Here's the deal. Vascepas is about equal to Lovaza in reducing triglycerides, but V is far better in reducing inflammation, plus it doesn't increase LDL-C, (bad cholesterol); whereas Lovaza raises it upwards towards 40% in some patients. Vascepa doesn't contribute to an increased chance of developing atrial fibrillation like Lovaza admits on its label. Lastly, Lovaza has no claim to reducing CVE and no hope of being ever given that distinction, yet Vascepa may. It takes ONE sane person at the FDA to change this rather disgusting madness where we dole out Lovaza to 7 times more people than Vascepa every week. It truly is madness. Even if Reduce-It fails to produce any meaningful reduction in heart disease at least everybody taking Vascepa would be better off due to fewer side effects. If Reduce-It is a success, then we're just wasting time and rolling the dice with people's lives because the FDA was embarrassed that Niaspan turned out to be strong delayed niacin which nobody really thought was a great idea to take over a long period anyway.
Yes indeed. The thoughts of the earliest excitement, the combo pill. Well, that might grab some share in Europe when interim gets stopped, if it does. Heck they might pull that lever in Spain tomorrow, who knows, this isn't a helpless little company.
If you show a doc Anchor data you are showing them information similar to fibrate and niacin data. The numbers are about APO B and non- HDL and such whereas the other drugs in this category also had positive impacts on various lipids. All doctors see is another drug that impacts different numbers. Niaspan had some of the most promising numbers, so Anchor data probably isn't moving scripts much. On the other hand Jelis data is about health outcomes not so different from statin data that caused a revolution in treatment. That might make a difference when the reps show those remarkable graphs.
Oppenheimer's note was very positive, it was that and likely not Cherry results that caused the AH bump. We've known for years that pure EPA wipes away arterial plaque, it's not new information and Japanese studies mean nothing to the FDA. The JELIS results will help increase scripts some. Deals to sell V overseas will help, but the time between agreement and payments will do nothing to stop the company from needing to dilute again. That said, I'm firmly in the camp that interim results should show extreme efficacy and may stop the study. The JELIS graphs are stunning in their geometric rise in CVE improvement and the sub group improvement, if applied to the Reduce-It population should provide a graph even more stunning than the overall JELIS population. Throw in the double dosing and the fact these patients in R-It do not have the initial benefits of eating fish all their livesvand you have a haymaker interim lined up. Barring that, this goes until 2018 as a stock that'll drift around this level for a long hard slog.
Swalchie, I must admit this does seem to be coming down to REDUCE-IT only. Nothing else seems to matter. Congrats, you've been right all along. Of course, the fate of Amarin is heavily influenced by those results good or bad. Possibly my largest failing is looking at the JELIS graph and extrapolating to REDUCE-IT. The 20% reduction seems to be consistent and growing exponentially over time. I figure the sub-group would have looked much the same with a larger sample size but showing a larger success near the 50% level. At this point in time, the trial in my mind is already a fairly large success, so I want them to take a peek. The alternative, barring any FDA gifts, is a steady loss of reserves and another dilution, hurting any potential upside. At $2 a share to raise the $150 million or so they need, the reduction in share value would be horrendous. Oh well, that's my thought on the matter.
2016 is when the company "figures" interim. They have not ruled out anything else according to their language but it's pretty clear what they think. So no need for lawyers. Boulder, of course the longer the trial takes to get to interim the more likelihood there is for success. All that said, the most likely time for interim is 1st quarter 2016, basically because the company has also said the final event should occur in 2017, again not cause for lawyers. Sorry for suggesting an early look, apparently it hits a nerve. It has become apparent that without a label change, Amarin sales are going to move up slowly because of insurance pegging Vascepa at tier 4 and generic Lovaza being passed off as generic V by shadowy practices. That will continue the financial bleeding. I ask myself what on earth can stop this nearly guaranteed disappointment of quarterly losses? Well, a deal where V gets a label expansion is one of them and the best one. The FDA's "reason" for not giving ANCHOR rests on other failed trials of non-related drugs and the current "consensus" that lowering triglycerides does nothing. They appear unflappable on this; however, back in August they agreed to work with Amarin and try to work on a settlement, (apparently to make the 1st amendment thing go away). This Possibility of Settlement is a conundrum. What can the FDA offer? They don't want to give Amarin anything and they don't want to lose the 1st amendment case as doing so opens up a Pandora's box of lawsuits. Sitting right beside all this is the Reduce-It trial, within about 6 months of an interim look. If Amarin is to get a label expansion, it seems to me the FDA and Amarin could come to a deal and look at the trial without interfering with interim or final analysis. They could say if the results indicate the trial can continue that Amarin will receive some label expansion, but if there is no sign of effectiveness, they can shut it down. That saves us from ourselves and this agony.
They did say 2016 actually, call them. You are right, looking early would be counter productive it seems, I just hate to give the FDA more time to scheme.
The problem with your dim witted rant is interim occurs at a prescribed event number and final analysis occurs at another number. According to the company, interim will occur in 2016 and final in 2017. The only way that's mathematically possible is if interim occurs in the first quarter or early second quarter of 2016. Interim may not stop the study and it doesn't ruin the study so an early interim can do the same thing.
Had to say something, it's dead in here. I'm not understanding the repercussions though. We are within 6 months anyway, what's the big deal? It's similar ramifications now or then.
Oct 30 is coming. Easiest way to settle would be to peek at R-It. At this point in JELIS the sub-group improvement was over 35%. With over 100 events to go b4 interim, Amarin is pretty certain they have all the cards.
Akanz, thanks for the insight. Diluting isn't the end of the world but it shouldn't be needed. Strange FDA decision today removing a warning against Pacira, showing a reverse of all previous behavior. That could be a good sign, who knows.
Your experience explains why Amarin is going to ask for label expansion, likely revealed Oct 30 or after another delay. I didn't get the impression the FDA wanted to mess with Floyd Abrams at all. Giving Amarin the first amendment Anchor reveal doesn't mean much when these brutal tricks are standard fare. Oct 30 should be interesting.
Maybe trippin, but what has happened to suppress the actual harmlessness and genuine benefits of the bestbest drug in its class is actually astounding, almost beyond belief. There are actually some people in the world who might find that interesting and they're called cardiologists.
Those thoughts are rambling through the thoughts of many curious doctors being shown ANCHOR. Why is this rep able to show me this when they don't have an indication approval? This isn't right. "You can call the company if you have questions". When doctors call the company they can find out what else there is to tell.
Shortyfishfry, more sane words could not be spoken. The trend is in tact. My take. Docs for the first time are hearing and seeing strong evidence that not only is Vascepa potentially a life saver, it's also safer than anything else. They get to see JELIS for Petes sake. That just started to happen. This coincides exactly with the largest one week jump that was not a week after a holiday. Heck, it looks like Amarin slowed down their sales visits the two weeks prior for training, so the jump might be even more impressive. AND the effects are geometric since the docs that switched to Vascepa will continue to do so, but a new slurry of docs will be added each week to add to the count. I hope I'm right.
Yes, would be good to have some outsized increases. They definitely started 1st A two weeks ago and scripts hopped. Now it's a holiday shortened week to mask a newfound raging current of increases. Next Friday should tell the real story. Sorry Swalchie, thinking 20,000 by week ending 9/25 is going to happen although nobody else seems to understand math.
Hey Swalchie, your prediction that it's all about R-It is coming true. We do know approximately when events hit interim and that's a three or four month window, Jan-Apr 2016. At least based on company statements and pure math. Hope your investing and health isis all going well.
Indeed, yet they have raised enough cash to be okay through 2016. In between we have two events that could raise the price dramatically. It's quite normal for the stock price to aggregate scenarios but Amarin is tending towards persistent pessism. The other side of that is unbridled enthusiasm which lurks just underneath this biotechs heart.