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Thanks again STS, just now got caught up reading the latest AMRN posts.
Thanks STS, I appreciate your effort. Hope the doc gets some sleep before he next responds....LOL
Thanks STS, Vascepa has been almost miraculous for me in reducing Gastro Intestinal stress, without even a mention of all the other ++++s!
On this subject, I've been preaching to the choir (including AMRN) since we were shot down at the AdCom. But honestly, I was just as surprised by the action as everyone else. I didn't think they had the requisite set.
Quite honestly, a few years ago I wouldn't have taken it seriously either. Times are changing.
Well, regardless of Pharma & Medtech Business Intelligence' take on Amarin's 1st amendment lawsuit against the FDA, sometimes you just have to go for it. I believe AMRN has been pretty clear that this filing is not an altruistic effort, degrading the FDA's authority is not the thrust of this suit. AMRN is taking an offensive stance against an agency, the FDA, that has deliberately injured them, almost fatally. If you read the filing papers, it's clear that AMRN is now fighting to finally get the truth out, THE WHOLE TRUTH, and it isn't pretty for the FDA.
I hope you're right JL but I disagree with you on one point......I don't feel the slightest bit sorry for what I hope is going to happen to the FDA.
STS, I'm definitely interested!
STS, does your Cardiologist or other specialist write the lab orders for you. I guess what I want to know is how are your orders written, special diagnostic codes for conditions you suffer from, etc.? I'd like to get some of these tests run as well but Docs are reluctant to write the orders!
All I can say is it's about f..king time!!!! Thank God they've finally grown a set!!!!
Here's an interesting 1st Amendment Rights development:
MRK:
"FDA to hold public meeting on off-label drug promotion" • 11:13 AM
Douglas W. House, SA News Ed...
"Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies."
I completely support any action on the part of Amarin that legitimately exercises their 1st Amendment rights, but unfortunately they haven't shown any desire to step outside of their box.
You must be wearing your special Superman X-ray Vision glasses Zip, if you see light at the end of the tunnel. What I see is a company that needs to keep doing what it's been doing.....grow the franchise. But they also need to kick the Vascepa Story up a notch and put it out in front of the public and the Docs! If they tell a story backed up by facts, then they need to rely on 1st Amendment Rights and GO FOR IT!
The problem as I see it is that FDA will not approve an expansion of Vascepa label until some time in 2019. This is completely unacceptable, but what can we, as investors, and Amarin do to get around the FDA? I know the answer, but does the company have the resolve to do it. 1st Amendment challenge.
The problem as I see it is that FDA will not approve an expansion of Vascepa label until some time in 2019. This is completely unacceptable, but what can we, as investors, and Amarin do to get around the FDA? I know the answer, but does the company have the resolve to do it. 1st Amendment challenge.
There's a nice positive here...refills for the week had a nice bump! That's important, just as much as new users! (OK, not quite as much.)
Senate and HR Email Addresses - Got a problem with my regular PC, working from old one w/o networking. Anyone got most current Email Address Listing - search is getting me a lot of third party lists. THANKS!!
Nope, that's not correct......see my post #47727.
Thanks HD, I'm familiar with this list. I'm looking for the whole Medicare Package and wondering if any others on the board from NJ have found any particularly solid plan combinations including Vascepa (+ the other 7 RXs I take every day - lol).
Hi Dude, not sure I'm 100% on board with your description of pharmacy role. My Drug Benefits Manager is CVS. I was notified that in 2015, Vascepa would no longer be covered but that Lovaza was equivalent drug for the indication.
My Cardio prescribed V as he had done in 2014 but CVS called and said V was not covered use L instead. In addition, I could save some money with generic L. If I wanted V, I could pay full price (less coupon) or get Pre-Auth from Cardio. If I hadn't balked, I'm sure CVS would have filled the script with gen L.
Cardio wilted in face of UnitedHealthCare, said it was HARD (whine) to get Pre-Auth, use L or pay full price for V. Tried to tell CVS and Cardio that L was inferior to V. CVS and Cardio both told me not so, SAME INDICATIONS......that's the problem.
BTW, I'll be losing the Cardio (my choice) but also losing CVS (not really my choice). Going off employer coverage (secondary to Medicare) and onto Medicare Advantage Plan or to Medi-Gap and 3rd-Party PartD. Anyone find a great plan combo in NJ?
I completely agree Zu and I know you're a strong AMRN long, just can't believe how shallow some of these authors can be......and they still get published!
Pretty pictures.....bullshit article. Zum, I believe your decision to post this article satisfies any obligation on your part to provide "fair and unbiased" reporting. OK?...now no more crap from idiots.....even with pretty pictures! (Thanks for all your effort, Zum) ;>)
At this stage of the science, why would anyone bother to fund a "study" that doesn't take dosage into account? These participants were probably taking at best 200-500 mg of EPA and/or DHA daily. That amount added to statin therapy at almost any strength would only show minimal additional benefit. It is so frustrating to see "experts" publishing bullshit results like these and usually this is the drama that gets picked up and distributed by the media.
Interesting how the pricing quoted ($1.10) as TITXF fair value and also as correction target coincides with price mentioned by HC777 as his desirable re-entry point.......
I, along with many others, will be looking forward to your sage advice in 5 months!
HD is being a BB. (not to be confused with our other BB)
Post #47287 from BB, did not do my own DD on this one.
As regards the Court Cases - it is quite disturbing to me that the judge was scheduled to rule on two motions this past Monday but nothing has materialized and no updates have been posted. With the incredible number of malevolent actions taken against this company, I can't help but wonder if there isn't one more waiting around the corner! The least they could do is throw us some crumbs!
I'm paying $158 and change at NJ CVS with no insurance coverage 30 day supply with V discount coupon.
And the disclaimer would be placed at the bottom of the claims where nobody bothers to read it.
There is no way FDA can make a legitimate argument out of fear for their image. There was no new science that determined that lower tryglycerides were NOT beneficial for cardiac health. They could easily have maintained the status quo especially with a drug as benevolent as V and with no Hazard Risk. Instead out of fear that Vascepa would become a game changer, they decided that they would make that as difficult as possible for Amarin to achieve. They chose to ignore all the positives and for that they will someday have to answer....like Coleman already has - RIP.
Unfortunately no, this was an employer plan and in 2013 and 2014, V was covered. Coverage was dropped for 2015, no longer in formulary....but I can have Lovaza generic! (I'd rather have a stroke).
BioC it is very strange. I am paying $158.85 for 30 day supply using V discount but no insurance coverage. I was quoted $600.00 and change under same scenario for 90 day supply. My prescription manager is Caremark under Bank of New York/Mellon.
And I think that anyone who takes you seriously is being overtly influenced by the sound of your posting ID! Give it a BREAK!
Why the hell is this crap being posted here? Seven years ago they didn't believe the world is ROUND!
I'm pretty certain that I'll be giving up on ever expecting to understand what makes AMRN tick! I can't recall in 40 years of trading seeing another stock that rivals AMRN for it's lack of predictability. Think I'll go to bed now.
Just don't bet anything of value on that and you'll be good, marzan!
Take whatever measures you can to have Vascepa prescribed for your father. It holds the possibility of providing some cognitive benefits but it will definitely act to lessen the effect that atherosclerosis has had on his health. 4 gms daily should reduce chronic inflammation to protect the endothelial lining of his arteries and stop plaque buildup, help to stabilize and possibly even shrink existing plaques to increase lumen diameter and improve circulation, and lower the risk of future strokes or MIs due to ischemic events.
If your taking a flyer on a stock investment, you couldn't pick a better time or a better target than Amarin.....just remember, it may turn out to be a flyer. As an aside, if you have any family or friends with any kind of heart issues or diabetes, find a doctor to prescribe Vascepa for them, it could very well be a life saver.
Rawnoc, you were always my favorite (i.e. right after New Money)!
Hey NewMoney, you got any kind of stake in Amarin? I'm relegated to buying Call Options from Mo to Mo or Qtr to Qtr......the only way I can get the leverage needed to recoup my losses. I think maybe we're finally at an inflection point.....where events will again drive the PPS and the FDA has diminishing relevance. Nice to see you're still around....good luck!