Fact is the study had been circulated on StockTwits PRIOR to AdComm. There were ppl who even forwarded the study to both the Company and the FDA. Why the company never brought it up? Who knows, maybe they never cared to read the stuff sent to them. Either way if you want to read the study google: "advpub_18002" it will be found in the Journal of Atherosclerosis and Thrombosis.
Besides the science there is a very strong public policy argument as to why the FDA ought to approve this new indication while REDUCE-IT is underway. Prior to the start of REDUCE-IT the FDA was lacking any real definitive study on the effects of EPA on cardiovascular risk. All we had up to that point was what is currently in the briefing documents. The FDA needed a study that was on point to the issue. Studies are expensive and pharmaceutical companies are unwilling to undergo a long and expensive study without some ability to mitigate the risk prior to the completion of the study.
Hence the FDA who needed the study and Amarin who wanted Anchor to help mitigate the risk of REDUCE-IT came to a partnership of sorts. The original SPA was premised on this idea of being mutually beneficial to all parties. If Anchor is rejected it is unlikely that another pharmaceutical company will ever enter into a similar agreement with the FDA knowing that at the end they may simply back out of their agreement. In order for industry to continue to fund and conduct long and expensive outcome studies the FDA must help mitigate the risk involved . The FDA risks losing out on beneficial research in the future if Anchor is not approved.
One price for positive another price for negative. Offer doesn't isn't official until the end of AdComm vote, thus bypassing SEC regulation in terms of informing shareholders.
Is there a possibility where the AdComm votes negatively due to what ever reason, but the FDA approves the drug in December because of the SPA? That would be one wild ride for the stock price if that were to happen between Wednesday and late December.
Dr. Bittner seems to have done extensive research in the area of cardiovascular disease and elevated lipids. Just google her. However, although she is on the committee, she will not be on this particular voting panel that is to determine Vasecpa's fate on Wednesday.
Can you endorse V for the Marine indication? Based on your logic you wouldn't be able to yet, it is approved for that indication. Was tat a mistake on the part of the fda?
IMHO if we get neg rec it won't be because of the placebo it will be because we can't show V decreases CV events.
The "Treatment Differance" is what matters in the first chart. If the placebo is off than you would get a skewed treatment differetial.
I agree with your interpretation of the first page chart. You are correct baseline was zero for that chart on page one. But read my post on "Analysis of the (in)significance of mineral oil placebo." You see the number that truly matters is the number comparing V+Statin to Placebo+Statin. Why? because we already know that statins decrease lipid profiles what we are trying to figure out is how much better is adding V.
Has nothing to do with the placebo effect. The problem is the baseline may be off when you use a placebo that is not totally inert. Since you are using a statin the baseline is not zero.
a) the companies job will be promote the studies that have shown EPA/Statin therapy to be beneficial in decreasing CV events(ie JELIS) and to discount studies that have shown no benefit. You are correct that many of these studeis dealt with patients that had trig levels lower than 200 in addition to takin a dose of EPA less than 1g. These are all concerns that the company must point out in order to successfully link EPA to a decrease in CV events. They don't have to prove anything Wed but they do have to at least make a damn good argument.
b) f it were just a lipid reducer and not linked to CHD than yes slam-duck approval. God question not really sure why it wasn't presented to the FDA as just that.
I don't think the committee will automatically dismiss the measurements outright. The question is how much "off" are these measurements and whether after you account for the possible "over-estimation" is V's efficacy still statistically significant.
The fact is this issue has been presented in the past with Marine and the company was able to dissipate the FDAs concerns. I don't understand why they wouldnt be able to do so again with Anchor.
After a careful reading of the FDA briefing documents I believe there is quite a bit of misinformation and general lack of comprehension on both sides.
First and foremost we must realize that the Anchor study is a combination study involving V and a statin. It has already been scientifically proven that statins will LOWER an individual’s lipid profile. One question the Anchor study attempts to answer is what is the effect of adding V to a statin treatment. In order to determine a baseline for comparison the statin is paired with the placebo. In theory the placebo used should have zero effect on the statin. Unfortunately this is NOT the case in the Anchor study. The FDA briefing documents reveal that a Statin in conjunction with a placebo (mineral oil) INCREASES an individual’s lipid profile. Remember it has already been proven that statins decrease a person’s profile not increase. Therefore it can be inferred that the placebo is not inert. It is likely that either the mineral oil placebo increases LDL or the mineral oil prevents the absorption of the statin.
What does this mean about V plus statins efficacy? Well the only thing that could changes is the baseline the statin plus placebo was supposed to create. The placebo does not in any way effect the efficacy of V. However it does affect how efficacy is measured. The decreases in lipid profile still happened. However, the comparison to statin + placebo may be off. By how much? Who knows…
I still believe the more important question is whether V plus statin causes an decrease in CV events. Not just lowering lipid profile but actually preventing a heart attack. I have yet to see anything in the briefing documents to suggest that the current scientific knowledge is insufficient in providing the committee with a sufficient amount of data to make an educated guess prior to Reduce-it. In the FDA briefing docs pages 64- 94 do a decent job of incorporating JELLIS and other literature on the issue.