sure notion that share price doesn’t affect a BO negotiation, and that your experience qualifies you to make such a definitive judgement. I also strongly disagree that biotech valuation/acquisition decision criteria are the same as any other industry. In my humble opinion, based on decades of Fortune 200 business experience, biotech investing, as well as contacts within the investment banking community, valuations and buy criteria absolutely differ by industry, and even from deal to deal. I assume it’s best we simply agree to disagree. I certainly value your opinion and will continue to look forward to your posts. I will also not be afraid to challenge notions that I may not agree with. Cheers.
Clearly, on both counts. I have great respect for many on this board, including HDG
Sts66, off memory, the study (which I think HDGabor may have recently posted) said that there were perhaps 80M Americans who were statin eligible, but only 50% were actually taking statins. The interesting part of the article was that, beyond the obvious reasons of denial, cost, etc, a large % simply are not aware of, or have not been made aware of, the benefits. Shocking but true accordingly to the article.
Chas, thanks for the nice note, which follows on the info JL provided yesterday. Although I’m keeping my expectations conservative, i’d be overjoyed to see V freely prescribed regardless of statin use :)