I deferred, what else can I say. Besides, they were working with the FDA on something so I guess they haven't been in a big hurry yet. Let's see what happens. Kind of a big market share gain though.
Swalchie doesn't think Amarin reps will be using the first amendment win anytime soon. I have to assume this is correct, otherwise tomorrow could be a shorts nightmare. A cardiologist seeing ANCHOR results for the first time would have to ask questions, such as, why are you allowed to show this to me? The sheer weight of a Judge overruling the FDA will raise profound questions, as will the ANCHOR data. Here's a typical reaction, "so, I've been prescribing something that might cause afib, yet this Vascepa has no such drawback and reduces trigs about the same and doesn't raise LDL-C and has highly positive effects on other lipids and inflammatory markers that Lovaza doesnt even compare to and it took a US Judge to be able to tell me that". Now, there are about 400 reps visiting 10 offices a day, getting to speak to about two doctors per day. That's about 4000 docs a week being exposed to this. The math is brutal because the docs, they aren't going to forget this new knowledge and the uniqueness of the way it's being delivered, (reps talking about something completely new without a new FDA approved indication), is going to be like a sledgehammer to the fibrates and Lovaza. It's coming, just not sure how soon, Swalchie is normally very accurate.
This is the Cherry study results. FDA's last chance to give Amarin a bigger market and insurance coverage to drop the 1st A case.
Clarity on the Alzheimer's. V eliminates the proteins found in Alzheimer's patients in healthy subjects thus eliminating the threat of Alzheimer's for anyone who hasn't already fallen prey. So everyone over 50 or with any family history of A should be taking V.
EPA cannot do everything, but it does plenty. Outside of the most recent CHERRY study backscatter showing a 20% reduction in arterial plaque over 6 months, it also helps in other ways. Note that all of these great ancillary benefits are not what Vascepa is being sold for but there are studies proving all of them have a strong possibility of being granted by taking V. There are many other benefit not listed below, but most of them relate to heart health and REDUCE-IT will be stopped around April 2016 to reveal the truth.
So, Vascepa eliminates the proteins found in the brains of Alzheimer’s patients and it slows the progression of the disease. It reduces cognitive impairment, improves mood, and alleviates bi-polar depression.
It slows aging.
It helps dry eye syndrome sufferers, perhaps better than current treatments, and it slows macular degeneration.
It reduces deadly heart attacks in hd patients by about 80%.
It helps reduce the chances of colon, breast, lung, skin, oral, prostate and liver cancers. It also reduces chance of stroke, reduces stroke severity and prevents complications after a stroke.
It helps diabetics improve their insulin sensitivity and blood sugar.
Ridiculously good results and demonstrably indicates what pure EPA does in the body. The FDA in their actions with ANCHOR have denied hundreds of thousands of patients less clogged arteries, and it's a certainty. But at least women have their sex pill now. Bar nights just got....what....no drinking? Oh darn.
I like the MAT9001 profile, it's amazing. Besides all the hurdles you point out, there are some other real concerns. How much DPA can be sourced is a concern. There are limits and it's more expensive, cutting down on margins. Also, the blood barrier is crossed easily by DPA, but what does that mean for blood thinning?
Definitely is a curious thing, that big a buy out of the blue. Over on ihub someone reported a Walmart having a big Vascepa week. A company that plans and wins two victories over the FDA in rapid fire succession isn't waiting to plan their strategy to take advantage, they did that over the last two years. This reminds me of the dips Apple always incurs after a big new launch. Once the first real numbers hit, which I think is next week, we should be hitting new 52 week highs.
Mindless market and a bevy of AMRN investors completely jaded by the weekly drumbeat of slow script gains, but nothing us the same. Prior to August 7th selling Vascepa consisted of saying hello, "we keep selling more", and a lot of doctors have prescribed it. The docs already know it doesn't raise LDL-C but they don't care. Patients with over 500 mg/dl trig's have low LDL-C and it doesn't matter. What does matter is Lovaza and fibrates reduce trigs faster in many cases. So selling to these docs was difficult in the extreme. After August 7th, talking about ANCHOR results differentiates Vascepa in these docs minds for the very first time. It might be instructive to remwber the markets reaction the first time ut feasted on ANCHOR results, the stock went ballistic, tripling in a matter of minutes. These reps visit 10 offices a day, that's 50 offices per week per rep. If each rep can convince just one doc to sell one more script each week, that would be a four fold increase in script growth. And that is totally too conservative. Good luck all, the ride is just beginning.
Good thoughts. It's such a difficult situation because a company like GSK could maybe explode sales of Vascepa to Lovaza numbers quickly and make a few billion over the next few years. Amarin's ramp will be much slower. If Reduce-It at interim proves effective and gets stopped, then we're talking about Lipitor type all time numbers possibly. So valuing any BO or merger is tuff biz, almost impossible. Throw in the still unsettled Watson case and the FDA/AMRN sit down arrangement and what insurance companies might do and Epanova and MAT9001 and the ISIS drug and, heck we need somebody in that position I guess.
The Japanese live 5 years longer than westerners. Much of that is attributed to their diet and lifestyle, they eat a lot of fish and they walk everywhere. The Japanese fish diet is the major cause for concern about REDUCE-IT since R-IT pulls a lot of it's hope from the Japanese JELIS study. The argument is: "Only because they have the AA/EPA ratio attained through constant life long intake of fish are they able to get advantage from the introduction of 1.8 grams of pure EPA daily".
My question. Since the Japanese live far longer than the western world, isn't that partially due to their diet, especially the fish oil. Wouldn't they be less likely to get benefit from additional EPA? They already achieved 5 years of life improvement. In a western population, they don't eat fish very often, so introducing pure EPA might have an exaggerated effect over what happened in JELIS. I'm saying, the argument that since Americans and Europeans don't have the beneficial level of fish oil in their system to get any advantage from smaller amounts of EPA might be completely wrong. Giving then 1.8 grams instead of 4 might help them a lot, it's the inflammation reduction that's the key and Vascepa always does that. Helping a body that's starving with a flood of EPA seems easier than to help a body that hardly notices the addition.
Almost the top weekly gain, outside of weeks after holidays, ever. Just happens to coincide with the FDA ruling. Call me stupid, and I know you will Swalchie, but I'd say that Amarin getting the right to mention everything they wanted to about ANCHOR will help substantially. The nearly $2 billion market cap AMRN reached after ANCHOR results was basically based on the situation that exists right now, except without Niaspan competing.
Largest gains seen in a long time in one week. This large increase appears to be due to one day, the date AF the ruling on a Friday. Imagine what a full week of 1st amendment might do?
All these stories about the first amendment win miss the fact Amarin was the only company that had safety to win the day. When Engelmayer asked the FDA if they could show a patient taking Vascepa that had a serious side effect, they said no. That exchange changed his view and you can tell from the transcripts it was the turning point. Gemfibrozil, Tricor, Lovaza, Niaspan. .ask the FDA the same and they can name thousands of cases. Plain and simple, the FDA should have granted ANCHOR; because a medicine that is completely safe only exists in this one drug, and it has not been proven ineffective, in fact, the opposite has been strongly suggested by JELIS. So, giving ANCHOR eliminates the serious side effect possibilities and gives patients real hope. It was safety that killed the FDA argument.
Lost nearly everything. Always had ANCHOR approval in our pockets. My predictions were completely wrong, doctors didnt budge much with just the Marine indication, although they were more than happy to continue with Lovaza and Niaspan off label. Negative fish oil articles poured out at inopportune times and NCE just was always right around the corner. Didn't realize how much Amarin's hands were tied, but just knew ANCHOR was the winning hand, and it would have been. They basically have mini Anchor now and that's pretty good.
Amarin cannot mention JELIS or much at all. BUT what they can mention is exactly what doctors need to see to change prescribing habits, specifically away from Lovaza . It won't help other drugs at all, the language and disclaimers all relate to Vascepa only. The ruling opens the possibility for wider off label truthful speech, but not yet. Amarin gets all the benefit front . The Judges ruling was remarkable, I laughed out loud reading because it so perfectly ties nearly all the FDA arguments against them.
Okay you may be right. Seems to me Amarin just beat the FDA twice and they've been practicing some kind of Anchor wording for years and the court just gave them almost everything they asked to tell. They know this playbook by heart and I'm sure Mr. Abrams helped stir the troops.