Swalchie , I believe I wrote that if AMRN dropped below $1.20 I would immediately sell half . I would have obviously timed it wrong and my basic capital preservation rules would require me to limit my loss's.
In the mean time ...I'll continue to accumulate AMRN at various times when it trades between $1.40 and $1.60 as long as scripts show a steady increase ( on a 4 wk rolling average ) .
And I reserve the right to change my mind ..;)
Thx for the updates Key
Trend supports Jefferies Co view of a " steeper upward trajectory in TRx in 2016 "
If AMRN is able to maintain a roughly 5% weekly increase ,then scripts total will double in 14-15 wks.
( rule of 72 )
Babybull I've read the filings
" Twice -daily dosing with Rhopressa had a greater IOP- lowering effect but also had a higher rate of discontinuation due to adverse events "
" Specifically , Rocket 2 found the overall rates of adverse events -mostly mild to moderate hyperemia - were around 65% in the once -daily Rhopressa and 78% in the twice -daily group "
I don't have a problem with Rho being approved. Just think patients will prefer an eye drop thats as effective without the Red Eye adverse event profile
JMO ...like I said . You can hedge your position by owning both
Century ...are U responding to me ? It helps if U identify who you are responding to .
Suggest you read the most recent CC and the Co's comments on the annual cost of Reduce -It .
babybull ...thanks for the large print . Due to my glaucoma it was hard to read the smaller script .
So if both work ( Rhopressa and Tradodenoson ) ....but Rho causes Red Eye but Trad doesn't ...which do you think I should use ?
You know you can always hedge your position by buying both , right. ?
I've traded in and out of AMRN since the Marine trial days of 2010 .
The last time I was long AMRN was starting Oct/Nov in 2014 ...selling out in early 2015.
I'm back in now because I believe they will make it ( with some dilution if necessary ) to an early 2018 read out . I believe that read out will show clinical benefit .....more then anything else we have seen to date as an add on the Statins.
There will always be the issue of " why not use Omegia Via EPA etc " which is a dietary supplement I have used...88% EPA ...about $66 a month. The answer is always Insurance coverage and co pays for Vascepa which you know is 96% EPA .
If R-IT reads out with anything close to 20% RRR , it will be a major game changer in the preventive treatment of CAD and strokes and MD's will want to prescribe Rx ( FDA approved ) drugs ...not " suggest " dietary supplements and insurance co's should be willing to cover with affordable co pays..
AMRN ( the stock ) looks pretty bombed out to me . Not many people post here any more . Swalchie's comments are always welcome as is anyone who can provide informed opposing views.
Bottom line ..I don't see more than a 20% downside from here ...and there are potential upsides like an Interim stop or faster script growth .
JMO ...good luck
Century From the recent CC
" Reduce it expenses to be between $30- $40 annually until study completion "
I expect the R-IT expenses to be closer to $40m this yr because of the Interim analysis and closer to $30m in 2017 since all they are doing is having patients do blood panels once every 3 mths .
As long as scripts continue to increase on a monthly rolling average basis , as we have seen so far in 2016 , then R-IT costs may be covered by revenue by mid /late 2017.
Hi Swalchie Well if Sun Trust's number are to believed , AMRN had a 4 wk rolling average increase in scripts of about 2.5% at the start of the year .
That has slowly increased to slightly over 4% weekly increase rolling average as of most recent data.
( 4 wk rolling average is to smooth out the trend )
Remember they can now more aggressively market Vascepa thanks to their 1st Amendment win /agreement with the FDA and the board has allocated a $10m spend for that effort.
Eire The cost of running Reduce It will decline significantly once the Interim analysis is complete .
Probably between $20- $30m for 2017 for R-IT alone.
They will not need to raise anywhere near close to $100m as long as scripts continue to increase as we have seen recently.
Realize that if they can increase scripts by 5% a week consistently, they will have doubled total script numbers in about 15 wks and might avoid a need fore funding beyond having Baker Bros take care of the debt due in Jan .
At consistent 2.5% weekly increase , total script numbers will double in about 30 wks .
Script growth is essential which is why Keystone's numbers are the thing to watch each wk
More on MD's and Veltassa .
My wife's rant ...she prescribes for dialysis and stage 4 CKD
."..filling out prior authorizations to justify to a PBM, with at most a random high school education, why the medication is medically indicated.
It no longer matters that a medical specialist, ie nephrologist, has prescribed the med.
What matters if the "moron at the other end of the phone" will fax her the prior auth and if it is the correct form and if she has the time to find the most recent weight, height, lab results, the meds tried and failed and when and for how long (and don't tell me that hey with Obamacare all medical records are computerized- yes with a terrible electronic records manager system, that was made for the bean counters to bill hours and evaluate efficiency- not designed by clinical providers with patient care in mind but that's another rant.
I digress ...Then the person with the hs education will suggest for example kayexalate or a low K diet- as if the the MD had not already factored these things into the equation.
And ultimately the PBM will seemingly deny or approve on a whim.
There U have it ...direct from some one that prescribes these meds. PBM ( Pharmacy Benefit Manager )
She finds it very time consuming and very frustrating .
PS Have you chk'd MYOK . A friend ( scientist / Stanford grad ) is very impressed with their CEO and program
Golong .. is response to your post .
1) Clinical inertia . Many MD's are reluctant to aggressively prescribe new drugs for the first yr they are out.
Many in Nephrology remember Omonty ...when thru all the trials , approved by the FDA and not until about the 20,000 th use did major adverse events take place.
2) The paper work and specialty pharma requirements of prescribing Veltassa is an issue for some
3) Re Statins ...actually pretty slow uptake in first year from what I remember . Everyone was concerned about liver damage . I'd been on a test run for Statins pre approval at UCSF and had to call in every 30 days , or they called me ..then blood test every 3 mths
Right now I expect we are in a holding pattern until we see what the FDA says about ZS-9
SS The diets for dialysis and stage 4 CKD patients sux....they are so restrictive .
Patients binge ..often on the wrong foods..often at family parties ..and end up in the ER with HK.
Prescribing them Veltassa enables these patients to lead more normal lives with less risk of ending up in the ER .
( dictated from my wife who treats HK patients )
Century It doesn't matter what AMRN wants . FDA rules. If R-It is not stopped for futility or at Interim then AMRN will continue R-IT to completion. They are completely prepared to do so and have repeatedly stated that is what they will do.
So relax . They continue to come up with ( and market ) evidence of benefit to help increase scripts numbers.
New studies from other sources continue to show the benefit of lowering high TG's or improving the EPA/AA ratio for those at CV event risk . A recent study out of Japan showed lower CV event rates for dialysis patients with high EPA/AA blood serum ratio vs those with the lowest EPA/AA serum ratio. ( Most dialysis patients die , unfortunately from MI's ( heart attacks , arrithmyia's ).
So if R-IT is not stopped at Interim ...it will run to final completion . That I think you can take to the bank.
Fins05 I believe detailed Interim results will only be released if the trial is stopped. Otherwise AMRN remains blinded except for a notification from the DMC ( data monitoring commission ) that the stopping boundary was not crossed and the trial should continue.
The Trial will then continue unless the DMC determines there is less then 3.5% efficacy ( RRR ) at that pt in time.
Then the trial will be stopped for futility.
Its always dangerous to make assumptions re Outcome Trials.
There is extensive research that supports the case for high serum levels of EPA being effective in reducing CV events . Much of it presented by poster Zumantu who unfortunately only posts on IHUB ...you might find his old posts on this board by a search
Hi Swalchie Two rules I follow . If any stock doubles from my purchase price , I immediately sell half.
If any stock drop by 20% from my purchase price I also sell half.
So whatever remains of my original position ( after either a 100% gain or a 20% loss ) I'll probably keep to 2018. If I'm lucky enough to have a 100% gain ...after selling half of that I'll often place a 20% stop loss on the remaining position . Did that with FCX recently where I was up 150% and with AMRN in early 2015.
On the downside ...If it drops below $1.20 then I've sold half of what I bt on Friday ..average around $1.52
I'll probably keep the remaining half just so I'll follow Cardiovascular research , clinical trials etc .
By the way ...todays Motley Fool article ...the author doesn't now much about PCSK9's.
I'm probably the only one to ever post on this board who is a candidate for PCSK9's .
My LDL cholesterol was as high as 312 before going on max dose Statins ( hetero FH ..inherited ).
Current view of my Cardiologist to to maintain max dose Crestor , max dose Vascepa , Med diet , lots of exercise , no smoking etc as with these meds and life style I can keep my LDL below 120.
PCSK'9's will really only be used by Hetero FH patients who can not tolerate Statin therapy .
There were 2 reports out today HC Wainwright and Sun Trust and unfortunately I don't think Yahoo lets you link them now . While I take these reports with a cup of salt , in Wainwrights Appendix there was a page on placebo rates , relative risk reduction , 967th events etc that I thought was interesting
As per an earlier post by frenzychess and Dr Ketchuns comments ...to the effect of "event rates track to our initial estimates "
What we apparently know is that the 967th event roughly occurred late March 2016. In which case with a roughly 5.2% placebo rate the RRR ( risk reduction ) is around 20% .
This is unlikely to be good enough to stop Reduce It at Interim ( Sept/Oct ) .
However if that RRR holds up to final R-IT read out in 2018, it will prove by far to be the best known FDA approved drug , to add to Statin therapy for most CAD patients .
AMRN is a high risk , speculative investment . Risk only what you can afford to lose.
Hi Swalchie .... I will accept I was early , wrong and probably be gone again ...if this drops below $1.20.
You raise valid pts . The question is ...are these known and factored in now ?
No one will be surprised if they need to raise funds to complete Reduce It .
Most will not be surprised if Reduce It is not stopped at Interim.
Both these issues have been acknowledged by the Co and discussed in a recent SA article.
One thing I am confident in is that if R-IT is not stopped at Interim , it will run to completion ( late 17 with data early 2018 ) ....ie It will not be stopped for futility. Then its a question of the degree of benefit of 4 gms of Vascepa for CAD ( coronary artery disease ) patients . Here I admit I have a bias as I'm a CAD patient and prescribed Vascepa with a Statin .....so yeah ... I want the drug to work : )
Back in late 2014 I made the case that AMRN would make it to Interim ( it was trading under a $1 and faced de listing from the Naz ). Well they will make it to Interim in actually better condition ( more cash on hand and steady script growth ) then I expected . The downside ( no stop and some dilution ) would not be a surprise .
Have you considered possible positive surprises ......like needing less funding then expected , scripts growing faster then expected etc .. By the way U are right . I never bet the farm on any one stock . AMRN will never be more then 10% of my portfolio.
I last bt AMRN in any size back in Oct / Nov 2014
If you search thru my posting history you will find a response to Raf date Nov2 2014 on the subject as well as a discussion of the pros and cons .
I sold that position in early 2015 after the Baker Bros became involved, and have been out of the stock since then. I was concerned the Co would burn thru their cash on hand.
On Friday I was buying again and may buy more next week.
At $1.51 on Friday this is basically a call option ( actual better than ) on good final results from AMRN's Reduce -It trial WITH the potential for an early stop at Interim analysis in Sept /Oct 2016.
Script growth is increasing . The evidence supporting EPA benefits ( thx to Zumantu ) continues to increase.
Baker Bros funded them in the past and a reasonable case can be made for their additional support when if / likely needed in late 2016 / early 2017.
I'm a CAD patient prescribed Crestor ( a statin ) and Vascepa
JMO ...akanz2 on Yahoo and Whalatane on IHUB.
Michael /Silver /Golong et al
Another Co you might look at is MYOK.
Those I know working in Sth SF Biotech scene are very impressed with the CEO and their program .
I have a position
Michael /Silver ...I'm not usually concerned about market manipulation but you have to wonder if some one / firm knowing the news to be released after the close ... pushed the price down early to load up at mid day.
I was watching the action in the morning , could find no reason to explain the sell off , figured the market was perhaps pricing in less then stellar data for TRV027...but then added to my position on my expectations for eventual approval of Oliceridine .