Re test results available in 2010 . I believe you are talking about the ACCORD-Lipid trial 2010. The median TG level in that trial was 162 .....Not in the Anchor indication of 200-500.
There was no benefit seen in this group HOWEVER in the sub group of patients with both TG's over 200 and HDL cholesterol under 40 , there was a 28% reduction in CVD risk
So ...most benefit IMHO will be seen in this sub group ..high TG /low HDL ...the question is " How much benefit once patients are at optimal Statin therapy " ( which is defined as getting LDL cholesterol to 100 )
This we won't know until we get some Reduce it trial data
The Anchor Trial was not designed to measure reduction in CV events ...it only lasted 12 weeks I believe....so how could it be "indicative of the efficacy to reduce CV events " ?.....it measured the efficacy of lowering high TG's for those on Statin therapy WITHOUT raising LDL. cholesterol
Would be nice but I suspect they have just approved the label change ( re nursing mothers I believe ) ...approval of the Anchor indication any time soon , still looks like a real long shot IMHO ...altho I think they should . Vascepa is a very safe drug and Doctors and patients should have some choice here
We need to have 967 events ( 60% of the 1,612 events expected by Dec 2017 , if Vascepa has no effect ) before we have an interim analysis ......that would be about Dec 2015.
So , If Vascepa IS having the effect we expect , it will take longer to get to 967 events and therefore the interim analysis will happen well after Dec 2015.
Is that correct
I think they will do everything they can to survive until the interim data analysis ( 900 events ) expected late 2015 .
They have I believe about $200m in cash. Mgt can cut salaries by 50% in exchange for options etc . They can talk to the FDA about ending enrollment at 7,000 patients ( I'm not an expert here but I believe you can get great data from 7,000 patients instead of the 8,000 planned on) and so on .
There are things they can do to conserve cash.
When the interim data is released , if Vascepa is working as we hope , event lines between the two groups will have diverged enough to hopefully be stat significant ....at that pt we should know if we really have an important drug or just expensive fish oil.
If Vascepa is then showing strong clinical benefit , Amarin will be in a very powerful position to negotiate partnership deals.
Good post ...Reduce It answers it all ...which is why it MUST continue . If Reduce It shows stat sig clinical benefit ...particularly in "hard " events like heart attacks it will be a huge game changer .. If not ..well then Vascepa is still a good drug for those with very high TG's and high LDL ...but thats a small market and not worth owning AMRN for.
The issues some have with Jelis is that it was open labeled , 58% postmenopausal Japanese women and LDL lowering was not optimized ( ie statin dose not strong enough ).
By contrast Reduce it is double blinded , over 60% American , LDL levels under 100 and TG's over 200 --its a much stronger trial.
My only concern is that I hope the FDA doesn't use the mineral oil (placebo ) issue to question the results if the trial is successfull
Well its nice of you to say I may "share decent information " but honestly I did not expect the Adcom to deny Anchor . The opinions I had ...even from a Prof /Scientist in the field at UCSF was that they would approve simply because it was a SAFE drug that MAY show clinical benefit...there was no downside .
Where I agree with Siggy is "that lack of direct reference to lowering TG's in the new guidelines " I only see reference to treating very high TG's NOT TG's between 200-500.....so on balance I see the new guidelines as unfortunately a negative ...at least until we get some Reduce it data
Thanks Cincy ...sorry I don't know anything about the Co.
OT HALO and PCYC are my biggest B Brothers holdings plus some ACAD
Oh common on now ..I wanted to tell the EM doc that Butlers told me to do it ...take 200x 4 Ibuprofen
Actually i was going to write " What ...I just took 200 x 4 .. and NOW you tell me .etc " : )
butters ...not sure if I'm following your line ...but really , if you are really "at risk " ...family history , stents , diagnosed CAD ...go with RX grade Vascepa if you can get a scrip and its priced reasonably with coupons .
Frankly DS versions at less then 4 gms a day are questionable .
Besides ..according to the AHA ...we won't know if Vasepa really works until we see Outcome data
How do you know BBrothers took a 19.9% interest in MRTX. Please confirm
I follow them
Butters ...If Reduce it shows a reduction in heart attacks ...even if the interim analysis after about 900 events ( expected late 2015 ) shows a stat sig divergence in event lines ...Vascepa will be huge
No one , in my experience , likes Statins . Muscle cramping and short term memory loss are real issues as is concern about increased risk of cataracts and diabetes .
Vascepa is BY FAR the easiest to tolerate of all the lipid altering drugs ... IF it demonstrates a reduction in hard events ( heart attacks etc ) ...it will be huge ...which is why I still own the stock .
Did I mention IF it demonstrates ....you get the picture
I have to say I agree with you on your original post ( JL is a real MD IMHO by the way ) ...anyway ...what stunned me about the new AHA guidelines is their total reliance on Statins and lowering LDL ...based on the outcome trials they reviewed.
The Lipid Assoc ( not correct term ) is not buying into it but the IMHO Cardiologists will follow the AHA line ...it provides "cover "
Re Shortfish ..hey give him credit for cataloging so many shorts ( who unfortunately ..often for the wrong reasons ...have been right )
XXX well thats fuuny ...I have high TG's ( if I'm not on max dose statins ) and a friend is currently under going chemo for the type of cancer that PCYC stops ( or at least reduces ) .....so from a front line experience ...they are worlds apart
Consider yourself blessed if all you have to worry about is high TG's
When you look at the next GSK report ..its very unlikely that Lovaza is doing $1 billion a year ...and as regards to AZN paying $440 mil for Epanova ...well consider that 95% a write off
Suggest you look forward ...not backwards
Geez Butters ...you are actually making some sense ...other then that its the AMOUNT of EPA that matters ...suggest you read " Omega -3 Fatty Acid Blood Levels : Clinical Significance ...etc "
Yes Harvey ...and you need a well designed DOUBLE BLINDED outcome trial with most American patients showing reduction in HARD events to convince the AHA and cardiologists of the value of Vascepa .....so we wait, at least for Reduce It interim analysis.
By the way IMHO the value is not some much in lowering TG's but improving the EPA/AA ratio
Harvey ...I usually ignore your posts as they tend towards the hyperbole and conspiracy pt of view .
However ...in case you haven't realized it yet ....the AHA ( and by extension ) many Cardiologists want hard data ....ie double blinded well designed Outcome trials ....so until we have hard data from Reduce It ...we have practically nothing other then that Vascepa is better then Lovaza for those with very high TG's
Perhaps I should repeat that ....the new guidelines basically say that unless you can prove thru well designed , double blinded outcome studies that your drug reduces " hard " events ( ie heart attacks not angina ) its not worth much.
And before you say I don't know what I'm talking about ....I've been in a CV clinical trial . taken more statins at higher doses for longer then most alive today , taken most of the other lipid altering drugs , and am married to some one that has prescribed Statins, Lovaza and Vascepa
Oh and by the way ...I own PCYC ---have owned it since May 2012 ---and you clearly have no clue about what you are writing .
Sorry Cincy but the AHA guidelines are likely to be the rule of the land until hard data from Reduce It proves otherwise ...and yes I take Vascepa and own AMRN ....but I'm being IMHO realistic
AMRN is currently priced as an option on at least Reduce It interim data ...due late 2015
Swalchie ...you have become very readable . I enjoy your pots . Sorry to say ( as I own AMRN and take Vascepa ) ...the powers that be ,have apparently decided that only Statins and lowering LDL cholesterol matter ...at least until Reduce it results .
Glad you are observing from a perch above the mess .
The top mgt takes a 50% cut in salary ...Joe Z is not worth 800K a year ..you cut expenses and you fund Reduce IT thru to the interim data analysis late 2015.
If there is no divergence in events lines in late 2015 THEN you drop Reduce IT.
IF there is a stat sig difference in event lines , you partner with a Big pharma
( From an ex CEO )