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
Been following this from afar. Am I to understand the CEO made a planned sale? Then almost immediately afterwards Eisai doubled the sales force for Belviq and the result is a 15% decrease in stock price? Goodness, the doubling of the sales force dwarfs that insider sale in importance for the prospects of this company. I understand the growth of Belviq has been slow, but that's to be expected with a rather tawdry track record for weight reduction products in the past. That will almost certainly change. This appears to be a stock in free fall right now for all the wrong reasons.
The CEO 40% sale indicates there is no known bad news on the horizon. Otherwise it would be considered insider trading. Also, Adam Feuerstein's contention this is the death knell for an Eisai buyout is poppycock. If the CEO sale was based on that information he would risking jail time. The sale could actually be indicative of upcoming buyout talks. With Eisai's doubling of the sales force and re-launch of the advertising campaign, they are definitely putting this in the category of "in play". Perhaps the sale was done because there may not be any ability to buy or sell the stock once these talks commence, which would mean the CEO would have to wait for an indefinite period to get access to funds he likely needs in a certain time frame.
Anyone know why AMRN has not pursued hemodialysis patients? Pure EPA resulted in a more than 80% decrease in heart attacks for this population in a 2 year Japanese study. That population by itself represents a huge divergence in sales from current paltry numbers. Just wondering? The FDA probably thinks that's outside the flat earth arguments they spew.
Just want to provide a public service announcement to all the new bulls here. The FDA pulled an obscene act at the Advisory Committee and by subsequently nullifying the SPA. They stopped the safest drug available for high triglyceride sufferers that is the ONLY drug available that does not raise LDL-C on statins. Vascepa also has properties for reducing inflammation that the FDA completely ignored. The FDA will likely say no again on January 15th regardless of what you have read. I love me some Vascepa, but those criminals running this gov't agency are only interested in large pharma concerns it seems. Best of luck. Just a note of caution from someone who lost everything. Hedge your bets.
Okay, this again. Maybe so. But try to find someone using Vascepa who isn't benefitting remarkably so, (I have personally documented over a hundred cases myself), then look at the hundreds or thousands of patients who now have afib due to using Lovaza. Look at the side effect profiles of fibrates and Niaspan and Lovaza vs. Vascepa. Look at JELIS. Look at the clean FDA 72 day letter. Look at the companies that benefit from the FDA's decision. I have a friend who will not be taking Vascepa simply due to the FDA's decision as will millions of others. The safest drug available that has a proven study showing great benefit, albeit for those alien Japanese folks, is being withheld simply because it does not benefit the right corporations. Be it greediness or whatever, trying to bring this great drug to the ANCHOR market with its track record seems to me the right thing to have tried to do. Like me, I believe AMRN's management figured on science to rule the day, but what they got were shells of human beings operating like gangsters.
Yes, by the measure of the stock price and wiping out many investors, yes AMRN was one huge flop. BUT, that flop was precipitated by an absolutely corrupt FDA. So, I would prefer if they just said, AMRN was one of biggest biotech FDA scandals of 2013. There is no other explanation, NONE.
If REDUCE-IT is allowed to finish, hopefully, then we have a light shined on the decisions made by the FDA in the present. If REDUCE-IT produces a 20% or greater reduction in adverse heart events then every single person involved in the decisions today has condemned hundreds of thousands of people to death or decreased life quality. And for what? I'm convinced the FDA would like to see REDUCE-IT stopped so they don't have to answer questions in 2015 or 2016 about their actions today. To deny the safest drug in its class, (maybe all classes), that demonstrably helps improve life quality is criminal. It appears simply that the FDA did this in order to make GSK an extra billion or two, which is like something out of COMA. Seriously. Now I can only hope R-IT is either stopped or fails, because if is a success I cannot let the folks that did this walk. I withhold judgment until that day.