Vascepa is an astoundingly good drug without drawbacks. Based on JELIS it reduces CVE. The HD study I brought up is just one of dozens of surprising studies showing EPA by itself has wonderful capabilities, even if they aren't all just related to CVE. Vascepa leads to a healthier, happier existence. Yet, the FDA has decided to derail Vascepa with a prejudice that borders on obsession. It looks like they are going to appeal the NCE decision at the last second, putting further strain on Amarin's resources to continue Reduce-It. With the first amendment case the FDA has said that Amarin should have talked to them first, that they would have allowed basically everything Amarin asked, and they are working on updating their guidelines on off-label standards insinuating that Amarin totally jumped the gun for their own benefit. Unfortunately the Judge may have bought some of those arguments and while Amarin may get a piece of crust, the FDA will likely get most of the decision they want. So, bashers and those alike in thought, consider yourselves proven correct. Only humanity suffers while this disgusting charade keeps on keeping. At least the drug companies that benefit from keeping Vascepa down are happy and the FDA members who get board seats and kickbacks can help their families and friends.
I know the FDA thinks that is a dangerous thing, but when the drug in question is safe I think HD patients would benefit regardless. Vascepa improves mood, reduces joint pain, calms you and helps you focus. What is the harm? It seems there us way more potential harm for HD patients avoiding EPA.
Little did we know 90 days ago that the OIG was shaking down docs and granny about taking the illicit drug Vascepa off label. I don't expect much relief in these numbers until after the Judge rules, unless he goes with the FDA. Seeing the HHS OIG go after Vascepa so specifically with their monstrous 12k script level is worse than fiction. I cannot believe them.
It's particularly relevant if you're a hemodialysis patient, but no one from Amarin can ever mention the relationship. Amarin can't tell you that you can reduce the chances of afib by switching from Lovaza to Vascepa. They can't tell you anything except that it reduces triglycerides in people that have triglycerides over 500 mg/DL. I think being able to talk about an FDA approved and validated study such as ANCHOR isn't asking too much though. Don't want to get crazy and improve someone's chances of living by 80%, heck no.
Lovaza works, but isn't well tolerated by many HD patients. Vascepa is only approved for high trig patients so if they ever mention this study to a doc it's jail.
In a study of 179 hemodialysis patients given EPA for two years, 11 cardio deaths and 27 cardiac events were reported in the control and 2 cardio deaths and 13 cardiac events in the intervention group. Study conclusion: EPA significantly contributes to decline in risks of cardiovascular morbidity and mortality in HD patients independent of triglyceride and C-reactive protein reduction. European Heart Journal 2013
Ethyl EPA does well. It makes you feel a bit calmer For many people that's a difference maker. It helps when you have to wait for Judge Engelmayer. It's not his fault first amendment cases take so long, but Vascepa makes it hurt less.
Cynical read. The approval for super high trigs 2000+ mg/DL is baked in and those folks need something right away. My assumption of more approvals is based on the huge market cap. The FDA has made no commitments yet and it'll be at least a few years before they approve it for very high tech trigs. I'm just absolutely disgusted with that agency. The HHS OIG report reminds me of Colin Powell testifying before congress bringing about the second Iraq war. Just the govt perverting facts to get their way. It's so obvious.
Oh, I might add that our genetic code is similar to all other living things including things like trees. While scientists have figured out the primary function of each gene, they don't know much of anything about junk DNA. Honestly, playing with genes is playing god and even a quantum computer cannot tell you the possible effects expressed years later after "silencing" one of these things. Think Re-Animator.
The antisense RNA gene silencing triglyceride and apoC3 reducer is about ready to get FDA approval soon. We have no idea what silencing a gene will do long term, but heck that company is worth $5 billion without sales now, because it "cures" super high trial levels. Our bodies have only so many genes, but they control trillions of bodily activities. Silencing them at all is a bit like playing Russian roulette. Maybe tour eyeballs fall out in 5 years, or your hip bone disintegrates. But the FDA is with them all the way.
You mean we can't sue for losing in some cases a life's fortune? This means the Judge thinks that Amarin was above board and really thought a drug with no serious side effects and a successful FDA trial and a benign 74 day letter was going to get approved? Of course I'm being a bit sarcastic. The FDA is the guilty party here and holy cow are they guilty. I've said this before and I'll say it again. Even if Vascepa fails to improve outcomes, approving Anchor would have been a vast improvement over the current situation.
Reduce-It has some chance of being successful. What is that % chance of being successful? If the chance is close to 50%, which is pretty low considering the trial design and JELIS, then what the FDA has done and s disgraceful. Oh right, that's what it is. Avandia anybody?
Holy smokers, I get a thumbs down for just being. You are pretty consistently blunt and that just invites those thumbs Swalchie. You still think your friend is right about the case being lost?
Akanz would tell you Vascepa is one of the most patient friendly drugs. It pleases its users and is what all other fish oil pills wish they were. It really is the dream that omega-3's once conjured in the national imagination.
Reduce-It may be the do all end all, but this case is incredibly important and will be game changer news if Amarin wins. If they lose it's anticipated. I think they'll win. I thought the 6/30/15 Amarin response was enough but the market is just determined to follow conventional thinking. This isn't a conventional case. It isn't tiny AMRN v. FDA, it's Historically Towering Free Speech Attorney with precedent and the perfect case v a bumbling delaying uncertain embattled agency that done very wrong and they got caught. The laser focus on the 1st amendment was staunch considering the FDA tried to open every avenue for delay.
Market obviously siding with FDA argument. Hard to argue against them since the FDA almost always wins. Only saving grace is Engelmayer's past rulings indicate he's a first amendment proponent and he seemed excited to see Floyd Abrams. Oh, and Amarin's arguments on paper and yesterday were very strong with no holes the Judge could find.
There is nothing in the FDA's basket of talking points to make REDUCE-IT go away now, although they'd sure like it too. They tried mightily with the about face on ANCHOR, nearly causing the study to be scuttled. ACCORD, HPS-THRIVE AIM-HIGH used patients with baseline trigs around 150 on average. HOW ON EARTH DOES THAT QUALIFY AS A REASON TO DOUBT REDUCING TRIGLYCERIDES IN THE 200-500 RANGE WON'T HELP REDUCE CVE?????????? There is no real comparison and locking these trials into ANCHOR and what R-IT might do is the worst kind of theft in the history of theft. Vascepa would be doing billions of dollars in sales right now if ANCHOR had been allowed, but the FDA thought that niacin and fibrates would have the lions share of the market by that time. When their unrelated trials failed, Vascepa was going to get it all and that would hurt some of the FDA buddies feelings, because they needed that money for themselves to share with the FDA in certain ways and favors. In the meantime, as many as one million people may die prematurely because these FDA buddies needed their money. Here we play a game with the FDA again and they won't budge an inch on giving Amarin any relief in this first amendment case, even with several studies, (including the failed studies listed above that showed some benefit for sub-groups with high trigs), showing quite beneficial effects on reducing inflammation and Vascepa does it without side effects. The sickening argument the FDA used yesterday saying Vascepa isn't safe in the ANCHOR population because it isn't effective misses the more than decade long use of Epadel in Japan for the high triglyceride population; entirely safe AND FLIPPIN' effective. It's a pity that there is any chance Amarin would receive less than the ability to market truthfully things that would help many people. Fortunately, Amarin chose the best in the world to represent them and that might be enough, it's certainly better than just continuing to lose patients.
Sentiment: Strong Buy
From the Stumbling Bear account, Judge Moss and Engelmayer, it seems to me, had similar reactions to the FDA's arguments. Those Judges just didn't buy anything the FDA was selling. Seems very promising.
Sentiment: Strong Buy