Well, I really don't care how AMRN does and it doesn't matter what I think. The only thing that matters is what the FDA does and what they're doing seems criminal to me. THE SAFEST drug on the planet is refused ANCHOR status when the other drugs clearly don't work and have drawbacks? That's criminal to me.
Really? Goodness. Yes, you're right obviously, there are all manner of different endpoints, heck one study shows those figures on the internets. One thing that is indisputable is the % of good vs. bad cholesterol approaches ideal on Vascepa, not so much with Lovaza, and the differences hardly end there. Lovaza shows no benefit to patients with elevated triglycerides and it doesn't really do a whole lot for the patients day to day, although it's better than nothing for some people. There's the atrial fibrulation problem and some other potential side effects that can be somewhat a hassle.
Note that Vascepa has basically zero side effects. Somebody correct me if I'm wrong, but I don't think they know if you can take enough Vascepa to really hurt yourself. Theoretically yes, but they just aren't sure. The blood thinning could be the biggest problem, Vascepa has other effects counteracting this problem, just like it doesn't raise LDL-C, it doesn't thin the blood beyond a certain point. Certainly, ingesting bottles and bottles every day will cause something to happen, it just might be health, but probably something not good. There are very few "things" period you could ingest with abandon where there might be a possibility of no ill effects. Heck, even drinking too much water can kill you. I think NOTHING else could you say that of, only V.
But wouldn't anyone who had elevated triglycerides prescribed Lovaza be better off taking Vascepa? Same goes for Niaspan and Tricor. I mean with V you get an elevated mood, less point pain, no flushing, no fishy stuff, reducing triglycerides and reducing inflammation more than all of the other grandfathered in drugs that do nothing or worse. Am I crazy or is the FDA crazy? Both, I know.
The funniest post I've seen. Yes, it doesn't matter what % if you take milk!! Like saying you can take whatever amount of LSD you want, just drink milk with it and dilute the % down to nothing. No hallucinations there. Now that's science. You should be working with the FDA!
Thanks. Yes, there are other ways to obtain pure EPA. However, for most people in the US, the advice they take to care for their health comes from their doctors. When their doctors prescribe Niaspan, Tricor or Lovaza that's what they take. I can talk until I'm blue in the face but I've had no success getting people I care about to use pure EPA. I don't blame those people, nor do I place much of the blame on their doctors. The FDA is the culprit here.
Approve this for the ANCHOR population already. This belongs in the category of FDA gone evil. I believe that some on that deciding panel deserve prison sentences for the harm they've done. It's personal now as I can never be as convincing as the "wonderful" doctors who will not listen to any of the Vascepa hubabaloo. I have a family member now with afib and a friend with several health issues resulting from high triglycerides. Still, neither can convince their doctor to prescribe Vascepa. Why? Because GSK needs to make money and apparently they scratch the backs of those who would abandon their "do no harm" vows, so doctors don't have the go ahead they need to prescribe this miracle capsule.
Reading the most recent scripts versus Niaspan, it shows that Niaspan NEW FRICKIN' SCRIPTS are higher than Vascepa. Really, you don't have to say anything more than that. The FDA is shameless, but doctors should be embarrassed.
Hey Akanz! How do like taking Vascepa after all this time? I like your notes. I find it amusing that the FDA rushed into approve Niaspan, Tricor, all the other fibrates... without much proof that they did much, (just moved the markers). Vascepa, the one drug that does actually do something gets the back of the hand.
Billions and billions sold to .... do not a whole lot. Of course, if your triglyceride levels are way too high, any triglyceride reducing agent is preferable to nothing. So Niaspan and Tricor do help those folks. Vascepa helps more, reducing triglycerides while reducing inflammation and creating a vast array of ancillary benefits neither Niaspan nor Tricor will ever produce. Out of the three, Niaspan, Tricor and Vascepa; it is only Vascepa that has a trial, JELIS, showing a reduction in adverse heart events in patients with slightly elevated triglycerides. Vascepa has the added benefit of nearly zero side effects. So, the FDA is keeping a tight lid on Vascepa because it is too complex, yep, it's a real mystery. Good going FDA, so go approve the next VIOXX because big companies like MERCK are okay to let kill people for a while. After all, the billions in sales more than pay for the lawsuits to follow.
Are you referring to the anecdotal JELIS study and the anecdotal ANCHOR study? Or, the anecdotal way AMRN set up the study to comply with all FDA requirements? Maybe you're referring to all the recent anecdotal study showing a definitive link between slightly elevated triglycerides and heart disease. The anecdotal Japanese study for hemodialysis patients shows that thousands have died anecdotally since the FDA sees the evidence for Vascepa as too complex. When REDUCE-IT does come out with its life saving anecdotes, that probably will also be too complex for the FDA. The simple thing is, giving AMRN ANCHOR will cost big pharma billions, and that's not according to the FDA playbook. Yes, they'll say no, I do agree.
Oh my! Jenkins says the issue is complex. That's a little bit like saying that water is complex. Yes, of course it is if you want to go to the sub atomic level and look for the god particle. Here it is...anyone with elevated triglycerides is looking at the number one killer in the world right in the eye and Vascepa reduces the risk more than any other agent without side effects, with the side benefits of reducing cancer risk, improving mood and healing joint pain. That's how complex this is.
Of course there is nothing quite like Vascepa for curing what ails you, yet the FDA keeps to its dogged dogma. We have a decision coming up shortly and I'm fairly certain I know the result. No dice! To give into Amarin would hurt several larger pharmaceutical companies and that's not in the cards it would seem. Reading the updated literature now on the topic of pure EPA, it makes me very sad to know for certain the FDA is rigged by money and corruption. ONLY a renewed SPA could possibly slightly renew my faith in this agency, yet I'm not holding my breath. By the way, if you or anyone you know is suffering from elevated triglycerides...take some Vascepa. Even if you have to knock your doctor upside the head to get a prescription, they are part of this hypocrisy even if they don't know they are compromising your health.
Shares fell off about 15% once it was learned the CEO Leif had sold 40% of his shares, (not all that many shares and a pre-planned sale, gheesh). Shares hit again by Janet Yellen saying biotech valuations were stretched. Neither event has much to do with what is likely to happen with ARNA. Since then ARNA has seen the sales force for Belviq raised from 400-600 reps and a re-launched add campaign that is packing a punch and is all the place right now. Scripts were way up this morning and likely to increase dramatically over just the next few weeks. An approved patent that bodes well for the future also gets thrown into the mix. Now the stock sits below $5 on misinterpreted information. It's easy, buy the heck out of this company.
Sentiment: Strong Buy
Clearly the pricing is not reflecting the interest today. It just appears like there's a whole lot of buying interest and if it overwhelms these sellers look out, this is headed way up.
Sentiment: Strong Buy
Level II showing an increasing supply of buyers as volume slows, looks like that will break here soon. A few sellers holding this tidal wave back right now. Perhaps the scripts data is pushing this. Looks like a tremendous opportunity to get into ARNA as an artificial barrier is about to break.
Sentiment: Strong Buy