Actually I think mgt is probably more upbeat about fighting off AZN then about scripts
This fight has moved to conference level when the judge usually says put up or shut up .
Doubt if AZN can delay any longer based on " we aren't launching yet so no harm done "
Recent displays at the Metabolic conference indicate they are ready to launch if their attorneys give the green light......strictly second hand info ...was not at conference
Boundbrook. Well after another day like today , delisting may not be an issue .
If stock trades above $1 , process starts all over again ...ie must be below $1 for $30 days
Great vol towards the close , trading at 98c after hrs
Eiretekk. We know you would like to see RI shutdown but IMHO it's not going to happen .
The only real reason to invest in Amarin as far as I'm concerned is because of Reduce It.
I believe it will prove that 4gms of EPA ( Vascepa ) daily will reduce CV events in those most at risk ...ie prior MI , diabetics etc .....AND will likely be the only thing , for now , added to Statins that's further reduces risk
( we will know about Zetia mid month ...Improve It Trial. )
Well Johnny ...suggest you don't invest more then you can afford to loose
BioBill is reporting on Ihub that both parties are to submit a status report Nov 7th and tele conference ( I'm assuming with the Judge ) on the 13th .
The conference is usually to move things along . Judge ( in my brief experience ) tests both sides ...ie if your case or defense is not strong , dont waste my time ...
Attorneys will then report back to MGT ...give odds of winning or at least the time involved ( MGT will calculate cost roughly )
This is a must win for AMRN IMHO
I need to read up on it also .
IMHO , Amarins patents MUST hold .
I cant imagine AZN going ahead with the launch unless they are very confident they can beat Amarin in court ...the penalty's would be huge if Amarin prevailed.
In terms of dragging this out .. a tele conference is set in next wk or two correct . From my limited experience with those ..the courts attitude is often "put up or shut up " after which you either make a deal or prepare for court.
In fact ( again speaking from limited experience ) ..the tele conference can be like a mini trial with the Judge challenging both side ...AZN has delayed based on their statement that they weren't ready to launch the product so no harm done .
I think the Epanova displays at the recent conference clearly indicate their intention to launch ...at least thats what Amarin will be saying
As regards being behind AMRN . The AZN STRENGTH trial is a 6 yrs long trial . I'm not even sure they have started recruiting for it yet ...so they are really years behind AMRN's Reduce It.
Mark ...believe Epanova is in free fatty acid form and therefore maybe be different in that regard from either Lovaza or Vascepa .. I think the Epanova's composition of 15-25% DHA infringes on Amarins " composition to treat very high TG's " as it doesnt say 20-25% DHA .
Just my quick lay mans take
From their display at the recent Metabolic conference one would get the idea that they plan on launching Epanova at the start of 2015.
I still dont see how they get around Amarins patent on composition containing up to 20% DHA from either placebo or baseline.
What would you do in AZN's position ...run a new trial with composition of containing DHA greater then 20% from either placebo or baseline or try and stall Amarin as long as possible as Amarins cash reserves decline ( wait them out then negotiate a deal )
One can speculate all kinds all kinds of deals such as Amarin granting use of their patent for the very high TG market , in exchange for cash to complete Reduce It ???
Reduce it will read out years before AZN's STRENGTH trail
ESPR's drug ETC-1002 is NOT a PCSK9 drug ...in fact it will offer a low cost alternative to PCSK9's when its finally launched .
The question re current valuation , is more about whether or not the FDA will require an expensive , time consuming Outcome Trial be completed before approving , or just that the trial be substantially enrolled ...or approve solely on ETC-1002 's ability to lower LDL cholesterol .
Suggest you know what you own .
Hi Den and Boundbrook
Good to see you and others posting.
I'm all for opposing views ..just wish they could be presented without the personal insult BS stuff.
Frankly ..insults just undermine the argument ...whether pro or con AMRN
Wow ...for the past month I've been labelled as a soft basher ...now I'm a shill !!
For the record .
I have been in and out of AMRN since 2010.
I believe high blood levels of EPA reduces CV risk ...for those most at risk .
I have never been a great fan of Amarin management and had several exchanges with you back in 2012 over the CEO's sale of stock that year and the chances of a buyout .
I did not buy the buyout story and sold my position ( by chance ) right before they announced going it alone.
I subsequently bt back in prior to Adcom and the FDA rejection of the appeal and have lost $ on those positions.
I disagree with the FDA position . Vascepa should be approved for the Anchor indication solely on a risk benefit analysis ( no risk , probable benefit )
I believe anyone at risk should have easy and affordable access to Vascepa while we await the Reduce It trial data.
I am not suggesting anyone buy or sell AMRN. Its a high risk small biotech.
I currently have a long position
Do your own DD and decide for yourself.
I'm a little short on time so I may have to get back later
but in brief ... You say " you sound like an uneducated dolt "...well I came to the US under a grad student exchange program partly funded by the US Sate Dept ..so apparently the State Dept did not ( at least at the time ) share you views.
My biostat education is limited however to the one course I did online thru Johns Hopkins and what I've picked up from my wife who did clinical research at Yale
Are you attacking the JELIS trial or the benefits of EPA in reducing CV events ?
The benefits of high blood EPA levels are well documented going back as far as Dyerberg et al in 1975 , comparing the cardiac disease rates in the Inuit population vs the Danes .
I agree that the JELIS study has its limitations but my overall read of it is that its more likely then not that high dose of EPA will reduce CV events especially in those with a previous MI ... and especially if they are diabetic and have a low HDL and high TG levels despite Statin therapy.
Poster Jessie Livermore on IHUB probably writes the most aggressive defenses of JELIS
Anyway ...I welcome the exchange of views , particularly if they can be presented without the personal insults .
Made up the numbers ?
Read the research yourself
Google...... Circulation Journal 2009
" Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients with Coronary Artery Disease ....Secondary Prevention Analysis from Jelis "
This is a response to satisfied customer1 and info for others interested in these 2 trials .
These are just my opinions ..you are welcome to respectfully share yours .
IMHO Reduce It is NOT the Jelis trial redone in a US population .
The closest part of the Jelis trial to Reduce It , is the Secondary Prevention Analysis group
This analysis concludes with the following " EPA is effective for secondary prevention of CAD , especially in individuals with prior MI.....Satisfied customer ...THATS PRIOR MI
To even qualify for the RI trial you needed to have major CV risks , prior history of stenosis in your coronary arteries , stented , often diabetic as well , family history and so on
The secondary analysis of these patients in Jelis ( the closest to RI ) shows the following
Incidence of nonfatal coronary events ( non fatal MI , stenting , CABG etc ) ..21% lower in the EPA group
The 1,050 patients with prior MI ...The incidence of MCE in the EPA group was 15% , significantly lower then the control group 20% with a P value of .033...ie significant
The 537 patients with prior MI AND coronary intervention...the incidence of MCE in the EPA group was significantly lower (15% EPA/statin group vs 24.7% statin only ) P value = .008 Very significant
Note ...P values tell you how likely the results are to be reproducible if you run the same trial multiple times with new patients , same risk factors . .008 means very high likely hood to see same results
Now there are differences between this Jelis subgroup and Reduce it ...primarily level of LDL to start with and strength of the Statins used ....but thats another Topic Post
Just an FYI
The results of Improve It are more likely to effect ESPR more then AMRN
Trial is about first the reducing of CV risk with a drug other then Statins , ( we know Ezetimbe lowers LDL but does this method of lowering LDL ,lower event rates ) ...is there a benefit adding it to Statin therapy
Secondly about change in surrogate risk markers being an acceptable criteria for approving a drug.
There are a lot of questions around this whole trial especially its design. From what I've read, most benefit if any , will be seen in the hetero FH group.
Kaiser doesn't seem convinced .
I was prescribed Ezetimibe for the past 2 yrs ...recently they told me they were no longer renewing scripts ...wanted to wait for the Improve it data !
I have a position in ESPR but will wait for the reaction to the Improve It trial before deciding to add or not .
Appreciate your posts.
I dont mind if posters dont agree with me ...I want to consider all views respectfully presented.
Re financing .
Even if they feel they will be breakeven end of 1st Qt 2016 ...they wont want to be breakeven with less the $30 m cash on hand is my rough guess.
So to maintain that reserve , they will need to make some decisions in 2015.....
Hopefully we will find out more on Thursday.
There is NO sure thing in the stock market .
The sooner you learn that the better
There's an important event that will impact this stock in mid Nov ....the results of the Improve It trial using Zetia to lower LDL
Suggest you read up on that and understand that if that trial fails to show any benefit it increases the chances that the FDA will want ESPR to run an expensive Outcome trial before approving the drug.
ESPR has a lot of potential to offer an effective low cost alternative for those who may be on the new PCSK 9 drugs ( hetero FH ) or as an alternative for those who are Statin intolerant....But we have a long road to travel yet with many challenges ahead
Just to be clear
Even tho I doubled my long position last week I am NOT advising anyone to do like wise .
It's a small high risk position relative to the rest of my portfolio ....it's $ I can afford to loose .
Let's look at the + vs - of a long position at these levels
The -ve. ....AZN can get around Amarins patents and launch Omthera
..... Amarin is forced to dilute to get to at least interim analysis
The +ve ....Amarins patents hold
... Amarin finds a way , as you mentioned above , to get to interim data without a serious dilution
....sentiment is so negative on any prospect of success ....look at how many of the super bulls ( Harvey etc ) have disappeared ,
....scripts are still increasing and they have been able to reduce expenses ....cash reserves will last longer. ....Reduce it is almost fully enrolled with a good chance of being stopped for efficacy before or at interim analysis
Other posters ....feel free to add more +'s and -'s .....we all benefit if we are aware of both sides
Instead of bashing Swalchie ...how about laying out a plan on how we make it to Reduce It Interim data without diluting .
Sales growth is not fast enough to finance us to interim data ( mid 2016 ) ....so what's are the options for raising funds and cutting expenses .
For those who suggest that we increase the sales force . Problem with that is that you spend a lot of money before you see payoff ...so that may no longer be a viable option .
Before anyone sees this post as a soft bash ..I doubled my position when the stock hit 90c
It's $ I can afford to risk . I'm betting they will find a way or partner to get us to at least Interim data
IMHO , Amarin is NOT a viable company without Reduce It .....and Reduce it must be stopped for efficacy either before on at Interim analysis for Amarin to have a future.
Amarin will never make it on the Marine ( very high TG 's ) alone
Reduce It costs decline starting around now ...almost fully enrolled , no new sites being set up or marketing to recruit patients ....it's basically on auto data collection ( periodic blood sample and event recording ) now.
No mgt will end this trial so close to an interim analysis data read out