Mineral oil was used in the Lovaza trial and similar increases in ldl-c occurred. The FDA knew this and approved the Anchor set up. Patients with higher triglycerides normally have low ldl-c so increases in those numbers hardly matter. Mineral oil is considered inert and has been since the 40's. There is no there there. It was a convenient distraction to slow down Vascepa's eventual market dominance.
Hey Swalchie, hope all is okay for you. You've been absolutely right every step of the way, it all comes down to R-It. Amazing. Biotechs usually are a bit excitable, but not this stock.
To keep what Amarin said about Interim expectancy valid, the number of events required to hit 967 before June 30th should be far less than the total would be on average at mid-year. If the number of events each month on average was 35, (it's in that range),, the number shouldn't be 210 away or 757 to start on Jan 1. In a shorter time frame, variations can swing that number wildly. What if the average for the next 6 months is 30? Than we're into July or maybe even August and that's the second quarter and that's a no no because Amarin would have been misleading investors. No, they needed to know the number was way less than 210 or whatever the total expectation for those months was predicted to be. If 35/month is expected, than a good safe zone would be 25 per month. That's 150 events. That's a good margin for error. But they could just as well have felt confident saying the "first half of the year" if the number was 75 since a big slow down could take them just past March, (otherwise they might have just said first quarter). The flip side is a rapid event occurrence. So, if we start with 75 events needed, at 892, to reach 967, then a couple oversized event months, then we could be at interim tonight. Stranger things have happened. My prediction is April sometime, but it can happen any day between now and June 30th. We are in an unholy land.
The largest binary event in world history, (as far as market potential), is almost here. The stock price is incredible and illogical. This hire speaks volumes.
Swalchie, you've been right about this coming down to Reduce-It until now. Within the next 24 hours there will be a dramatic change.
Approximately 650 events occur between interim and final. That's all to occur before the end of 2017, which is confident guidance, and gives a clue to how close we might be to interim. We're very close. Now, consider the 967 events that need to happen to trigger interim analysis, how did we almost get here. By Feb 21st 2013, enrollment reached 50%. Last year at about this time, enrollment was around 7300. Of course, there is a dropout rate and enrollment times are all over the map, so the possibilities are endless; therefore the market is assuming a questionable or bad result similar to the fibrate and Nispan studies. What else is there for the critics to think? BUT...JELIS and CHERRY aren't imaginary studies. And REDUCE-IT picked the 50% profile from JELIS, most CVE benefit, and gave them more than double the dosage of those patients in JELIS. In the ANCHOR study double the dosage, 4 grams vs. 2 grams, (JELIS was 1.8 grams), did well more than double the improvement in the lipid numbers, especially the anti-inflammatory slate of numbers. By the way, actually reducing arterial plaque 15% in 6 months is a ridiculously good thing, as in CHERRY. I'll give the cynics their due, this stock is just being taken to the shed, but this is a pretty darn exciting time and scary.
They produce generic Lovaza and generic Tricor. They bought Allergan which contained Watson that made generic Vascepa and has sued the FDA for not appealing Judge Moss' ruling. They lose billions if Amarin succeeds. It's frustrating to hear new reports daily of people experiencing the miraculous healing properties of V, yet one companies billions are more important.
Akanz says comparing epa levels of a western population to a population of Japanese post-menopausal women creates uncertainty about meaningful effects of Reduce-It. The counter argument is that although a different chemistry exists in elderly Japanese women, they are human beings with remarkably healthy habits, so any help in reducing adverse heart events is also remarkable on top of statin, (21% total pop, 50% sub-group resembling R-It). It might not mean anything, but when the CHERRY study, just released, actually shows what is happening inside the arteries in a short period of time, (15% plaque reduction), it becomes rather obvious Vascepa might work. And that really should meet the original criteria needed for ANCHOR approval. Akanz also mentioned the statin involved in Reduce-It being much stronger. That is true and creates some doubt, but Vascepa seems to multiply beneficial effects and there is 2x the amount of epa in the study vs. JELIS. There's also the placebo argument that it might impact the lipid numbers.. BUT, in the end the only thing that really matters is what the Reduce-It results show. If there is a large decrease in CVD then the lipid numbers and the placebo effect won't mean as much, (they mean a lot but compared to death, I mean...). If epa acts the way we've seen in the many studies, the longer term assessment of the drug could also reveal the following: less joint pain, better cognition, better all cause mortality, fewer instances of cancer, fewer strokes, better mood and no serious side effects.
From the last earnings call JELIS wasn't mentioned, so I'm assuming that aspect of the first amendment allowed speech has not been implemented yet. Perhaps I'm wrong. ANCHOR data is nice and it will slowly change prescribing habits, yet the lipid numbers and anti-inflammatory properties are just numbers. Docs are looking to get their patients triglycerides under control along with many other considerations. Free ANCHOR speech isn't going to move the needle much. - - - December 17th is when the FDA and AMRN are supposed to come to some agreement on the first amendment case. Perhaps the JELIS study mention is part of that. No one seems to know exactly what they're agreeing to, if anything. ---- Finally, the little puppy that is Amarin, getting some notice as a sure short by many. For what it's worth, I have some words of advice. BE CAREFUL. Lipitor produced $125 million over 16 years and that was just one of the statins. Together at their peak, before generics,, statins sold over $25 billion per year because they reduced heart disease in patients with high cholesterol. If Reduce-It reduces CVD about the same as statins do; which is an additional decrease over and above what statins already do, then oh boy. The difference between all those statins; Lipitor, Crestors, Pravachol, Zocor, etc... is Vascepa will have no competition and it's reach is even broader when/if Reduce-It succeeds. This is just such a potential mega blockbuster. And they've done all the grunt work in years past to make this a well protected drug with ability to fight off almost any challenges. The amount of patents and their diversity creates a cocoon that'll last until 2030. Once a date arrives that mathematically dissects the intersection of success, (which might be 12/17), this stock could just rise every day for apparently no reason. Heck, I think it's almost here already. Those large purchases last week might be a warning shot. I don't know the magic date, somebody does.
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.