Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
And anchor spa decision will be rescinded...lmao
JL, do you have a deductible? If I stay with my current Aetna plan (no deductible ) under Medicare, my monthly cost for V goes up from $47 (tier 3 company) to $120 ( tier 4 50% copay) in 2017. If I switch to express scripts, then I have $400 deductible, and tier 3 copay of $42
Rose, in the following description from the Medicare site, I don't see anything about a penalty regarding SEP
Special Enrollment Period (SEP) for the Working Aged and Working Disabled.
Individuals who do not enroll in Part B or premium Part A when first eligible because they were covered under a group health plan based on their own or a spouse's current employment (or the current employment of a family member, if disabled) may enroll during the SEP. The individual can enroll at any time while covered under the group health plan based on current employment, or during the 8-month period that begins the month the employment ends or the group health plan coverage ends, whichever comes first.
Maybe I'm misunderstanding your dilemma...
Rose, not sure if this helps, but I was told to enroll within two months of eligibility. If you are working and have private healthcare, you should enroll in part a as it's free, and you can forego part b if you are employed in a company of 25 or greater employees.
Filing of Baker Bros....http://whalewisdom.com/stock/amrn
Kiwi, I don't know if there is a difference in pricing for off label versus on label...I'm just going by Aetna drug formulary for 2017
HG, what percentage of Amarin patient are on Medicare best guess?
I do have an option to switch to a different plan...but with a high deductible in order to have V at tier 3.....but the problem still remains....higher out of pocket costs for V with those on fixed income and no help from Amarin...like savings card which is no good for Medicare patients.
For a company with one trick pony, and who knows how many of its customers on Medicare...I certainly see scripts and revenues being affected...not sure how they can forecast break even in 2017 in lieu of this.
Aetna from $47 to $120 month co pay for vascepa...result of tier 4 designation for 2017. This is brutal for a lot of people and Amarin me thinks...
BB is our board version of Don Quixote...he means well...but....
That's encouraging but based on the pps, that view doesn't seem to be shared amongst the medical and bp community otherwise it would be much higher....however it certainly works for me!
Whadaya expect? BB relies on tarot cards and palm readers....
Stop with the kool aid Jason...your predictions and declarations are not much different that the smell of flatulence...and I'm mean that in the sincerest way...
Would appear this stock will not see pre adcom levels which I seem to remember being around 7. Binary event...R-IT success or bust....
Yeah right...all you need is a surprise from management like an earnings miss or an FDA screw job and down she goes...
See how bad my DES is...I read 3 or 4 doses and after re reading i see you wrote after 3 or 4 days...
JL...off label script for me...no lipid issues...but plenty of joint pain which has improved significantly over time. Still gotta pop Celebrex now and then. But now that north is calling for 3-4 germs daily for DES has got me contemplating. At 65 I'm still playing the beautiful game...fútbol ...thus the joint pain. ??
Good thing I'm not in the trial....been on vascepa 2gm daily two years now...DES remains the same for me. Had to laugh at my eye clinic when they offered omega 3 gel caps for my dry eyes...
One word: Limbo
Any of the following describes our investment
2) a place or state of oblivion to which persons or things are regarded as being relegated when cast aside, forgotten, past, or out of date:
3)
an intermediate, transitional, or midway state or place.
4)
a place or state of imprisonment or confinement.
Earnings run up. Nothing more.
Interesting patent lowering trigs.....but does it lead to a significant reduction in cvd?
BB, your a single voice, I've supported the EPADI movement for quite awhile, written my congressman, and written Amarim IR. Just becaus I don't foam at the mouth and howl at the moon doesn't mean I'm not active...
Well amarin people working on formularies must not be doing a bang up job if everyone's coverage is dropping a tier...and lord knows the company needs those scripts to weather the storm...
Mgmt not knowing about tier coverage dropping to tier 4 in 2017 would really worry me. Mine is aetna and I was notified 3 weeks ago...
Drrc....when we continually get $6 pt, based on so called multi billion revenue sales opportunity...something doesn't add up and the market knows this...
Vu, I saw cafe pharma conversation the other day and decided to ignore it. In my experience it's been mostly a board for unhappy reps to vent about their company or competition.
LDL-c reduction...so does the FDA consider reduction in that lipid marker to a decrease in CVE? We know they don't feel that way about trigs!
JL, still long this stock, just don't post anymore but the idea that Amarin tried to sneak in expanded labeling is just a farce. Here are the excerpts out of the adcom briefing doc:
FDA Briefing Document
Endocrinologic and Metabolic Drugs Advisory Committee Meeting
October 16, 2013
The applicant now seeks the following indication:
? Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
8. BENEFIT/RISK EVALUATION IN CONTEXT OF CURRENT SCIENTIFIC KNOWLEDGE
The indication sought for VASCEPA as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent is based on the lipid changes observed in the ANCHOR trial. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes. The experience with statin therapy, where effects on the lipid profile (primarily LDL-C) consistently later translated into proven cardiovascular risk reduction, seems to provide a supportive example. However, as demonstrated in large trials of patients with congestive heart failure or end-stage renal disease on dialysis, even lowering LDL-C with statins does not always appear to decrease cardiovascular risk. More relevant to the current proposed indication, other non-LDL-C lipid surrogates (e.g., TG) have not uniformly conformed to the paradigm that improving lipid values reduces the risk of cardiovascular events, especially among contemporary patients treated with statins. Therefore, in considering the benefits of AMR101 treatment and the implications of granting approval for co-administration with statins, EMDAC members should consider the clinical significance of the observed lipid changes in ANCHOR in the context of the available scientific knowledge, such as clinical trials and meta-analyses that have evaluated the cardiovascular benefit observed with omega-3 FA consumption as well as recent large cardiovascular outcome trials that have failed to demonstrate a reduction in residual cardiovascular risk with non-statin lipid-altering treatment, despite improving parameters such as HDL-C and/or TG, in patients optimally treated with statin therapy.
Sent from my iPad
It's a sales strategy and is quite valid....gives the rep a great reason to continue calling on the practitioner..."hey doc, i got more/new information for you", and it gives the rep the opportunity to refresh the docs memory....when ya only got one product to sell, you gotta come up with more ways to get in the door!
Well said Z! I'm amazed at some of the opinions that this cc was negative. I see growth, I see court wins, I see a legal team that has paved a path for management to work with the FDA to a favorable conclusion. I see caution as a positive. Let's not give the FDA anything to reverse the courts decision. If dilution is coming due to slower ramp up, then so be it, better dilute and survive and grow than go bust. When reduce it is a win, dilution will be a distant memory (say stock buy backs). I also like the latest comments by Suntrust...maybe no dilution at all...if deals are done!
Earnings estimate based on management guidance, not analyst projections...thereby creating a more realistic outlook, and eliminating guesswork of 1A impact....imho.
Given the high thresholds of overwhelming efficacy and safety typically required to be achieved prior to an independent DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, management continues to believe that it is most likely that the REDUCE-IT study will run to its completion.
I second that!
Is English that difficult in that it takes 60 days to agree on truthful but not misleading statements? Didn't the court already lay out the framework?
Good luck getting an answer from him on that one mr main. I asked the same two years ago and all I got was more mgmt sux rhetoric.
Yes, got it today for the first time...$9 co pay card is pretty sweet deal and my knees have never felt better!
Agree with your point of view however if there's one thing to be learned about the stock market...it acts irrationally. But on the logical side it would appear the street won't be duped again by the fda... And only significant scripts will move pps at this point outside of partner/buyout.
Yeah now all ya gotta do is pony up $60k to extend your miserable life for 3 months with medication....
FDA off the hook now, should not appeal as they can come out smelling like a rose. If R-IT ends up less than satisfactorily, they can blame the courts, and if R-IT is a success, they can always maintain they were just looking out for the publics benefit.