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HK we need you to write JAMA and point out this purposeful misdirection by NIssen !
Exactly - he knows this but he also knows he can obfuscate these facts and most docs wont pick up on it
Exactly DHA and EPA are DIFFERENT molecule and to imply that they would have the exact same effect is at best unscientific but more likely reflective of malignant obfuscation for ulterior motives
Unfortunately most docs have no understanding of DHA and EPA - as a result if you can have a thought leader say look fish oil or Omega 3-s dont help they believe they will pull vascepa down with this - this is why AMRN must use all resources ( ie all those reps) to constantly hit on the point that VAscepa is not DHA and there is a HUGE difference
Agree - you cant make any statement about vascepa when you are using a product that contains DHA - this is ridiculous - its like a patient taking a statin with arsenic - and then when they pass on saying see statins are bad ..... this is ludicrous -
I can only hope that MD's understand the difference between DHA and EPA and that AMRNs marketing department attacks this point aggressively as should BHatt
Here is Nissen's explanation of DHA
________________________________________________________________________
The omega-3 fatty acid formulations differed in terms of their composition. While cardiovascular benefit has been reported with administration of purified formulations of EPA, omega-3 CA is a combination of EPA and DHA, with the potential to achieve similar tissue EPA concentrations. Theoretically, the lack of cardiovascular benefit with omega-3 CA could reflect adverse effects from coadministration of DHA. Although preclinical studies have reported potentially differential biological effects of EPA and DHA in studies of endothelial cells and vascular reactivity,29-31 DHA has not demonstrated an adverse effect on atherosclerosis32,33 and DHA levels have been reported to associate with cardiovascular protection.34 Furthermore, while the increases in plasma and red blood cell concentrations of EPA were substantial, the percentage increases in DHA concentrations were modest (Table 2) and did not correlate with event rates (Table 3). Accordingly, it seems unlikely that the DHA component of the omega-3 CA formulation caused harm.
_______________________________________________________________________
Was he bypassed to BHATT to do the REDUCE IT study - looks like he has a personal vendetta
HAve not read study but slide says
___________________________________________________________________________
To evaluate the effects of a carboxylic acid
formulation of EPA and DHA (omega-3 CA) on clinical
outcomes in patients at high cardiovascular risk.
___________________________________________________________________________
WEll of course if you have DHA that is going to raise LDL and therfore atherogenic potential so no wonders there was no benefit
It is perfectly legal as long as he reports it to the SEC - that's why there are insider traders sites - so you can ff what the company execs are doing ....
Another PA - note what I have highlighted - coverage is NOT included for non FDA approved conditions - DM2 being one of them - hilarious
Traditional Prior Auth
Please provide all information requested. Failure to complete this form in its entirety may result in delayed processing or the PA request will be closed for lack of information
Does the patient have a diagnosis of hypertriglyceridemia? Note: Coverage is not approved for use in non-FDA approved conditions, including the following: Attention Deficit Hyperactivity Disorder, Alzheimer's disease, bipolar disease, Crohn's disease, cystic fibrosis, dementia, depression, inflammatory bowel disease, intermittent claudication, metabolic syndrome, osteoporosis, post-traumatic stress disorder, renal disease (immunoglobulin A nephropathy), rheumatoid arthritis, schizophrenia, Type 2 diabetesmellitus, and ulcerative colitis.
No
Not an expert on this but here is my understanding .
A company's directors, employees, and management can purchase or sell the company's stock with special knowledge as long as they disclose those transactions to the Securities and Exchange Commission (SEC); those trades are then disclosed to the public
Amazing !
Theros purchases / sales :
My question is - why didnt he wait until today to sell after presentation - he had to know it would bump the stock ? This makes no sense to me - thoughts ?
Ordinary Shares(1)(2) 11/09/2020 M 134,739 A $3.4 2,691,144 D
Ordinary Shares(1)(2) 11/10/2020 M 615,261 A $3.4 3,306,405 D
Ordinary Shares(1)(2) 11/10/2020 S 153,840 D $4.134(3) 3,152,565 D
Ordinary Shares(1)(2) 11/11/2020 S 413,565 D $4.0651(4) 2,739,000(5) D
Yea dont ya love it - every other profession can be educated by suppliers - my friend is an architect MARVIN flies him out for a week "vacation " education every couple of years and thats OK . Politicians can get millions of dollars of donations but God forbid you give a doctor a free pen ... because they will all just go crazy writing Rx's if they get a free pen
I agree - great science - great results - horrible business execution -
I am hoping that the reps start to educate some of the cardiologists - or AMRN can hire me ....
1.) Its not for the pharmacist - its for future evidence for infringement cases
2.) Most pharmacists will then familiarize themselves with REDUCE - IT
I am writing mine :
Vascepa 1 gram Sig: 2 tab bid for REDUCE IT criteria - Substitution of a generic will be considered patent infringement
This automatically puts the pharmacist, insurer, pharmacy chain etc on notice - if they substitute they are infringing - they cant plead that they were unaware
ASk your doctor to write the RX Vascepa 1 gram Sig: 1 tab bid to fulfill REDUCE -IT criteria
If docs put the word 'REDUCE IT criteria' and they substitute - then that is clearly infringement
No one questions the science - buying on the science only makes sense if the business is as capable ..... and that's what everyone is now questioning
Having bought in the $4.xx range I cant fault you as I do think we will double in several years and that still is a very good investment. Unfortunately many here bought much higher and so their point of view is going to be much different ....
Jan.Heek@amarincorp.com not deliverable
WOw !!! Fantastic job !!!
Piper Sandler analyst dropped us from $21 to $19 - rofl - would take the $19 no questions asked ....lol
My thinking is you have 800 reps that are not seeing docs right now - why not put them to work educating insurance companies ?
here is another hes talking about vascepa
__________________________________________________________________________
pt called bc aetna told him 2 of his meds will cost over $400. he doesnt know which ones and he wants you to forget about them.
___________________________________________________________________________
this goes on all day with vascepa -
OK here is my latest RX please note the response for prior Auth - they still think its only use is for Trigs > 500
800 reps sitting around doing what ???? THis is ridiculous
my RX :
Vascepa 1 GM Oral Capsule Verified WRITTEN DATE
11/12/2020
Medication
QUANTITY
360 Capsules 1
DAYS SUPPLY
-
NUMBER OF REFILLS
3
SUBSTITUTIONS
Not Allowed
SIG
Take 2 capsules BID patient meets REDUCE IT criteria - no substitution is allowed for this criteria and is patent infringement
Prior Auth response :
Vascepa (Icosapent Ethyl) 1 GM Oral Capsule
Questions
Does the patient have a diagnosis of hypertriglyceridemia? Note: Coverage is not approved for use in non-FDA approved conditions, including the following: Attention Deficit Hyperactivity Disorder, Alzheimer's disease, bipolar disease, Crohn's disease, cystic fibrosis, dementia, depression, inflammatory bowel disease, intermittent claudication, metabolic syndrome, osteoporosis, post-traumatic stress disorder, renal disease (immunoglobulin A nephropathy), rheumatoid arthritis, schizophrenia, Type 2 diabetesmellitus, and ulcerative colitis.
No
Supporting document (optional)
Attach document
Additional comments (optional)
Patient meets REDUCE IT Criteria I cant actually believe that this question is not being asked you are three years behind ....
If the judges staff did it that allows her to "save face"- admit her staff made a mistake and correct the issue - if HIKMA did it intentionally its an attempt to mislead the judge I would expect any judge to be upset over that - those are my wishes - what is the reality of all this - it will be seen as irrelevant and swept under the rug
I find that to be be even more egregious - if they had the complete table why didn't they show that to the judge ? Why did they go through the EXTRA effort of cropping the table ? - that action in my naive legal expertise clearly shows intent to defraud
That is correct Joe BIden age 77 appointed a doctor who believes people cant be functional after age 75 - its only going to get more hilarious over time
NOte that the listing in only for high triglycerides and this is how they are going to do it - this is why getting the MD to write FOR REDUCE IT INDICATIONS on the RX will allow prosecution of infringement cases
I will tell you the problem with lack of MD pickup
There is a prejudice that if its not complex synthesis that it cant be useful - I am not saying that Vascepa is not complex - I am saying that docs think its "fish oil" and if its fish oil it cant really be better than something that was produced through 1000's of hours of research in a lab - this is well summarized in my local cardiologist statement "its just fish oil" and why would anyone pay that much for fish oil - and that's why there is no traction with many MDs - it is these points of the end game that AMRN continues to miss - dealing with the daily mechanics of prescribing a med via doc pharmacist and insurer.
I think more importantly is to have prescribers write on the RX that it is for REDUCE IT indications ie.
Vascepa 1 gram Sig: Take two tabs bid for REDUCE-IT indication
Ok now if they substitute - thats infringement
This may be a path for AMRN - get the FDA /courts to agree that if the prescribers write 'for REDUCE IT indications' - the RX must be vascepa - that's doable by most docs
The issue facing AMRN as happened when VAscepa was released for trig > 500 is again - not prepping insurance companies . Here's what happens with most docs. YOu may have several choices in how you wish to treat the patient. If you reach for choice A and get your hand slapped by requiring a 6 page prior auth and then you reach for choice B and it goes through, you rapidly forget about choice A.
So a rep goes to a docs office and the Doc learns about Vascepa - they go to prescribe it and get the 6 page prior auth - most of them say forget this and never try the drug again. YOu have one shot and you have to make certain it works for the doc - otherwise they wipe it off their memory slate - this is why insurance prep is so vital
Exactly - this is where AMRN reps should be working - ironically I went through this exact process when VAscepa was first approved for Trigs > 500. I laid out how AMRN totally failed to prep insurance companies and now they have repeated this failure with the REDUCE IT indication - they did not learn from their first failure and i find this rather disconcerting
LOvaza - OMega-3 OTC and fibrates is what they suggest - unbelievably I have sent a letter to their medical director requesting a call
Excellent letter !!
response from Elizabeth
We last week reiterated our guidance that we expect approval in Europe in early 2021. We have no update to that guidance.
Warm regards,
Elisabeth
ie we can just fritter away time --- why ???? Clearly there must be some benefit to waiting .... but why - this either clearly is incompetence or there is a strategy that we do not see. I find it hard to believe that people at that level and this being their only purpose/ job / goal could possibly have missed this by negligence - there has to be another reason -
response from Elizabeth
We last week reiterated our guidance that we expect approval in Europe in early 2021. We have no update to that guidance.
Warm regards,
Elisabeth
ie we can just fritter away time --- why ???? Clearly there must be some benefit to waiting .... but why - this either clearly is incompetence or there is a strategy that we do not see. I find it hard to believe that people at that level and this being their only purpose/ job / goal could possibly have missed this by negligence - there has to be another reason -
response from Elizabeth
We last week reiterated our guidance that we expect approval in Europe in early 2021. We have no update to that guidance.
Warm regards,
Elisabeth
ie we can just fritter away time --- why ???? Clearly there must be some benefit to waiting .... but why - this either clearly is incompetence or there is a strategy that we do not see. I find it hard to believe that people at that level and this being their only purpose/ job / goal could possibly have missed this by negligence - there has to be another reason -
about 80% are being rejected - 3 rejected on friday
LAst Prior AUth I will ever do for Vascepa - Im done - this was denied
Is this an urgent request?
NO
Is the requested drug being used for an FDA-approved indication that is recognized as a covered benefit by Fidelis Care? [Note: DOCUMENTATION is required for approval. Please provide the diagnosis for the requested medication.]
YES
AS per REDUCE IT study the ONLY I repeat the only EPA approved med is VASCEPA to reduce the risk of CAD in diabetic with trigs >150 with two risk factors on maximum tolerated statin therapy THis patient meets this criteria and yet you continue to deny him and many others - this is WRONG!!
Does the patient's diagnosis require confirmation with documentation (such as hard copy lab values, genetic testing, diagnostic testing, or any other diagnostic confirmation)?
NO
Has the patient had an inadequate treatment response or intolerance to a majority (up to 3) of the preferred formulary medications for an appropriate treatment duration, based on onset of action or national practice guidelines? [Note: Please provide documentation of the medications used, dates of trials, and reason for failure.]
YES
There are no other meds that can be substitutes - you are encouraging patent infringement and this will result in a law suit - the only med approved vua the REDDUCE IT study is vascepa DO NOT try to substitute LOvaza or other omega 3's they have DHA which increases ldl b y 49% they have NO studies and are NOT FDA approved for the indication requested
Is the request for a combination product for which the separate ingredients are available on the formulary?
NO
Is the requested quantity within the plan's quantity limits?
YES
Interesting - you are correct - cash and short term investments were 648 million on 12/31/19 cash on hand was 100% or 648 million now cash and short term investments is 554 million and cash on hand is only 217 million. Can someone fill us in on what this short term investment of 300 million might involve ?
THis is what I have been saying all along - COVID vaccination makes Vascepa use in COVID irrelevant to a a large degree
Yes - I feel the same way at this point - the fact that 90% of my RX's are rejected and their seems to be NO EFFORT by the company at remedying this situation is to me rather amazing and unfortunate-
I always try to invest by what I see in my life - so when I was using Amazon a lot I bought it. What I see in my life with AMRN is not encouraging - I see a company that has good science but horrible management - the fact they never included statin intolerant patients in REDUCE IT study is a major flaw that would have opened up the market for direct competition with statins - this would have completely realigned physicians embracing the med. Currently I hardly get any Rx's approved - most my local cardiologists wont take it seriously etc - This all tells me this company has a problem - whats worse is I dont see nor have I seen any steps to solve these problem. Most pharmaceutical firms that are getting resistance from Insurance companies set up a hot line to aid practitioners in getting prior auths completed - AMRN is blissfully ignorant of these and many other strategies - many of which I posted about up to five years ago -