The words from JT describing high prescribing physicians reaction to how they are responding to changing prescribing practices of Vascepa after seeing Jelis. Like they smoked a potent blunt. The last set of script numbers on the holiday shortened week tend to indicate that very thing is happening in spades. Friday's numbers this week are worth watching. Could be very high.
Hey Swalchie, I want to compliment you. It is, as you said, all about Reduce-It. Anyhow, I posted this without any knowledge of the PR coming.
With 20500 patient years in the books with RRR between 5.2-5.9 for placebo arm we're at 18-40% efficacy TODAY if 967 hasn't occurred yet. The FDA opened up the R-It study last year to check safety and found no serious side effects. So, pretty good chance R-It succeeds. The first amendment "capitulation" by AMRN doesn't help them much without a successful R-It, but with success that first amendment deal for two new indications to tout a year is mind boggling in added value. If you've ever seen The Big Short, investors in Amarin are suffering through what amounts to fraudulent activity before everything change, like the people who saw the fall of the housing market but kept getting burned by the ratings agencies.
If Vascepa shows efficacy for 150-500 trigs and gets that label, the 1st amendment win for 2 off label uses a year becomes a much bigger victory. Worth many billions.
For the next four years there is only one company, Amarin, that can promote off label and add new off label uses. Anyone ever think about dry eyes and hemodialysis patients? This ruling is unbelievable.
10 million patients would be about $28 billion per year in revenue or about $84 billion in cap at 3x sales or about a $400 share price. Just based on your assumption.
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.