Amazing how little is understood market wide about the full potential here, but it's staggering. Just one little piece of the puzzle to consider. Type 2 diabetics will be the most benefited class by a successful Reduce-It trial. Consider they basically ARE the trial population and every single bit of evidence lately and for years has indicated pure EPA performs miracles for these people. That's not an exaggeration.
Now there are approximately 27 million type 2 diabetics in this country. Overnight, upon a successful R-It trail about 10% of these patients will be switched to Vascepa, and that's so conservative it would make #$%$ Cheney blush. That's approximately $5 billion a month and just a tidbit of the full potential.
Good to hear from you Akanz, you provide personal insight and sanity. Here's the deal, I have this crazy theory, hear me out. So, the more fish people eat the more likely they are to eat less and be more active, unwittingly. I encourage anyone to try eating fish, not battered of course, for a couple weeks, every single day, one helping. No need to try and change the rest of your diet, the fish oils tend act to counteract your worst tendencies. You'll end up eating less and being a bit more active. This won't work for everyone, but for the majority I believe it will. Similarly, Vascepa and better habits go hand in hand, unwittingly. Of course, your doctor is telling you to behave, but Vascepa is telling your body to behave. There is some information as well about Epadel's effects in alleviating depression, it's a contributing factor as well. These changes in behavior and advantages they bestow probably didn't appear very often to participants in Reduce-It until they were given Vascepa. On the surface no one can tell because the doc's give everyone the same instructions on diet and exercise. The Vascepa patients simply carry out those instructions more often. Sorry for the ramble, but that's my thinking on the matter.
Really? I'm crazy, I know that, but dog gone, you're spreading pure sunshine here. The FDA really deserves a kick in the behind and I'm all for that. Never been more surprised or disappointed by people I thought were above blatant and provable disregard for human decency. My point is Vascepa doesn't have any side effects to speak of, the only risk in giving it to ANCHOR patients was people would feel better over time with less side effects and some large pharmaceutical companies would make less money for a few quarters.
Ah Swalchie, we meet again! Here's my take. The trial will be stopped immediately if there is overwhelming efficacy and we'll find out about that right away, (if it exists). Compiling results is a much longer term proposition, but knowing how many CVD's there were with V vs. placebo is a simple calculation. The never ending gains in market share should be kind of a signal here. The benefits are already being seen where doctors signed on for early adoption, but the FDA has put a blanket on those voices. This first amendment thing might be the Trojan horse way AMRN has to get to the very real human results that exist today. Those early adopting doctors aren't allowed to speak and I know what they're seeing, it's night and day. Vascepa creates happier, healthier human beings. The FDA's actions have been despicable, yet money is what moves society and they're not immune.
The closer one gets to the interim trial results, the closer one is to a report that could set the biotech world on fire. Much like entering the even horizon of a black hole, AMRN's Reduce-It interim results are inevitable and will be pulling the stock price higher.
Many have made great commentary here on why Reduce-It might be a failure, or not as successful as hoped. I'm pretty sure they're wrong.. The Japanese live 5 years longer than Americans and are far healthier. It is assumed, and I believe rightly so, that the Japanese diet of fish is the culprit. In JELIS all that was done was to add some EPA on top for these Japanese folks, and we generally saw a 20% reduction in CVD after some 5 years. That 20% reduction is on top of also being far healthier in general than those in the Reduce-It study. The Reduce-It folks don't have a heavy fish diet to begin with and none of that protective diet to help them in the first place. The heavy dose of EPA provided by Vascepa will not only get them to the 20% reduction, it will introduce to the patients the very best fish oil has to offer, and they'll gain much of that 5 year mortality difference to produce some hugely favorable results in my opinion.
So, the interim trial seems scheduled for early 2016 and here we are just a little over a half year away. The overwhelming evidence you can find on the AMRN website of new studies indicating more conclusive results than ANCHOR produced should point everyone in the right direction. We are coming close to the sun, those interim results, so don't surprised to see the stock price start galloping higher with no news, and pretty much from now on.
This is what the FDA uses as an argument against Vascepa being given ANCHOR approval based on the very in play mixture of ANCHOR study resutls and Jelis anecdotal evidence.. Japanese eat way more fish, so the 20% reduction in CVD was only because the Japanese were stuffed to the gills with EPA to begin with and needed that for the extra EPA pill to ignite the drastic improvement, (that's the FDA stinking thinking). Westerners don't really eat fish so they have little or no EPA in their systems, so the EPA pills will have almost no effect. That's why Vascepa is not being prescribed to everybody...it's the Adam Fraudstein argument that people that never ingested EPA won't benefit from taking huge amounts of EPA every day, while people stuffed to the gills with EPA benefit because they're stuffed to the gills. It's insane.
Judge Moss basically said the FDA was misguided about NCE guidelines in his comments regarding "active ingredients", yet that doesn't mean AMRN will win. The Judge is far more likely to side with the FDA for a host of reasons, the most obvious is that they are the FDA, a hugely powerful government agency with tentacles everywhere. If the Judge rules against the FDA that would be strange, but it would be an excellent and just outcome for AMRN and patients . That decision should come before July 2nd one would hope. If they lose this battle AMRN appears to have enough cash to survive through to the RECUDE-IT interim results, but they'll have to file and fight multiple lawsuits judiciously. If you've been reading the Vascepa story you're probably aware the REDUCE-IT trial is big and with each passing day ancillary evidence indicates it will be successful far beyond trial parameters. By the way, that's why the FDA's long delay on the NCE decision and also the ANCHOR advisory panel denial should be rescinded. The evidence against mineral oil being a problem with LDL measurements has been shown to be a moot point. Vascepa is one of the safest drugs to take and it reduces triglycerides quite well, so what's the harm prescribing it over other drugs that actually have things like arrhythmia, (Lovaza), and kidney failure, (TRICOR), associated with them.
Well, the interim Reduce It trial results should take place in early 2016, (at least that seems to be the consensus). Those results could be among the most celebrated results for any drug since Lipitor. I'm not sure how many people on this board realize that? The amazing thing these days is the growing market share for Vascepa. If, as the FDA has suggested by their rulings, Vascepa no claim to advantage over Lovaza and Tricor, etc..., then there is NO REASON IN THE WORLD VASCEPA SHOULD BE GAINING MARKET SHARE. Generic Lovaza and Tricor are way cheaper and heck, they do the same thing according to the FDA. They also are easier to prescribe and easier for the patient to procure. There is quite literally no reason at all, none, for Vascepa to keep growing market share. You might say, they have a bigger sales force now. Doesn't matter, doesn't even figure, it's a pin #$%$ of a sales force. When the drug first came on the scene they had everything going for them, including the promise of the ANCHOR market, and yet the scripts grew at a meager pace, especially after the ANCHOR CC and the huge setback at the hands of greed and the FDA. Now, doctors are literally prescribing something that costs more, has a shorter history of safety and the FDA basically says, it's just another fish oil thing. For doctor's to prescribe it at a higher rate each week can only mean one thing...it works better and doctor's are visibly seeing that now. But there was only a small portion of original adopters and they are the main push behind the constant rise now. Other doctors never truly bought in and won't come along until something forces them too. Reduce-It preliminary results will do that, the rise in market share is telling us that right now.