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.
Just more of the same - why are not the 800 reps educating pharmcists!! I give up - yup take your otc fish oil .... I'M selling out tired of wasting time on this company ....
"Patient needs refills on brovana, vascepa, and ipratropium bromide. insurance will not cover certain meds but substitutions can be made: duoneb for brovana, pharmacy recommended fish oil to replace vascepa. last visit 9/30. last cpe 9/16."
RFF is your RX for Trigs >500 or REDUCE-IT?
If the latter then can the state be sued for promoting patent infringement ?
I see the advantage of EPA is its an anti inflammatory that does not reduce the immune system
Yes that is the billion dollar question - if it worked on corona great - but then will it work in other respiratory viral illnesses ( ie the common cold ?) multibillion market !! very long shot but at this point we will grab any handhold given us - I think it probably wont work if it was amazing Bhatt would be totally quiet then hit the press with an explosive finding that would go totally viral ... we can dream
The modus operandi of insurance companies is to unnecessarily complicate the system for anyone trying to extra resources be it patient needing testing / meds or physician trying to get paid - the more you obfuscate ..the more cash you keep
NO one has questioned some have ignored ( mainly the large mail order ones)
yes Vascepa does not move the numbers well at all - as a matter of fact before REDUCE IT I was indicating that I had concerns that it really did not move trigs well at all and lovaza worked better and yes vascepa barely touched ldl. I like many others was upset at FDA for asking for outcomes study instead of just focusing on markers - yet in the end we have to thank them - we are all realizing that makers are only that - pcsk9's reduce LDL tremendously - yet provide minimal benefit for CAD reduction - as we obtain more understanding it is becoming apparent that inflammatory reaction may be playing a larger role than what we expected - EPA reduces inflammation as do statins - the difficult process is docs are number focused - what is the ldl etc we need to get them to understand that a medication may not effect a number yet still provide benefit - because we are not looking at the correct number if there is even one that can be measured -
Jfmcrr // HK
SO you believe that Vascepa reduces CAD risk ...but only if used with a statin ? THat if used alone it would provide no benefit ? Interesting so you believe that there is a synergistic component and that it must be combined with a statin to have any benefit whatsoever ... that it can only work on residual risk but not initial risk ....
according to Cochrane
"Differences in risk between people treated with and without PCSK9 inhibitors suggest the absolute treatment benefit will likely be modest (e.g. less than 1% change in risk)."
SO I can give them a pcsk9 for $12 k per year or vascepa
NO one is advocating getting rid of statins - but in statin intolerant patients vascepa it is a wise choice
HK I place this on every script - substitution of generic EPA for REDUCE-IT indications will be considered patent infringement
Then in notes to pharmacist ....
Filling this script with a generic substitute is a violation of patent law and may be prosecuted for financial restitution
North ...certainly a great choice for people who are statin intolerant - insurance wont pay for that indication --- not included in REDUCE IT study since statins are the mainstay of treatment could not deny people that med (with a statin intolerant group they could have )
With a study showing it to be as good as statin - you would eclipse the multibilion statin market instead of just having one little piece of the pie
GAry this was one of the major flaws of the REDUCE IT study that I have repetitively cited - It would have been so easy to include statin intolerant patients - would have blown open the whole statin market
COVID - I do hope COVID data will be + however, my guess, from a gestalt of years of practice says no. What often happens in these situations is the basic science will suggest potential , however, the complexity of biological systems and inability to control the myriad of factors results in failure - Through 35 years I have watched all the breakthroughs for cancer fall flat on their face - so my guess is no influence - hope I am wrong ...
IN the meantime my next hope for cancer Car-T cells - tons of research going on - need a biotech fund that invests in just this
OK Sleven I think I see what you are saying ...
If HIKMA files an ANDA for trigs >500 then the court will have to decide if that ANDA will infringe on REDUCE IT prescribing -
if that is the case then perhaps I see why AMRN is delaying.
It will give them a chance to compile data revealing that Rx's are being filled currently for REDUCE IT indications - present that to the court and it would be hard for them to refute the evidence ...
this link still works for me
https://www.lexology.com/library/detail.aspx?g=d9c61069-f0d6-4128-acec-260b9f27595e
I am not a lawyer but to me this suggests that unless HIKMA is filing an ANDA for REDUCE IT indications there is no infringement ?
The statute explicitly defines the act of infringement as the filing of the ANDA. The infringement case is therefore limited to an analysis of whether what the generic drug maker is requesting authorization for in the ANDA would be an act of infringement if performed. Here, the request to make and sell a drug labeled with a permissible (noninfringing) use cannot reasonably be interpreted as an act of infringement (induced or otherwise) with respect to a patent on an unapproved use, as the ANDA does not induce anyone to perform the unapproved acts required to infringe. That a generic maker may someday induce someone to infringe can only be determined when that act occurs, and § 271(e)(2) was not designed to cover such future acts. [Emphasis added]
FFS I dont know if you saw my post of analyst predictions - there was a dramatic surge in OCtober - my question was - has anyone researched doing an EMA on analyst predictions and how that fares as a predictor of stock price ?
Then the billion dollar question becomes - will it work on the common cold ...can you imagine the market !!!!
Translation - If AMRN is willing to give them additional time my guess is they are working cooperatively on something - other wise why give them more time to build a stronger case - doesn't make sense?
Another interesting thought about Vascepa - we now have meds that are potent reducers of inflammation ( steroids and all the rheumatological drugs ) however, they all also suppress the immune system - a major problem
Does Vascepa suppress inflammation without suppressing the immune system ? Wow that would be amazing and might serve as a portal into further research regarding reducing inflation without suppression of the immune system ...
Examining the articles being presented at NLA gives us insight into AMRN's direction . AS we all surmised many years ago Vascepas reduction in CAD may be linked more to reduction of inflammation than trigs etc . Statins prob work as result of the same mechanism and LDL may not be what we think it is (more likely simply a marker- which is why PCSK9's did not fare nearly as well in reduction of CAD)
AMRN's short term goal is to combat DHA as evidenced in the below research their long term goal is going to be this focus on reduction in inflammatory processes and how that may effect certain disease states. THe difficulty here is that severe inflammation is currently being addressed by many of the rheumatolgical drugs - and what disease states will it work best in ? The goal of reducing inflammation in viral illness is certainly interesting - will it reduce the symptoms of the common cold ? huge market ... easy study - market will stay even with covid vaccine ..... very interesting very huge market !!
“EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial” – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST
“First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial” – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA – December 12, 4:30-5:15 pm CST
Other Amarin-supported REDUCE-IT abstracts to be presented include:
“REDUCE-IT USA: Results from the 3146 Patients Randomized in the United States” – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD
Other Amarin-supported abstracts providing mechanism of action insights include*:
“Eicosapentaenoic Acid Maintains Normal Membrane Cholesterol Distribution under Hyperglycemic Conditions unlike a Mixed Omega-3 Fatty Acid Supplement”
“Variability in Content of Omega-3 Fatty Acids and other Fatty Acids in Multiple Lots of a Widely Used Fish Oil Dietary Supplement”
“Eicosapentaenoic Acid Improves Endothelial Nitric Oxide Bioavailability and Changes Fatty Acid Content in a Manner Distinct from Docosahexaenoic Acid”
“Eicosapentaenoic Acid Reduces Expression of Pulmonary Endothelial Angiotensin Converting Enzyme (ACE) Linked to Inflammation”
“Eicosapentaenoic Acid Reverses Endothelial Dysfunction following Exposure to the Cytokine IL-6 in Contrast to Docosahexaenoic and Arachidonic Acids”
I suspect a lot of those patients are also on statins and statins and fibrates should not be used together - one case of rhabdomyolysis and he will be sued big time ... someone may wish to bring him up to speed
Average Analyst rating $10.05 - strong buy
What I find interesting here and maybe some of the chart guys can tune in - note the very significant escalation in analyst price prediction starting in October of 2020 - has anyone looked at analyst ratings via a 30 or 90 day EMA and if so what is the predictive value ?
I find this favorable - my goal was to double my money in 3-4 years ...in at $4.xx out at $10.xx will certainly do that -
https://www.nasdaq.com/market-activity/stocks/amrn/analyst-research#:~:text=Based%20on%20analysts%20offering%2012,a%20low%20estimate%20of%20%244.
Define "pure"
Define "fish oil" how much is DHA?
...and the response should be --- the result will be complete stagnation of innovation in health care killing millions as a result of cures that go undiscovered as corporations flee from biotech and move into electronics and other fields where patents and research are duly recognized
Hilarious - I do that for free for 8000 active patients - I guess I have spoiled them for so many years - they expect same day appointments same day call backs - many have my personal cell etc all for free
The best way to sum up the issue of infringement is that famous quote by Justice Potter Stewart explaining "hard-core" pornography, or what is obscene, by saying, "I shall not today attempt further to define the kinds of material I understand to be embraced... but I know it when I see it ..."
We know infringement when we see it .....
Nice work PD ! Question on page one you state :
_________________________________________
Both EPA and AA are pro inflammatory.
________________________________________
Yet in the diagram you have EPA labelled as being anti inflammatory ?
I once had a company go private they allowed me to be part of the company as a non voting share holder - I made out extremely well
Nice article Post #
308495
of 311266
The company is not without value - it will slowly build over time .
1.) Science is strong
2.) They have EU and Canadian markets.
3.) CHina and the rest of the world may contribute some to the market.
4.) The US market may still allow sales via several pathways.
a.) Successful prosecution of infringement
b.) Inability of generics to produce supply
c.) Other uses - Covid - (strongly doubt extinguished by vaccine)
NASH maybe but market not that big
FOr these reasons - stepping back and knowing that if you can double your money in anywhere from 2-5 years you will beat almost all professional investors - I think this is a play - invested at $4 hoping for $8 in 2 - 5 years. For those of you who got in higher you can either load up now on the discount or take your losses
AMRN should provide that legal counsel free for patients and physicians ....
Most pharmacists like most Docs have no idea whats going on with patents etc., they are just trying to get through their day - most are paid by the hour they garnish no personal benefit from substituting one drug for another - if you are filling an rx every 50 seconds you simply cant take the time to research this especially for a drug that compromises probably 0.01% of your daily activity - I think the issue is the pharmacy corporations management - somewhere higher up is where that decision is being made to substitute that med and thats where AMRN should be focusing
Ask your doc for the $9 coupon or go to the website and see if you can get it there - also if they are rejecting the script or asking for prior auth the company can give him or her a nice 8 page letter that he can send them to digest
SOunds like we should mount a write in Campaign to CC about Nissen and how he is letting a personal vendetta cloud his scientific judgement and this is now spilling over into effecting patients health care
Bhatt TOTALLY and I mean TOTALLY destroyed Nissen - he did it politely - but if were Nissen I would be doing something to retain my standing as a competent and HONEST practitioner right now he just looks like a ......
How much are they being paid by astra zeneca ??
and then they will say that the corn oil caused CAD and it needs to be done with motor oil as the placebo ... and on and on
Yes and then whatever they use for the placebo next time will be challenged ad nauseum .... truly embarrassing .... from what i recall didnt FDA sign off on the REDUCE IT study IF so then they cant complain about the use of mineral oil
OK Good news
AMRN finally gave us an 8 page letter to use for Prior Auths
just used it this AM and the response from Insurance company that was battling us was -
Patient does not need prior auth...dont ask me how it changed from we need one to we dont need one as that goes on all day long and we dont have time to review every patients formulary coverage plan
heres what actually happens - if you can pile more papers on them than what they pile on you they give in
I remember once I ordered total IgE levels for a patient and insurance company rejected it I printed out studies and sent about 200 pages to then why I felt that test was warranted they approved the test
WHich is why all reps need to tell docs when they write the RX to indicate
"For REDUCE-IT Criteria"
Still have to wonder why hes playing options for $1
Yes this certainly does reflect malignant obfuscation for ulterior motives --- Its hard to believe that anyone would be so petty