Well the question on dilution has been answered .
Now on to the Improve it trial results ( mid Nov ) and the FDA's decision on whether to remove the partial clinical hold
Well Will I'm sure his wife and children will appreciate your heart felt ( rather then your brokerage account ) concern .
Show some respect please .
Life is not easy for the children that grow up without fathers ( speaking from personal experience )
NG. Yes I believe that's the case up to 20-25 % efficacy .
So with 15% efficacy from adding Vascepa ...we are expected to hit a total of 957 ?
events around end of March 2016 and trigger an interim analysis
Data monitoring board looks at the data every Qt .....so if at that pt if the efficacy is between 10-20 % I would expect them to keep going until the predefined event number is hit
However ...if efficacy is less then 10% they may suggest to Amarin to stop the trial for lack of benefit ,BUT if they see an efficacy rate of 25% by March 2016 data , I would expect them to recommend stopping the trial for efficacy ..
The biggest question for me is how to make funds last to March 2016 . I 'm not confident in Biwatchs sales/ revenue expectations
Suggest you all read Biwatchs analysis on Seeking Alpha
Very thorough and in depth analysis of the bio stats involved with the Reduce It Trial.
Some what of a rosy scenario view IMHO of the cash and sales going forward ...but hope he is right.
For AMRN to get anywhere near his stock price projections we need Reduce It to be stopped for efficacy at interim or earlier with at least a 20 % -25 % benefit . To get insurance co 's to sign on with generous co pays we probably need benefit to be at 25% as there will always be questions on the placebo and the power ( size ) of the study.
Anyway ..good , educated analysis ...suggest you all read it and comment
" how would data be disclosed " you ask . Every Qt the Data Monitoring Safety Board looks at the unblinded data .....it remains blinded to everyone else . If they see a safety concern ( say cranial bleeding as example ) they will stop the Trial . If they have recorded over 500 events and there is at least a 25% divergence in event lines ....for long enough to be considered highly statistically significant ....they will notify Amarin .
Even if the DMSB notifies Amarin of a 25% separation in event lines I would expect Amarin to keep running the Trial for at least another Qt or to the pre defined Interim Analysis pt because they know the trial will be criticized for being under powered ( not enough patients for long enough )
So bottom line ...chances are we won't hear anything until interim analysis . If Trial is not stopped for efficacy at that pt ....it's the final end of Amarin IMHO .
If it is stopped for efficacy ....$ will not be a problem ...If AZN has Omthera , I would expect some big Pharma to make offer for AMRN
IMHO we will see benefit from high EPA blood serum levels strengthening the caps of arterial plaques making them less prone to rupture . Everyone in RI will have some extent of arterial plaques
Small cap biotech is high risk . Do not invest more then you can afford to loose.
AMRN will never make it on the Marine ( TG over 500 ) market alone ...that's reality . After at least 1.5 yrs on the market they only have about 37,000 people taking the drug on a monthly basis . Many of these are taking Vascepa for CV benefit ( the Anchor indication ) as an off label prescription ...sometimes covered by health insurance .
Amarins Vascepa has always been about the CV benefit from an investment perspective . For that to pay off we need the Reduce It trial to be stopped early for efficacy ...late 2015 / early 2016 ...or at interim data analysis in early 2016 .
So the Reduce It trial must continue until at least interim data analysis , before we longs totally give up on our investment
Getting a Cardio Vascular drug through FDA approval is IMHO a lot more difficult then the days of Lipitor's development . The reason is the failure of such drugs as Niacin/Niaspan to prove enough clinical benefit in Outcome trials .. Niacin was like an early ETC 1002 drug ...did wonderful things to your lipid profile ( altho difficult to tolerate for some ) BUT the THRIVE trial showed that risks outweighed benefits so now its been largely dropped.
As recently pointed out in Forbes ...we have the IMPROVE IT trial with Zetia reporting in mid Nov 2014 .
If the results of this trial are disappointing ( which may be the case because of the population studied ) , then the FDA is likely to want ESPR to start an expensive Outcome Trial before allowing ETC 1002 to be prescribed beyond a very narrow group of high risk patients ...assuming they have made it all the way thru P3 trials with no problems
ETC 1002 has the potential to be a huge selling drug because it lowers both LDL and HsCrp ....but its a long hard road with many hurdles to get from here to there.
Expect the stock to sell off if Improve It data disappoints as it ups chances FDA will want Outcome Trial
The question going forward is removing the partial clinical hold and dilution .
This Co will need $ to run P3 trials , assuming they clear the partial clinical hold ...so its a secondary or partnership .
Once they get thru P3 ...if no serious adverse events etc ...then dont be surprised if the FDA requires them to start an Outcome Trial ( despite what the CEO says )...ie need for more $
So there are risks and hurdles but with that being said ...the data was impressive ...very strong P values ..and more then 1 potential market especially if the Stain / ETC combo data due in Jan comes close to LDL lowering effect of the PCSK9's
Actually high LDL cholesterol levels ..especially 180 and above ..are highly predictive of CAD ( coronary artery disease ) ...so anyone with LDL levels like that would not be prescribed Lovaza.
Lovaza does lower TG's more then Vascepa in the very high TG /pancreatitis risk range .
Where Lovaza dose not outperform Vascepa is in reducing CV risk for mixed dyslipidemia patients ...however proof of reduction in CV events is required by the FDA ( Reduce it Trial ) before they agree to approve Vascepa for this population .
Lovaza never was and never will be ..approved for mixed dyslipidemia patients .
The reason the stock is so low is that IMHO the street is worried that Amarin will run out of $ before the Reduce It trial proves benefit ( ie ..that Vascepa and Statin reduces CV events more then Statin alone )
They will definitely file a secondary ...no idea how big ...so dilution is on the way .
Once they get thru P3 ...if the FDA requires a CV outcome trial ...huge dilution again or a partnership .
I suspect a partnership at that stage
Great data tho ..this is more then just those who cant take Statins
They had the results last weekend .
They don't have to say anything ...they won't have ....but anyone near to mgt would have picked up a " life is great " vibe .
Archie ....well I guess you are short ESPR
Unfortunately I don't own any ESPR ...I researched it and did not expect the results to be as good as they are .
You will need to watch the data on the Statin / ETC 08 trial due in Jan .....if they come anywhere near the LDL lowering of PCSK9's ....then forget PCSK9's once ETC ..08 is approved . The reason is that insurance Co's will force FH patients such as myself to generic Statins plus ETC 08 ....that combination will be a lot less expensive then PCSK9's
So what's the risk here for investors ...well if Improve It trial data fails to show benefit with Zetia later this yr ..FDA is likely to demand Co start a CV Outcome trial before expanding approval beyond Statin intolerant FH patients .....they may demand it anyway .
So you need to look at cash reserves ....CV Outcome trial with 8,000 patients may cost $150m and run at least 4 yrs ....So expect Co to do a major secondary to fund that.
This is a very exciting drug ...but it will have many hurdles to jump before becoming the next multiple billion $ Lipitor
These trial results are great news because the drug lowers LDL and hs CRP
Anywhere between 20-40% of those prescribed Statins , give up on them within one year ...muscle cramping is a concern as well as elevated liver enzymes for some ...also a slightly elevated risk of diabetes.
PCSK9 drugs are more for the hetero familia hypercholestremia ( my lipid disorder ) ...however if this new drug combined with max dose generic Statins can achieve a similar result then insurance co's will push patients such as myself onto ETC-1002 /Statin rathet then paying for the $1,000 a month PCSK9.
So there will be multiple markets ...those who are Stain resistant or statin intolerant , those who can tolerate statins but still dont get LDL to target and those with hetero FH who just dont want a sub Q injection once a month
The results a surprising good. Dr Ballantyne ( investigator in the trial ) has a huge reputation ... clinical data ( P values etc ) look excellent from first glance ...haven't read up yet on adverse events ( cold like effect for some ) so thats some thing to watch . Also chk cash on hand for Co ...they will have to run a large P3 trial and may be required to start an Outcome trial eventually
Great news ...unfortunately I dont own any of the stock ..data was a lot stronger then I expected
The Reduce It trial is almost fully enrolled
If Vascepa plus Statin is 25% better then Statin alone ....we should know by early 2016 ...interim analysis .
Co has funds to last till then
If V is 25% or better I believe the DMC will recommend stopping the trial for efficacy .
So it ain't over until V fails to show Outcome benefit
Full disclosure...I have a very small position in AMRN . I think the FDA's hard nosed attitude towards a very safe drug ( Vascepa ) that will likely show benefit ..is very disturbing ...and makes the company's survival questionable.
Some MD's , more educated in the field then myself ....expect Vascepa to show enough clinical benefit in the Reduce It trial ....for the trial to be stopped for efficacy before the Co runs out of $
I hope they are right ....for patients as well as those still long AMRN
Well I see you and Chuck are here for the first time
So about PCSK9 ....these will be Sub Q injections and expensive ...over $1,000 a month I'm told ...and mainly for those with Hetero FH or who need Statins but are Statin intolerant .
Really ,very little to do with Vascepa , however if Reduce It Trial shows CV outcome benefit ....expect everyone on PCSK9's to also be on Vascepa
Your first post with us ?
So before you launch into your sale of dietary supplements
" no study demonstrates CV benefit of EPA " ...actually there are many ...if you do a simple Google search thru the Journal of Cardiology , Medscape etc "... The question is ..Will these benefits be seen in an "at risk " population on optimal Statin therapy to translate into reduced CV events...ie fewer heart attacks ......ie Reduce It Trial
PCSK9's will be for Statin intolerant patients ...particularly the hetero FH population ....they will not compete will Vascepa
Now please proceed with your dietary supplement pitch
Please " Script etc is an irreplaceable surrogate of outcomes " .is nonsense ..chk the history of Niacin / Niaspan
Outcome trials using Niacin showed risks outweigh benefits despite years of solid scripts
The problem with the dietary supplement biz ...is that they have guys like you trying to sell the stuff
May I suggest a course in marketing.
Your approach encourages everyone to run ,not walk ..away from anything you are trying to sell .