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rich, what did lovaza use as placebo?
i cant find this quote in any of the docs, which one is it in?
amen kcsven. now all we need is for the bds to be clean so we can get some relief from the stress that amrn has caused us all. we are due.
ex
sorry, but its standard protocol to call an adcom for a first in class drug for a large new indication. nothing has been approved previously for Anchor indication. That is why they are calling the adcom. I think people get nervous as the open and shut nature of Anchor results really begs the question as to why the adcom is needed but the fact are its standard protocol for something this big and this new.
At the end of the day, fda wants the reduce it outcomes data. no one in the US has ever done such a study. they know that amrn needs anchor to pay for reduce it. that is the deal between the two - you hit anchor spa and we give you anchor, and in return you give us reduce it data.... thats the deal, period.
well said rich. combined with 20mm lovaza generic day plus govt shut down fear, there is no momentum in the name.
short term momentum could build post briefing docs if they seem clean, but i fear that the stock generally reacts badly to any type of hint of bad news. who knows, the shorts may just short it more once teh docs are out to scare people into thinking they are bad even if they arent...
Unfortuantely at this point, WS doesnt believe the AMRN story. Despite Marine, Anchor and patents, the only things they know is no NCE, GIA and uncertainty on outcomes.
While ironically GIA could mean a greater price longer term, and NCE is not nearly as important as the patent moat, these are huge negatives right now for the risk averse dumb long only mega funds.
HOpefully outcomes uncertainty fades, starting tomorrow morning. Just like big pharma, big long only mega funds would rather buy higher for a derisked story.
Good one Williams. Why Invokana hasnt been part of our discussion the last few months is a glaring oversight by the message board.
Tons of similarities to Vascepa except that Vascepa is safer!
and safety has been proven out by a year of Marine and ten years of Epadel....
In terms of safety, lets also not forget that in addition to Vascepa being on the market for almost a year, Epadel has been on the market since 1990 and has even been taken OTC in Japan. Thats a lot of safety data, I think.
Could you see Vascepa OTC with commercials on TV with Halle Berry, Drew Carey in a few years? Patents good till 2030!
also look at MDVN just ahead of interim look at Prevail trial in pre chemo...
the feds are gone and the bots are running wild out there.
get a few of these and many many more to do a series of commericals for vascepa on tv...
http://www.health.com/health/gallery/thumbnails/0,,20490828,00.html
Mine too.
A lot of bad luck here, no fault of the company along the way in terms of a patent examiner who early on was reluctant to issue new patents, then NCE delay, which combined caused GIA.
On top of that, this is a fish oil derived pill so its easy prey for non scientific people to criticize.
But when all is said and done, Anchor trial results were a walk off grand slam and everyone knows it. Somehow it seems that is taken off the table in discussions. On top of that, no matter what people say, the Marine launch, with a PUNY 275 person salesforce who will say nothing about off label use is steadily gaining market share.
As for Adcom, we have not heard one piece of hard fact information as to why a vote will be negative. Nothing. People can pick turdball of bs out of their ass but its just an opinion based on nothing concrete. What do we know for sure about this same Adcom is that they voted 12-1 to keep Avandia on the market for diabetics even though it can cause heart attacks. Yes, it was a 12-1 vote and it causes heart attacks.
http://www.forbes.com/sites/matthewherper/2013/06/06/what-the-fdas-avandia-decision-means-for-the-future/
Anchor was 70pct diabetic patients. Despite liver issues discussed on the board, the drug is placebo safe. It makes statins work better, it reduces trigs. JELIS is legit data. This is not niacin or fibrates or lovaza....
What this stock doesnt have going for it is an almost infinite number of shares, recently even made larger, and without a value-creating event in a long long time, basically since Marine approval. When Adcom is voted positive, for the first time in a very long time, there will be a real reason for big dumb risk averse funds to buy and for big dumb risk averse bp to revisit the story.
Net net, this has indeed been a wild ride with a lot of negative headlines along the way but no one has ever taken a shot at Anchor trial results because they cant. Get Tom Hanks on tv as your spokesman. Maybe he is too expensive, but there are a ton of middle aged celebrities with huge name recognition who have faded from the spotlight but everyone still knows. Get one of those guys as your spokesman and you got something going.
Like the Adcom will wait for outcomes data....
From the Tom Hanks Article:
"There's no question that the growth of diabetes both in the United States and around the world is at epidemic proportions," says Robert Ratner, the chief scientific and medical officer for the American Diabetes Association. He's an endocrinologist and diabetologist.
Almost 26 million children and adults (8.3% of the U.S. population) in the USA have diabetes, and about 79 million Americans have pre-diabetes and are at risk for developing the disease, government statistics show. One in three Americans may develop diabetes by 2050 if something isn't done to reverse the trend, government statistics suggest.
People who are obese, older or have a family history of diabetes, as well as African Americans, Mexican Americans and American Indians, are at increased risk of developing type 2 diabetes. Diabetes may lead to heart disease, stroke, kidney failure, foot and leg amputations, and blindness.
"The simple fact is our health care system and our economy are being overwhelmed by diabetes," Ratner says. "When we look at the number of individuals and the cost of their care, we see it's not a sustainable situation."
In 2012, the cost of diabetes totaled $245 billion in the U.S. alone, he says. "In 2007, the cost was $174 billion, so in only five years, there has been a 43% increase in the cost of caring for diabetes. The increased cost is driven by the epidemic numbers of people with the disease."
... and on and on...
Tom Hanks, a perfect Vascepa spokesman!!!
http://www.usatoday.com/story/news/nation/2013/10/08/type-2-diabetes-epidemic-tom-hanks/2945363/
still a lot of stock out there that needs to be absorbed on the way up...
additionally the v high trig group are likley "sicker" or more at risk of things like pancreatitis. the fact we have seen nothing on side effects from the marine population is a strong extra sign for safety of vascepa going into adcom. not even a fishy burp or a trot to the outhouse....
Mgt would not be stepping up to DTC dollars unless they knew Anchor is a done deal. Otherwise, the cash under a Marine only GIA is invaluable.
Columbus Day is not an NYSE holiday...
Bullish relative to mgt expectations on Anchor/ADcom, as it makes no sense to advertise like this just for Marine w a limited budget...
All of the statistical work on the Anchor data set was done a long time ago, even pre Marine approval. I think there is some chance for early approval if Adcom is positive. It may also be in FDA best interest to approve early if indeed NCE is somehow tied to approval, as they could finally get that box checked too...
At least somewhat. Good volume again today. Ill take it. This has been a tough ride, as we all know. I love you all but also have message board fatigue, and I dont even post that much...
This stock has dealt with a lot. Secondary, GIA, Lovaza generic, Italian study, prostate study , AF, shutdowns, NCE, and all the other things I can't remember. Ter is a ton of stick out there. The share price is grinding higher but let's be realistic. Good ADcom brings back people who like the story but have opted out for whatever reason. PDUFA brings back more. Hopefully by then weak hands are flushed out. Feels like the worst could be over with this drama queen stock. But we will see.
13th highest volume day of the year today. and btw, about 9 of the previous 12 higher volume days so far this year were accompanied by big downdrafts in the stock... technical trading slighty better, but resistance moving up is like a machine gun barrel melting in front of the endless hoards coming over the hill to attack.
Does anyone know what the experts said today at Cardiomet?
12:15pm – 1:45pm Lunch Symposium A
Triglyceride & Mixed Dyslipidemia Management: Expert Analysis of Cutting-Edge Data & Evidence-Based Recommendations for Reducing Residual CV Risk
Supported by an educational grant from Amarin Pharma, Inc. Christie Ballantyne, MD
Harold Bays, MD
Deepak L. Bhatt, MD, MPH
Sergio Fazio, MD, PhD
Terry Jacobson, MD
http://www.cardiometabolichealth.org/2013/agenda.asp
i love you all but i hope we are all long gone from this board by 2016....
just an infinite amount of stock for sale out there. whoever sold the calls knows that.
worrisome
maybe someone sold the puts and bought the calls?
Jesse
Any small biotech that GIAs will have their stock price go down.
Ajax - likley a combo of both your #1 and your #2. BP knew a potentially acceptable offer price would be high and that they would only pay such a price if it included NCE. No NCE and not worth making a bid...
agreed. we are here clamoring that the stock should be higher, but science aside, if you look at the numbers, you have a small drug co w huge cash burn who already had a $1B mkt cap, doing a GIA and numbers have to keep coming down while cash raises and other financings continue at a steady pace.
while we all believe in anchor, etc, one could make a decent case that it is not wildly undervalued unless you think anchor sells itself in six months...
All the rants aside, FUD has reached a crescendo, IMHO. No one said it would be easy. Long only money is risk averse and will wait till after the stock is bid up on good fundamental news. There is just too much stock out there for a good run up, esp after the 20mm share day on generic Lovaza. I dont think there is anything else going on.
We need volume to go up. Its not there.
That really killed any run up potential. 20mm shares that day.
The bear story is that Lovaza is almost all off label and that in in the mind of most docs, fish oil is a commodity. Thus little AMRN has a shitload of wood to chop to convince the US medical industry that Vascepa is truly different. People are skeptical of the cash burn it will take to convince docs unless of course Vascepa hitches a ride w BP.
We are all in love w Anchor results, SPAs, EPA/AA ratios, JELIS, etc. And we should be. WS knows Vascepa is good, but so does WS. Time will prove us right but might as well sit back and wait a bit.
I hope im wrong, but this is where we are. WS hates small company drug launches, period. They will all pile in when its obvious, but not before. Positive Adcom = $8.00, i hope.
gia, italian study, prostate study, lovaza generic, nce delay every month, af all the time, secondary at $5.75, govt shutdown. ive never seen anything like it. but after all that it is still an amazing drug and at some point, WS will get greedy.
Ajax
If someone did indeed know something that we dont know, I would think the stock would be drifting even lower.
Feels like there is still a seller post this govt noise. Im sure others have AMRN fatigue and easy enough for someone to throw in the towel...
im going nowhere near the atolls. i know a bit about coral reefs and the swell that hits them.
but thank you!
Thnx Akanz
Yes. There is no other direction but up from here. I wish I was about to set sail out the gate for hanalei bay and then on to the south seas for a couple of years. By then amrn will be fine. Maybe earlier but maybe not. I have faith but we all have message board fatigue at this point.
agreed. govt shut down or not, im glad its october now.
im ready for the flop, the turn, and the river. we are all tired of our two card hands.