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If ISIS manages to kill more Marines and civilians near the Kabul airport nothing that is released at the ESC over the weekend will crack the headlines of MSM. So far 12 Marines dead - horrible, and I doubt it gets better before 8/31 when the pullout is supposed to be done.
I've mentioned that before - I don't believe a 2 g cap is feasible, would choke a horse - the OTC Epadel (and maybe even the Rx version) sold in Japan is contained in packets, with hundreds of little balls of EPA inside them - I could see taking 2 g at once via that method. I think the whole thing may be a moot point - not sure AMRN gains anything if they try to get that approved in the US, generics could still steal R-IT scrips.
Dodd-Frank is a good example of how a BP would not have been trampled in court like AMRN was - big banks/brokers (more powerful than even BP) have successfully lobbied to get many of those rules revoked, we're almost back to where we were before the financial crisis, regulation-wise.
In this day and age nobody has complained about her anti-American attitude and tried to get her fired? Or at least started a campaign on FB to have her removed? I knew a fellow lymie who was a refugee/boat escapee from Vietnam, and it scarred her horribly - some of her family still is stuck there. From what she told me most of the ones that made it to the US were mentally scarred from the NVA taking over the country and sending off many educated people to camps or outright killing them.
That *is* a case study that was posted here months ago, just a different version of the story - I believe the term shock is used as in "septic shock", which is what can happen when a person develops severe COVID.
After googling some stuff BMS/PFE lost "data protection" on 6/16/2020, but have another two years of protection from generics, then patents must be overturned - this is almost identical to the EU's exclusivity regs, except EU uses 8+1+1, not 6+2:
https://gowlingwlg.com/en/insights-resources/articles/2019/innovative-drugs-data-protection-in-canada/
Seriously? Have you not followed the last year and a half of the implications of Du's decision? How generics skirt around skinny labels? That Teva/Apotex can enter the market in 2029? That you can't protect the exact same molecule/drug past patent expirations even with a new indication?
Is PFE really going to retain those reps just to promote V? They won't earn enough to cover their keep.
AMRN finds JK replacement, a "Jason Marks" - don't know anything about him:
https://investor.amarincorp.com/node/21201/html
Shades of MRC emerge as another biotech is attacked - a whistleblower claim has been filed against AZ drug biotech SAVA, saying they a guilty of scientific misconduct, mentions they're in the same league with the Theranos scandal. Stock cratered last night AH and today, from almost $120 to $80 on huge volume. I've been reading the CP filed with FDA asking them to halt the coming P3 trial and SAVA's almost instant rebuttal released this morning, they must have worked all night on this (no silence from them, whereas AMRN never confronted MRC). Don't know what to think - appears to be a short attack disguised as a whistleblower suit. Links to the CP and other docs:
https://www.regulations.gov/docket/FDA-2021-P-0930/document
Whaddya know - our old enemy AF is involved too:
https://www.statnews.com/2021/07/30/alzheimers-scientists-critique-cassava-sciences-study-results-overblown-inappropriate-uninterpretable/
Initial SA news blurb this morning:
https://seekingalpha.com/news/3733865-cassava-sciences-falls-on-concerns-over-alzheimers-trial?mail_subject=sava-cassava-sciences-falls-on-concerns-over-alzheimer-s-trial&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha
SAVA rebuttal to the claims:
https://seekingalpha.com/pr/18448165-cassava-sciences-responds-to-allegations
Hadn't invested in this yet, now not sure what to do - is this a buying opportunity or a real problem for SAVA? I've owned other bios where clear short attacks turned out to be correct, like NAVB and Marty Shkreli - MRC failed with AMRN, but a different situation, drug was already approved there. The cynic within me says like AMRN/Nissen, somebody big is behind this attack on SAVA - plenty of BPs working on AZ drugs.
I think the point about a biotech like AMRN at this point in it's life rarely being BO is accurate - a one drug company with stagnant US sales - time to BO was right before or right after R-IT results, but JT wasn't willing to listen to offers - even when they were addressing EU sales he said they weren't looking for a BO, they were looking for a partner. After the Dubacle there's even less reason for a BO - where have you ever seen a BO where generic competition existed in the US?
If Elizabeth Shue is in a movie it's worth watching, period! What cold fusion breakthrough are you referring to? I was just looking up the history of the cold fusion scam yesterday to provide commentary to a SA article - it was widely debunked and quickly - if something new has come to light I'd love to see it, didn't see anything like that while I was googling for info.
An otherwise great article ruined by this statement:
All of those name changes occurred at least a decade ago, some several decades - the FDA has revised guidance since then to avoid the exact problem you mention with Losec/Lasix - they will not let you name a drug that sounds like any existing one - that's part of the reason why drug names are becoming more bizarre over time, they're literally running out of unique names that have no resemblance to existing ones
PFE only has 60 sales reps in Canada - not exactly going to blanket the country.
Exactly right Capn - and furthermore, generics still have to defeat the patents after exclusivity expires - AMRN has patent protection in the EU thru 2035 IIRC, and JT stated that they may be able to extend it all the way to 2039. EU will not see generic V for a very long time - the actual protection will be a min of 13 yrs if you assume generics try to overturn patents in 2031 and the case plus appeals takes at least 3 yrs.
Section 2.1.3 does not mean AMRN had any involvement in the HLS/PFE deal - co-promotion is not the same as a sub-license, the latter is a deal where the licensee sells/distributes the physical product and retains all revenues. It's akin sub-letting an apt - if you can rent it to someone else for more than you are paying the owner you get to pocket the diff - assuming the lease doesn't prevent sub-letting, of course.. Someone posted an example of a biotech doing this a few days ago - they licensed a drug to develop from a BP for low single digit royalties if it ever got approved (prostate cancer drug), then they subsequently partnered with another BP after successful trials in which they would share profits at 50:50 plus milestone payments - the BP that gave them the initial license isn't entitled to any more than the original royalty rate.
Yup, utter nonsense - somebody needs to stop posting garbage here after he gets his drink on.
All this talk of AMRN abandoning the US is a ridiculous waste of time - it's not going to happen. And no, more API would not be available to generics, AMRN would still have their suppliers locked up for EU and ROW sales - China sales may start next year. Sleven is just stirring up shit our of boredom - "screw the US they don't respect our IP" - no consideration is given for the hundreds of thousands of people, including many on this board, who take V to help reduce their CVD risk, and the million+ who SHOULD be taking V to help save their lives.
Lot of people going to be in an uproar if FDA approves PFE vaccine tomorrow as expected - that's only 3 1/2 months after PFE submitted the BLA - a very rushed process. V as a CV19 therapeutic has a long way to go, P-IT2 results won't be out for a few months, and even if it is shown to work that doesn't mean countries are going to allow V to be sold there absent formal approval for any indication.
Looks like competition for RLFTF/NRXP inhaled Aviptadil, has a different MOA but does the same thing, calms the cytokine storm that destroys lung tissues. No way to bet on that drug though, not made and tested by a publicly traded company, but the results appear to blow away those from the IV version of RLF-100, although that drug was tested in people already on O2 therapy or vents - much sicker patients.
You can't change the name of your drug after the FDA approves the NDA, except when the drug is modified to act differently, like an extended release version, and you put a suffix on the end of the existing name - Wellbutrin XL, for instance (the drug where generic was determined to not be equivalent to brand), or Adderall XR. Can't change the label to remove the TG's > 500 indication either, that's still a valid use of V and accounts for ~ 10% of sales. That's why V is protected from generic attacks in the EU - V is not approved there for TGs >500, indication is not on the label.
I see what you're saying - the LTCG tax rate literally disappears if that proposal passes (no chance in hell), and your taxes will be based on the ordinary income tax brackets - I was thinking the LTCG rate would still exist, but be increased as high as 39% - but same affect for the two different tax laws, doesn't really matter which one applies. If they actually try to impose that rate for earnings/cap gains > $400k, which IIRC is the current proposal (married or single?), there is literally zero chance it passes - even if they raise the limit to $1M I doubt it passes with a max 39% rate - remember, Congress would be imposing those taxes on itself too.
Yikes! I had absolutely no idea LTCG's affected your MAGI (have never had that problem), which in turn affects your Medicare premiums - affects Part A/B significantly, but also can raise your Part D premiums too, like by up to +$75/mo on top of your current premium. This can get really confusing - the rise in premiums doesn't occur until two years after you had those cap gains, and as you worry I'd bet when the 3rd year starts and your income is back under the MAGI limits the SSA doesn't immediately lower your premium back to normal, you probably have to contact them and bitch to get them to change it - good luck with getting in touch with a real human at the SSA!
BTW, from another post of yours:
How is it helping Nissen? It's certainly not helping patients who could benefit from V - I don't care if MO is inert or not (FDA didn't care either) - there's no way in hell R-IT and EVAP results are invalidated by using MO for the placebo, the magnitude of the improvements is way too large for that.
AZN should be smart enough to know that V is not a cholesterol drug, it's really not even a TG drug when it comes to R-IT results, so IMO they're not direct competitors - V is not a competitor to Repatha, for instance - you don't see researchers contracted by Amgen going out of their way to torpedo V and R-IT like you do with AZN/Nissen.
Did anyone send that study to IR and ask for a rebuttal? AMRN may not even be aware of it - lettruthringout has an uncanny knack for digging up stuff nobody else here finds - he must have some sort of system for scanning the net for anything related to V and IPE.
Good thing you're aware of it in your position. Just thought of another way to describe this - for dog fans, Caesar Millan has a new TV show, "Cesar Millan: Better Human Better Dog", airs on Friday nights on NatGeo at 9:00, two new episodes every week. I've watched every TV show he's ever had, at least 3 different series, and that man is a god when it comes to working with dogs and humans - he understood the energy stuff since he was a kid walking dogs for a living. If you've ever seen him in action, half the time he doesn't even have to say a word or make a movement to control an unruly dog - he just uses his "I'm powerful and in control here" energy to influence the dog - animals pick up on our energy extremely well, they really do know if you're sad even if you're not crying or anything. Also know if you're weak, that's when they take control as "leader of the pack", because every pack needs an Alpha dog. Funny story about dog/human energy exchanges - years ago I started dating a nice but messed up from a really crappy marriage/divorce gal - she shared custody with her ex of their two adorable miniature schnauzers. Before I went to her house the first time she warned me to watch out for the dogs, as they "didn't like men" - I told her not to worry, I loved dogs and they loved me - sure enough, when she opened the door those two dogs instantly jumped up onto my lap (I was kneeling to greet them) and started licking my face like I was their long lost "Dad". Hilarious - her jaw actually dropped, she couldn't believe what she was seeing. I didn't say it, but in my head I was thinking "it's not that they don't like men, YOU don't like men!", and they picked up her negative energy - a real shame that assh*le she married scarred her for life, couldn't get over the mental abuse even after therapy. All animals communicate with energy (animal to animal and animal to human) - cats do it just as obviously as dogs, they make it real clear how they feel if you know how to read them - you need a bit of understanding of their body language to interpret exactly what they're trying to tell you, same with dogs. Now that I think of Caesar again, he uses body language too - when he's in take-charge mode he stands tall, chest out, shoulders straight, head held high - dogs (and humans) can read that posture, they know what it means - same goes for slumped over head down postures, it's a clear sign of weakness.
Nope - cap gains are NOT earned income - you have to work, be paid wages, and be issued a W-2 to have earned income - trust me, I haven't had a dime of it since 2007 (disability benefits are non-taxable), and because of that I cannot contribute to my IRAs, need earned income for that too. It's crippling to not be able to put money in an IRA at age 44, any extra cash has to go into taxable brokerage accounts. Luckily/unfortunately I haven't had any LTCG's that exceeded the basic deduction so I haven't paid taxes since 2007 either - but if AMRN eventually gets to a certain pps I might owe taxes when I sell - still have a significant amount of unclaimed capital losses to use, 3 stocks I had in my cash account that went BK, but they're still on TDA's books, instead of a symbol they're listed with a series of numbers/letters. Been holding off on officially closing those positions for the big AMRN (or ARNA) profit, assuming I ever get there.
And how many people have the perfect life to be able to do that? You're talking about having excess post-tax money to use for whatever you want after bills are paid - for me that didn't happen until I was 39 yrs old, and I don't think I had an atypical life to that point - student loans, buying a house, getting married to a spendthrift wife (quickly divorced when debt problems came to a head). Only thing that might be unusual was I didn't get my first "real job" until age 30. Look at the national avg. savings rate or retirement account values - they're horrible - even if you narrow it to college graduates the avg. savings in 401(k)'s is only $120k.
This suggestion on how much to save from Fidelity is a cruel joke - I don't know ANYBODY who could have possibly met these goals and actually lived a life (you know, like raised a couple kids?), at least not where I live (NYC, SF, Boston etc. even worse) - look at what the avg. savings for 60+ yr olds is in the last paragraph:
You mean slashing corp tax rates from 35% down to 21% type giveaways? You know, the tax cut that was supposed to increase corporate spending and increase the GDP, but instead the corps kept the savings and gave it to shareholders as dividends or used it for stock buybacks?
You're retired - and assuming the wife is too, the only income (wages) you have is SS, which will never put you close to a high tax bracket, max annual payment per person is only $30k/yr.
The proposal right now is to tax LTCG's as ordinary income only if you have taxable earned income of $1M+ - I don't think anyone here has to worry about paying more than the current 20% cap gains rate - if I was making $1M a year in salary/wages I would not be wasting time on a stock MB because I'd have a financial advisor handling my investments, and I probably work my butt off to make that money, don't have time for stock DD unless I work in the financial biz - lazy people don't make $1M/yr.
Maybe they think nobody could possible be so incompetent as to have the greatest CVD drug of the last 25 yrs but have no ability to sell it, so there must be another problem holding down growth, and they want to know what it is and if they can improve sales. This is not just any random drug, it has some baggage holding it down - ties to "fish oil" CVOT failures, multiple claims that R-IT was affected by MO, patent loss in the US, and a history of patient non-compliance (they stop in 6 months). IOW it's not a plug'n'play drug for reps.
Tremendous idea! Can't believe nobody replied to it - in the last CC KM explicitly stated that they would partner for sales in the smaller EU countries instead of GIA - PFE may want those territories, won't cost them much since there's no DTC ads over there. Big question is what AMRN would accept as a royalty rate - I would like to think they wouldn't settle for the < 20% rates they got from HLS, but OTOH I don't see PFE settling for anything < 80% either. They'd have AMRN over a barrel because AMRN already admitted they will have to partner in those countries.
I don't call a $1B bond from PFE a big deal - and it's going to finance or refinance money the spent developing the vaccine with BNTX.- almost hard to believe PFE didn't just fund that from cash, but if they can borrow money for 1.75% for 10 yrs they win and the note holders lose - inflation will eat away every penny the holders receive.
That does not apply to PFE/HLS promoting V for COVID use in Canada, FDA guidelines don't matter, Canada's rules on off label promotion apply, whatever they are. Not sure even if FDA rules did matter P-IT results would fall under the old guidelines - note your link if from Feb 2014, before AMRN won the 1st A lawsuit, and this section is key why AMRN had to sue:
First impressions with people really are huge - you may not know it's going on if you're not into this stuff, but you are reading/feeling their energy (this is totally non-verbal communication), and that immediately leads to one of 3 outcomes: 1. Positive vibes - you instantly like them - all of my lifetime friends and nearly every serious g/f were like that, 2. neutral - no strong feeling either way, how they behave over time will determine your relationship, and 3. negative vibes - an instant feeling of dislike, and I've never had that change over time - even if they're otherwise likeable people and don't behave badly towards you, you just don't mesh with them energy-wise, and there's nothing you can do to change that.
So that same thing plays out when introduced to new foods and drinks, albeit w/o the energy exchange, but for me the reaction is just as strong - I either like it or I don't, and if it's the latter I won't try it again. It's like some of those over-engineered microbeers that are stuffed with all kinds of weird ingredients - you taste a gross one (most of them for me!), and you will never try it again. If that job interviewer poured you a cup of coffee w/o asking if you wanted it they behaved poorly - you never force a beverage on somebody, it's impolite. We were too poor to afford fresh veggies when I was a kid (canned Green Giant veggies are disgusting!), so I never tasted broccoli and asparagus until I was adult, was served them in a restaurant with some kind of special sauce, or steamed in balsamic vinegar (yummy!), so they were delicious the first time I ever ate them and became a fan for life. Heck, even my long held hatred of green beans changed the first time I was served fresh steamed ones, not even aware they were green beans because they looked nothing like the limp pale green mushy crap my parents tried to force feed me as a kid. Still don't like peas though, LOL.
We know one of Nissen's huge problems with R-IT was a large increase in hs-CRP in placebo group - like +36% over baseline - AMRN argued reversion to the mean and waved it off. Do mice have hs-CRP, and if so, why didn't Nissen and his cohorts measure it to prove whether MO actually was inflammatory in mice or not? The cynic in me says they did measure it but just didn't publish it because it didn't support their conclusion that MO is not inert and harms patients.
EVAPORATE is under attack as well - right before the ESC conf. too - this was published in the ESC's "European Heart Journal", equivalent to our AHA journal:
https://academic.oup.com/eurheartj/article/42/31/3023/6273098?login=true