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Endocrinologic and Metabolic Drugs Advisory Committee Roster;
http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm096416.htm
Chairperson
Vacant (Dr. JL... paging Dr JL?)
Committee Member
Vera A. Bittner, M.D., M.S.P.H.
Expertise: Cardiovascular Disease
Term: 04/25/2011 – 06/30/2014
Professor of Medicine
Section Head, Preventive Cardiology
University of Alabama at Birmingham
701 19th Street South, LHRB 310
Birmingham, Alabama 35294
See conference docs http://www.vindicomeded.com/cmelc/pdfs/TC1206CMEinfo.pdf
Omega-3 and other Novel Pharmacological Approaches in Managing Hyperlipidemia
(This educational activity is supported by an unrestricted grant from Reliant Pharmaceuticals.)
The epidemiology of hypertriglyceridemia and its impact on the healthcare system Vera Bittner, MD, MSPH,
is a Professor of Medicine and Section Head of Preventive Cardiology at the University of Alabama in Birmingham, Alabama.
Vera Bittner, MD, MSPH
Permissions;
1. Austin MA, Hokanson JE, Edwards KL. Hypertriglyceridemia as a cardiovascular risk factor.
Am J Cardiol. 1998;81:7B-12B.
2. Cui Y, Blumenthal RS, Flaws JA. Non-high-density
lipoprotein cholesterol level as a predictor of cardiovascular disease mortality. Arch Intern Med. 2001;161(11):1413-1419.
3. Bittner V, Hardison R, Kelsey SF. Non-high- density lipoprotein cholesterol levels predict five-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2002;106:2537-2542.
4. Hanak V, Munoz J, Teaque J, Stanley A Jr, Bittner V. Accuracy of the triglyceride to high-density lipoprotein cholesterol ratio for prediction of the low-density lipoprotein phenotype B. Am J Cardiol. 2004;94(2):219-222.
5. Gaziano JM, Hennekens CH, O’Donnell CJ, Breslow JL, Buring JE. Fasting triglycerides, high- density lipoprotein, and risk of myocardial infarction. Circulation. 1997;96(8):2520-2525.
Looks like the content presented here
http://www.medscape.org/viewarticle/550620
THE EPIDEMIOLOGY OF HYPERTRIGLYCERIDEMIA AND ITS IMPACT ON THE HEALTHCARE SYSTEM, PRESENTED BY VERA BITTNER, MD, MSPH
GoldmanSachs Increases Amarin Price Target to $9.00
(some skrewed up claims in this article, pasted verbatim WYSISYG)
(AMRN)
October 10th, 2013 - 0 comments - Filed Under - by Paige Hiatt
Investment analysts at Goldman Sachs Group Inc. hoisted their price target on shares of Amarin Co. plc (NASDAQ:AMRN) from $3.00 to $9.00 in a note issued to investors on Wednesday, American Banking News.com reports. The firm currently has a “neutral” rating on the stock. Goldman Sachs Group Inc.’s target price points to a potential upside of 42.86% from the company’s current price.
The analysts wrote, “Given that the upcoming advisory panel for AMRN’s Vascepa in the expanded ANCHOR indication on Oct. 16 is such an important catalyst (followed by the PDUFA on Dec. 20), we wanted to try and frame the potential outcomes and what we think it could mean to the stock, as well as provide an options strategy. We continue to believe there is a greater than 50% chance for a favorable outcome (we estimate ~60%). However, we view the overall risk/reward in the stock going into this event as being less favorable given reasonably high expectations. We remain Neutral.”
Amarin Co. plc (NASDAQ:AMRN) traded up 1.27% on Wednesday, hitting $6.38. The stock had a trading volume of 2,854,973 shares. Amarin Co. plc has a 52 week low of $5.12 and a 52 week high of $12.96. The stock’s 50-day moving average is $6.56 and its 200-day moving average is $6.4. The company’s market cap is $1.101 billion. Amarin Co. plc also was the target of unusually large options trading activity on Monday. Investors purchased 24,205 call options on the stock. This represents an increase of approximately 183% compared to the typical daily volume of 8,556 call options.
Amarin Co. plc (NASDAQ:AMRN) last announced its earnings results on Thursday, August 8th. The company reported ($0.26) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.38) by $0.12. The company had revenue of $5.50 million for the quarter. Analysts expect that Amarin Co. plc will post $-1.37 EPS for the current fiscal year.
A number of other analysts have also recently weighed in on AMRN. Analysts at JPMorgan Chase & Co. cut their price target on shares of Amarin Co. plc from $12.00 to $11.00 in a research note to investors on Friday, September 13th. They now have an “overweight” rating on the stock. Separately, analysts at Aegis reiterated a “buy” rating on shares of Amarin Co. plc in a research note to investors on Friday, September 13th. They now have a $30.00 price target on the stock. Finally, analysts at SunTrust initiated coverage on shares of Amarin Co. plc in a research note to investors on Wednesday, September 4th. They set a “buy” rating on the stock. Three equities research analysts have rated the stock with a hold rating and ten have given a buy rating to the company’s stock. Amarin Co. plc has a consensus rating of “Buy” and a consensus price target of $13.19.
Amarin Corporation plc (NASDAQ:AMRN) is a late-stage biopharmaceutical -company with expertise in lipid science focused on the treatment of cardiovascular disease.
street sources "Sources: BioMedTracker, TheStreet research, company reports."
The Battle of Midway continues over Amarin, and McClusky is in the air.
Good luck and God Speed.
10/16/13 Endocrinologic/Metabolic AdComm Meeting Announcement/webcast
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm365571.htm
Webcast Information
CDER plans to provide a free of charge, live webcast of the October 16, 2013, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2013 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee.
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm331504.htm)
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
BACKGROUND MATERIAL ( 2 days before AdCom) link on http://www.fda.gov/AdvisoryCommittees/Calendar/ucm365571.htm
Difficult throwing wet diapers over the recent price action.
Still think taking in cool logic beats blowing hot air , in the long runs.
and the rest of the day to yourself!
theres a scam here alright and its not fishy oil
Actually Wotton still owns/options/controls >1.5 million shares.
http://www.sec.gov/Archives/edgar/data/1016169/000118143113052324/xslF345X03/rrd391786.xml
http://openinsider.com/insider/Wotton-Paul-K/1300997
A couple % monthly unwind is not without reason or precedent but still those pesky trips to the well have cast a black cloud over ATRS
chica are you on SA? I'll send explanation
30K the wrong way is hard to watch
LOL have oil scams broken that many banks & minds ?
good read as usual.
RE
At least FDA screwed AMRN via OrangeBook a little early this month;
Other essential governmental activities pre-shut down;
WASHINGTON — Last week, the Department of Veterans Affairs bought $562,000 worth of artwork.
In a single day, the Agriculture Department spent $144,000 ontoner cartridges.
And, in a single purchase, the Coast Guard spent $178,000 on "Cubicle Furniture Rehab."
This string of big-ticket purchases was an unmistakable sign: It was "use it or lose it" season again in Washington.
All week, while Congress fought over next year's budget, federal workers were immersed in a separate frantic drama. They were trying to spend the rest of this year's budget before it is too late.
The reason for their haste is a system set up by Congress that, in many cases, requires agencies to spend all their allotted funds by Sept. 30.
If they don't, the money becomes worthless to them on Oct. 1. And — even worse — if they fail to spend the money now, Congress could dock their funding in future years. The incentive, as always, is to spend.
So they spent. It was the return of one of Washington's oldest bad habits: a blitz of expensive decisions, made by agencies with little incentive to save.
Private contractors — worried that sequestration would result in a smaller spending rush this year — brought in food to keep salespeople at their desks. Federal workers quizzed harried colleagues in the hallways, asking if they had spent it all yet.
"The way we budget [money] sets it up," said Sen. Tom Coburn, R-Okla. "Because instead of being praised for not spending all your money, you get cut for not spending all your money. And so we've got a perverse incentive in there." But, Coburn said, "nobody's talking about it but me and you."
Coburn said he had meant to mention it in his floor speech Wednesday. Then, when he got to the podium, he forgot.
"Use it or lose it" season is not marked on any official government calendars. But in Washington, it is as real as Christmas. And as lucrative.
And — it appears — about as permanent.
"We cannot expect our employees to believe that cost reduction efforts are serious if they see evidence of opportunistic spending in the last days of the Fiscal Year," President Lyndon B. Johnson wrote to underlings in May 1965. Even then, Johnson said an end-of-year binge was "an ancient practice — but that does not justify it or excuse it."
Today, government spending on contracts still spikes at the end of the fiscal year on Sept. 30.
In 2012, for instance, the government spent $45 billion on contracts in the last week of September, according to calculations by the fiscal-conservative group Public Notice. That was more than any other week — 9 percent of the year's contract spending money, spent in 2 percent of the year.
Much of it is spent smartly, on projects that had already gone through an extensive review.
But not all of it.
In 2010, for instance, the Internal Revenue Service had millions left over in an account to hire new personnel. The money would expire at year's end. Its solution was not a smart one.
The IRS spent the money on a lavish conference. Which included a "Star Trek" parody video starring IRS managers. Which was filmed on a "Star Trek" set that the IRS paid to build. (Sample dialogue: "We've received a distress call from the planet NoTax.")
"That is a major problem," acting IRS commissioner Daniel Werfel told Congress in June, explaining the role of "use it or lose it" in that debacle.
Other end-of-year mistakes are less spectacular — but they still cause problems. One recent study, for instance, found that information technology contracts signed at year's end often produced noticeably worse results than those signed in calmer times.
And late-September waste also weighs on its witnesses, federal workers. After President Barack Obama set up an online suggestion box for federal workers, many asked to get rid of the "use it or lose it" system. They suggested "rolling over" money for use in the next year. And they listed dumb things they had seen bought: three years' worth of staples. Portable generators that never got used. One said the National Guard bought so much ammunition that firing it all became a chore.
"When you get BORED from shooting MACHINE GUNS, there is a problem," an anonymous employee wrote.
"People want to do the right thing," said Dean Sinclair, a former State Department employee who is crusading to change the system. "It's not that the federal workforce is filled with bad people. The system sort of forces them to make bad decisions."
He suggests giving bonuses to managers who return leftover money to the Treasury at year's end. "It takes time and effort to waste money," Sinclair said. "Remember that."
- - -
Obama, like presidents before him, has exhorted agencies to plan better and avoid rushed decisions at year's end. But the White House says Congress is making that job harder.
Instead of approving full-year spending bills, the gridlocked legislature has been handing out money with "continuing resolutions" that last only a few weeks or months. So nobody's certain about their funding until later in the year. So the rush gets more rushed.
This year, finally, September came.
For contractors around Washington — battered by sequestration, budget cuts and the end of wars — this was the month they had been waiting for. "The flush," one analyst called it. A flood of money had been backed up inside agencies hampered by furloughs.
"Twenty-five percent of my business, right, will happen in this month. Twenty-five percent of my year," said Art Richer, the president of ImmixGroup, a contractor in Tysons Corner, Va. that helps software and computing companies seeking government business.
September in Washington used to be a time for selling face-to-face. Contractors visited the Pentagon. Small-town mayors queued up in the hallways at the Commerce Department, waiting to make a late-night pitch for grants.
But those buildings are off-limits now. So you sell from your desk. You sell with your voice. You sell with empathy, for the poor harried bureaucrat on the other end of the line. "Answer the phone smiling," Richer tells his people.
Of course the feds were stressed.
"We see them in the hallway, and you go, 'How much money are we going to lose?' " one Army officer said this week. That officer was involved in setting budgets for future years, and the meaning was clear: How much money are you not going to spend? Whatever that number was, it would be taken out of budgets for fiscal 2015, too.
This is not normal math. But this was not a normal time in Washington: You didn't save money to spend it later. You spent now, to spend later. "They know they're under the gun," the officer said, who spoke anonymously to talk about internal budgeting discussions.
- - -
On Monday, Immix began bringing its sales team three catered meals a day. If workers walked to Subway, they might lose a sale. On that day, Immix handled $16 million in business. A normal Monday is about $2 million.
Across the government, agencies were making big-ticket purchases — buying things with this year's money that could be used next year.
On Monday, VA paid $27,000 for an order of photographs showing sunsets, mountain peaks and country roads. They would go into a new center serving homeless veterans in Los Angeles; a spokeswoman described the art as "motivational and calming, professionally designed to enhance clinical operations."
On Tuesday, the USDA bought $127,000 worth of toner cartridges ("end of year," the order explained). VA spent another $220,000 on artwork for its hospitals.
On Wednesday, the Coast Guard paid $178,000 for cubicle furniture, replacing high-walled cubes with low-walled ones to improve the air flow in a large office area.
"Other higher-priority projects were not able to be executed, so they moved [money] to this lower-priority project" before the year's end, said Coast Guard spokesman Carlos Diaz. "The money was going to be spent anyway."
On Thursday, VA was buying art again. It spent $216,000 on artwork for a facility in Florida. In all, preliminary data showed that the agency made at least 18 percent of all its art purchases for the year in this one week. One-sixth of the buying in one-52nd of the year.
On Friday, the end was in sight.
"I feel good. Four days, right?" said Corey Forshee, a contracting officer at Joint Base Andrews in Maryland. Forshee was part of a team at Andrews that had done its best to beat the September rush.
The commander, trying to avoid a last-week rush, set his own deadline of Sept. 20. The pizza came early. The chaplain's office visited early ("use it or lose it" season is traditionally stressful enough to get the chaplain involved). The buying was nearly done.
Now, they had to wait for the last act of the last act: the "fall-out money."
This was cash that other parts of the Air Force had not been able to spend. It would be redistributed to this office at the last minute.
"We're waiting for money for that," Forshee said, going down a list of unfunded projects. A roof for the workout area. A bathroom renovation. "Just waiting for money," he repeated.
Across Washington, everybody had to wait.
"It's going to come down to Monday," said Richer, at ImmixGroup. On Friday, he said his sales had been about equal to last year's, despite worries about sequestration.
On Monday, Richer's people will sell until midnight. Then they will keep selling. "Money rolls across the continent," the feds say. Cash not spent in Washington might be spent by federal offices in California in the three hours before it is midnight there.
When it is midnight in California — 3 a.m. in Washington — they will keep on. There are federal offices in Hawaii, after all. And it will still be three hours until midnight there.
http://www.stripes.com/news/us/federal-agencies-continued-annual-spending-sprees-right-up-to-shutdown-1.244644
the last transaction on 8,Oct,Calls are up .05, or 10%
while the last 5,Oct,Put are only up .01.
In fact all the OCT Calls are up and most puts are down, some hard.
Do you happen to note the price of the 8 Call block at the time ?
Correct, David. Please go deeper on this topic.
yasuh yasuh! Guess that latest load of 210s are ripening sooner than expected.
I suppose the chart meant to BUY those stone drops ... but having stones always beats having a LOLly pop. Sure is nice to get some income for selling product , instead of selling off more of the company ! So many good choices out there, just gotta avoid the FRAUDS.
back when GEVO was building the GIFT tower, a peek inside ...
http://stmedia.startribune.com/images/3gevo0103.jpg
from article refers to buyback... hopefully that's dead, and they get converting another plant.
http://www.startribune.com/business/185417132.html
MARIETTA, Ga., Oct. 1, 2013 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has entered into a distribution agreement with Medtronic, Inc. and SpinalGraft Technologies, LLC ("SGT"), a wholly-owned subsidiary of Medtronic. Through the agreement, MiMedx will provide its PURION® processed allograft products to Medtronic to be marketed by SGT for spinal applications.
The MiMedx PURION® processed allograft products distributed to Medtronic will be private-labeled. SGT will promote, market and sell the private-labeled allografts to its customers and end-users through-out the United States.
MiMedx&Medtronic sign distribution deal for Purion products
MiMedx (MDXG) — which recently found itself at the center of a rather unpleasant HCT/P debate with the FDA — inks a distribution agreement with Medtronic (MDT) for the marketing of Purion allografts by an MDT subsidiary.
MDT's market presence will ensure broader access to the products, something MDXG is "very excited" about. (PR)
How is this going ? STILL ON ? Bye
I am seeing word purportedly from FDA that explains adcoms (and I presume pdufas), as paid in advance events, will run "in some fashion". F'urinestain is hounding AMRN adcom and put in a ?.
ok I am at the Happy Place RE the AMRN long & short of it. Words on SA.
Go get em
The Pharma Bureaucracy Index: Who’s Nimble, and Who’s Sloooowww?
http://www.xconomy.com/national/2013/09/30/pharma-bureaucracy-index-whos-nimble-whos-sloooowww/
Sears new article on eicosanoids..
http://www.drsears.com/ArticlePreview/tabid/399/itemid/66/Default.aspx
Hot off the presses...please get this out to everyone you know..
":>) JL
I missed this, reposting to sticky awhile
"tong war" LOL
jt / anyone send me an email. Happy to document the game. AtlasSnuggled@gmail monitored
Bio
you assume that opinion has anything whatsoever to do with AMRN, and not some other company. Look in your SA messages soon
adamfeuerstein;
more script numbers, big 3, unverified
Lovaza
9/20/2013 86696
9/13/2013 88787
Niaspan
9/20/2013 73879
9/13/2013 76246
Vascepa
9/20/2013 6019
9/13/2013 5830
Good call. But you get 1 hour on each Friday just after market close, called "Happy Hour" to PM anyone without joining. Or just swap throw away emails w/ e/o .
You get 1 hour on each Friday just after market close, called "Happy Hour" to PM anyone without joining. Or just swap throw away emails w/ e/o .
3648 open $6.5 weekly call contracts, 1138 sold today. Barely anything either side of that strike, 469 on $7 , tiny puts. The 6.5 calls ought to have been selling for at least 1/2 buck at noon, but closed at 0.04. Probably worth it to someone to kill them off.
Most all I have was rocking at 2 hours to close or so, most closed weak.
Steady volume in the AM cooled, a couple large volume events. 1/4 million brought about 1/2 hour up tick, 150 K set it back down ward, stopped my three 50K buys ( cover?), finally late 225K sell pushed it over the edge , oddly enough met by last hour trades spread out but about the same vol. Another 225K cover a dime down would be profitable.
hooey.Ray Kroc;a main reason Vascepa is standard-care for your burger and fries generation!
at the bottom of every post