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EXAS went up about 4 dollars a share after their last offering. All about demand simply stated.. we shall see i'm buying
what's going on AH? a raise or hit piece?
FFS, EXAS is an interesting comparison. I have been long the stock since late 09'. They got ambushed by an odd USPSTF draft guidance that left them off the A list for CRC screening. It has been as high as 30+pps. Market cap now around 1.3B with an increased ramp do to revised USPSTF inclusion, HEDIS rating and mandatory insurance coverage within the next 12-18 mo's it could see mid 40's by 2018
i'm off label healthnet in AZ ... 40 bucks 4g
my mother in law was recently hospitalized with pulmonary edema probably misspelled .. anyway fluid builds up around her heart/lungs ... she asked her cardiologist about vascepa .. she has stints, bad lipid panel, bad diet,overweight etc. .. regarding vascepa he said it won't hurt you or help you... i agree with JL this is about reduce it and doctor education
USPSTF draft guidance out for statins- in summary take them early and often :)40-75 with a 10 year risk of cve of 10% or greater and you smoke or have diabetes, hypertension or dyslipidemia ... there is more guidance if your risk is your risk is less than 10% and of course the dose is lower but it appears any smoker, any person obese or any person with diabetes would benefit on some level... come on reduce it !
i have read from a few posters that the reps are NOT promoting Jelis and Anchor to the docs... listen to JT around the 30 minute mark on this a.m. presentation... they indeed are presenting this NEW information to the docs and it takes 5 to 7 x's for the doc to change his prescribing behavior. JT thinks the stock is undervalued at today's prices.... very very unusual to hear a CEO stick his neck out like this... i'm encouraged to say the least.... i'm long and on........ the 'on' means 4 grams a day for 18 months now :)
zum, i read this as well this a.m.
Our data also suggest that we need to address 'residual inflammatory risk' as being separate and distinct from 'residual cholesterol risk' and use these ideas as we move forward with precision medicine," Ridker said
zip, I would be surprised if there are side effects.. you were just saying as a possibility, I understand... I know in my circle those taking Vascepa 4 g daily have had zero side effects ...anecdotal but real life experiences
zip I agree on that point as well to avoid or deflect further scrutiny over that adcom debacle amrn is in a good negotiating place contingent upon of course the drug to be modestly effective or more
Zip that seems reasonable to me cya and then take credit for being prudent
My cardiologist/friend has me, my wife, himself, his wife and adult children on Vasecpa 4 g per day off label.. costs me 40 bucks through healthnet in az... anecdotally since i started i have not had to urinate as frequently in the middle of the night? no idea if it is related but my liquid consumption has not changed; did it help this 54 years olds prostate?
Don't base the effectiveness of a drug on Kaiser's coverage decision or waiting on an outcome study. They have proven to be quite myopic in other area's ignoring evidence and science to save a buck in the short term. I have an example in colon cancer screening that takes us back to the dark ages that they engineered the outcome... scary stuff
one would think we would have a modest run up into cherry results?
Shouldn't we know Cherry Study results about that time too?
Dew, I agree less than a ringing endorsement... obviously there is some confusion on the results of deep c and longer term perspective.. if you had to choose between CG and FIT nobody chooses FIT. Kaiser does a great job with FIT compliance but nobody else does that's a problem as most untreatable CRC is diagnosed in the ER
according to greenday bio tweet ... amrn is filing a motion to dismiss the Watson intervention by eod Monday 9-14
Zum probably already posted this but it's worth seeing again for those who may have missed
The team established that an enzyme called LPCAT3 (Lysophosphatidylcholine acyltransferase 3) is involved in the biosynthesis of phosphatidylcholine (PC), a type of compound lipid that is a major component of cell membranes. Dr. Jiang found that LPCAT3 deficiency significantly reduces polyunsaturated PC levels in the plasma membrane of the cells that line the intestines, which in turn reduces lipid absorption and decreases levels of lipids (cholesterol, triglyceride, and phospholipid) in circulation.
“Hyperlipidemia, or high levels of lipids, is a common disease and contributes significantly to cardiac related morbidity and mortality,” explains Dr. Jiang. “Statin drug trials have provided the major evidence for the benefits of a therapy that lowers low density lipoprotein (LDL), the so called ‘bad cholesterol,’ and statin therapy is now the mainstay of clinical management of cardiovascular disease. However, there are many instances in which patients do not respond to or cannot tolerate statins.”
Because of this, there is an urgent need for additional approaches to lower plasma lipid, preferably acting synergistically with statins.
Tort, If I'm a commissioned sales rep yes part of my pitch is
There is little doubt that Reps will very soon (if they're not already) be starting to share JELIS & ANCHOR data.
I wonder out loud if the reps could include in their pitch the Pleiotropic effects
for instance improves endothelial function, the anti inflammatory effects, anti oxidant effects and the inhibition of cholesterol crystalline domains?
And yes, JT was cautious about chronic condition prescribers not changing their behavior overnight.
Kiwi, that's the issue...meta-analysis is not enough unless of course you are sick :(
cmm, well stated ... I also believe there is an adverse publicity risk for the FDA by waiting for reduce it results IF Vascepa is later shown to be effective in lowering CVE given it's safety profile. There is enough anecdotal evidence to surmise reduce it will prove Vascepa beneficial in reducing CVE. The safety profile would make me a bit nervous if I was an FDA official. I would dread being asked 'why with all that gets approved with potentially serious side effects do we not give Vascepa the benefit of the doubt if nothing else based on Anchor and other anecdotal analysis i.e. Jelis?'
JL I concur .... the biggest challenge will be in doc/patient education. Could this be circumvented eventually direct to the consumer? absolutely! my mother in law with a rotten lipid panel, 3 stents, 1 m.i. and many hospitalizations related to CVD couldn't get her cardiologist to prescribe vascepa adjunctive with her statin.. finally her PCP relented. last night at dinner she told me her blood work is much better .. her b/p is normal. she still calls vascepa a vitamin but I just smile :)
not horrible .... he just doesn't understand what NCE stand for...
But what if the trial succeeds? Amarin will then have conducted a definitive and expensive study to win a landmark claim that its product improved CV outcomes. And the company will also have established the legal principle that anyone else selling fish oil can make a similar claim without paying for the trial.
I believe at that point it would make sense because it is so beneficial on several different levels.... a prescribed vitamin on steroids... my PCP was handing out samples of Vascepa in his office today :) I have my own script but grabbed a box anyhow
Endothelial cells and MVD and Afib
http://www.ncbi.nlm.nih.gov/pubmed/25115553
I also recall them bringing up bleeding times and the inert ness of the placebo? I have never witnessed anything like this with vascepa's safety profile.... absolutely avoidable by the FDA
If all of us were willing to post chas's commentary via our FB accounts detailing Vascepa's journey one never knows who or how the truth will be revealed. FDA, BP and Wall Street are corrupted by ignorance, apathy and greed. I wouldn't count on any form of the government to remedy this wrong.
i added today
1949 .... a day that will live in infamy as far as my portfolio is concerned :) a cardio surgeon turned me on to amrn back in 09 or early 10 ... i've been chasing the sweet NCE ever since... i take it off label as do many of my family and friends including the heart surgeon and his family.... we were a head of our times and the fda or some persons in the fda got bad info or cut a back room deal
yes lots better than Colo or fit but I agree it could get better
Dew what did you think of the total of 80k tests ordered but for errors and lack of coverage obviously didn't all get completed?
Health net 40 bucks
SOP 5-7 days prior to surgery
Zum, i would love to read about your eye witness testimony from that hearing!
i found this thanks to BB from earlier post
ORDER granting in part and denying in part [21] Letter Motion for Extension of Time to File Response/Reply re: [5] MOTION for Preliminary Injunction. Oral argument, currently scheduled for July 7, 2015, at 9 a.m., shall proceed as scheduled. See Dkt. 14. However, to give the Government time to thoughtfully address in its brief certain regulatory guidance which it states will be issued on June 5, 2015, the Court will modify the briefing schedule as follows: The Government's opposition to plaintiffs' motion for a preliminary injunction is now due June 18, 2015. Plaintiffs' reply is now due June 25, 2015. The Court further directs the Government to file on ECF the FDA's regulatory letter by June 8, 2015. The Clerk is directed to terminate the motion pending at Dkt. 21. (Responses due by 6/18/2015; Replies due by 6/25/2015.) (Signed by Judge Paul A. Engelmayer on 6/2/2015) (kl) Less
Can someone post a timeline on the court stuff through July 31st please? i realize this is a moving target dependent on responses, etc. tia
Dew when do we see the short squeeze?
i want the ceo to communicate in a manner where an investor who has listened to several presentations can discern the future without having it spelled out... i don't need smoke up my hiney... if a ceo has been cautious in the past and now exudes confidence and he is a man of integrity for me that tells me what i need to know to stay long
Zum, this may be the anecdotal evidence regarding epa and kidney fu.
so i found this today regarding kidney function .. any anecdotal evidence with EPA here?
They found that both GFR levels and albuminuria independently improved prediction of cardiovascular disease in general, particularly heart failure and death from heart attack and stroke, but albuminuria was the stronger predictor.