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Please add yourself to my thanks to iwfal for the clarification.
Context is everything.
Thanks for the clarification.
Beats me, but the FDA language I quoted is unequivocal.
Does this affect your view?
FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved
It seems to take the unequivocal view that approval will be delayed as long as there are any open patent issues, irrespective of the expiry of the 30 month exclusivity period.
LOL, the only thing I won yesterday was deciding not to add to my MNTA just yet.
Was ARIA the subject of an index rebalancing today? That might explain the volume.
IMUC over 6X average volume. Price change was in the order of 2%.
21 of 22, was stupid on #2.
The minority held that the pharmacist is the salesman? Weird.
Not necessarily - it delays the inevitable - meaning the acceptance that Greece does not belong in the Eurozone.
To which the riposte might be that if so, California does not belong in the $zone. I wonder how California Eurobonds would be priced today.
I did, but Canossa'ed yesterday.
NYT Personalized medicine, in a way.
Michael Zamora/Corpus Christi Caller-Times, via Associated Press
Could exercise actually be bad for some healthy people? A well-known group of researchers, including one who helped write the scientific paper justifying national guidelines that promote exercise for all, say the answer may be a qualified yes.
By analyzing data from six rigorous exercise studies involving 1,687 people, the group found that about 10 percent actually got worse on at least one measure related to heart disease: blood pressure and levels of insulin, HDL cholesterol or triglycerides. About 7 percent got worse on at least two measures. And the researchers say they do not know why.
“It is bizarre,” said Claude Bouchard, lead author of the paper, published on Wednesday in PLoS One, and a professor of genetics and nutrition at the Pennington Biomedical Research Center, part of the Louisian State University system.
Dr. Michael Lauer, director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, the lead federal research institute on heart disease and strokes, was among the experts not involved in the provocative study who applauded it. “It is an interesting and well done study,” he said.
Others worried about its consequences.
“There are a lot of people out there looking for any excuse not to exercise,” said William Haskell, emeritus professor of medicine at the Stanford Prevention Research Center. “This might be an excuse for them to say, ‘Oh, I must be one of those ten percent.’ “
But counterbalancing the ten percent who got worse were about the same proportion who had an exaggeratedly good response on at least one measure. Others had responses ranging from little or no change up to big changes, seen in about 10 percent, where risk factor measurements improved anywhere from 20 to 50 percent
“That should make folks happy,” said Dr. William E. Kraus, a co-author of the study who is professor of medicine and director of clinical research at Duke. He was a member of the committee providing the scientific overview for the Department of Health and Human Services’ national exercise guidelines, which advise moderate exercise for at least 150 minutes a week.
The problem with studies of exercise and health, researchers point out, is that while they often measure things like blood pressure or insulin levels, they do not follow people long enough to see if improvements translate into fewer heart attacks or a longer life. Instead researchers infer that such changes lead to better outcomes — something that may or may not be true.
Some critics have noted that there is no indication that those who had what Dr. Bouchard is calling an adverse response to exercise actually had more heart attacks or other bad health outcomes. But Dr. Bouchard said if people wanted to use changes in risk factors to infer that those who exercise are healthier, they could not then turn around and say there is no evidence of harm when the risk factor changes go in the wrong direction.
“You can’t have it both ways,” Dr. Bouchard said.<snip>
CHOICE AT THE PUMP FOR EVERY AMERICAN
I'd like straight gas, please.
Not chiming in, but it's remarkable how the assumption that supplements are like chicken soup - they can't hurt - is taking serious hits. Megadoses of just about anything are suspect.
Admittedly I o.d. on Vitamin D, but that's about it in the vitamin family. I also take garlic and cayenne (a lot) and curcumin (a little).
The 98 number was a best case speculation. The best case conditions did not occur.
As a result, I think a 4 year target for 1 billion in sales is more appropriate, and not absurdly bullish in any way.
What P/S ratio might be appropriate then?
This is being well received, as indeed it might
MOLINE, Ill. (AP) -- Deere is posting a 17 percent spike in profits for the second quarter is raising its outlook for the year, with farm receipts expected to hit historic heights.
The company beat Wall Street expectations on net income and revenue, posting a profit of $1.06 billion, or $2.61 per share, up from $904 million, or $2.12 per share, in the same quarter last year.
Revenue jumped 12 percent to $10 billion, from $8.9 billion.
Deere & Co., based in Moline, Ill., said Wednesday that it expects equipment sales to increase about 15 percent in 2012 and is raising its full-year profit prediction to about $3.35 billion. Deere previously predicted profits of $2.75 billion.
Shares are edging higher in premarket trading.
Actually, it sounds plausible!
I missed out on increasing my ARIA position, unfortunately, and am actually down to a core position. I recognize the importance of the 113 news but am generally cautious against the background of an uncertain market. Which means I'm on the side of raising cash rather than deploying it. From which it follows that I may be missing the boat.
DVAX is simply too strange to venture a guess as to what might be going on. They certainly are not signaling a buyout. Why accept such a haircut (roughly 15%) unless they are cash constrained, which they don't seem to be. Bizarre.
DVAX seems to think Heplisav is approvable, but this may be whistling past the graveyard.
BERKELEY, CA--(Marketwire -05/08/12)- Dynavax Technologies Corporation (DVAX) announced today, that following the recent submission of the U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA), it intends to begin developing a commercial operation capable of independently launching HEPLISAV™ in the U.S. The Company believes that being able to bring HEPLISAV to the market successfully will ultimately help maximize long-term value for its shareholders.
DVAX
I don't recall ever seeing a post offering fiasco to match this one. The market saw value above 5$ at the beginning of the week - what the hell happened to drive it down to 3.85? The CEO's departure? Why did they feel constrained to accept such a huge discount from the pre-offering market?
I had a nice little gain that has gone poof. And re-poof.
excerpt from NYT re biophosphanates
In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations.
The F.D.A. review, published in The New England Journal of Medicine online Wednesday, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which have been sold under such brand names as Fosamax, Boniva, Actonel and Reclast. The concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to “rare but serious adverse events,” including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jawbone.
Although the concerns about the long-term safety of bone drugs are not new, the F.D.A. performed its own systematic review of the effectiveness of bisphosphonates after years of use. The agency’s analysis, which found little if any benefit from the drugs after three to five years of use, may prompt doctors around the country to rethink how they prescribe them.
The F.D.A. review analyzes only long-term use and does not address whether a woman should be prescribed a bone drug in the first place to reduce her fracture risk. Because serious complications are so rare, most doctors believe that for women with documented osteoporosis who are at very high risk for spinal fractures, the benefits of the drugs far outweigh the risks. However, some women with moderate bone density and no other risk factors continue to take the drugs for years even though they are unlikely to gain any benefits.
“I think a lot of people are going to come off this drug,” said Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute.<snip>
The jury deliberating over Oracle Corp.'s ORCL -1.63% claims Google Inc. GOOG +2.07% infringed copyrights protecting Oracle's Java technology reached a mixed decision Monday that would leave Google liable for only for a relatively minimal amount damages.
The jury decided Google did make use of Oracle's Java interfaces, but was unable to reach a decision on whether that was protected under the so-called fair-use doctrine.
Merrill Lynch
Warner Chilcott (WCRX) has been added to the US 1 list today. Today's closing price will be the addition price for the stock.
Every little bit helps.
Calend-air girls: Now Ryanair asks staff to stay slim in hope of reducing weight of plane with incentive of appearing in staff calendar
Ryanair spokesperson Stephen McNamara claimed that every little helped in reducing the weight of aircraft, including a svelte staff
Saving fuel on flights is a weighty issue for airlines with rising oil prices eating into their profits.
In a somewhat controversial move, Ryanair spokesperson Stephen McNamara said Ryanair staff had been asked to consider their own body weight in a bid to reduce aircraft weight and avoid hefty industry costs.
The budget airline has also announced it is to reduce the size of its in-flight magazine, serve less ice in drinks and encourage its staff not to pile on the pounds.
'We cut costs wherever possible, and the changes will represent a significant reduction in weight,' Mr McNamara told the Daily Telegraph.
'We also considered removing armrests, but decided against it. We even encourage staff to watch their weight – with the motivation of appearing in the annual Ryanair calendar.'
The latest policy will see the airline's in-flight magazine 'Let's Go with Ryanair' being reduced from an A4 to an A5 format and it will also double as a menu, which could save thousands of pounds in fuel thanks to the reduced amount of paper used.
Read more: http://www.dailymail.co.uk/news/article-2125446/Ryanair-reduces-flight-weight-smaller-magazines-ice-cubes-slim-staff.html#ixzz1tQfEBJoI
It could have been a great country.
It was, in 1912. The impressive turn of the last century buildings in Buenos Aires are a legacy of that era.
Their lawyers got cold feet, I'd surmise.
This? Time stamp is 2:15
WASHINGTON, April 27 (Reuters) - U.S. health regulators on Friday approved Vivus Inc.'s avanafil treatment for erectile dysfunction, giving the small company, which has struggled to bring a weight loss drug to market, a potentially lucrative commercial product.
Isn't that article some 3 years old?
The confounder in these national comparisons is that so much Jpn gov't debt is owed domestically.
Here's a demographic headwind to ponder.
Japan’s overall population fell by a record quarter-million to 127.8 million last year, hurt by falling birthrates and people departing for other countries. By 2060, the Japanese population is expected to fall by an additional one-third, to as few as 87 million —and 40 percent of those remaining will be over 65 years old.
And what is the likelihood of this ever being approved in the U.S. and being commercially viable, especially in light of all of the recent advances in prostate cancer drugs?
Beats me.
I know of one urologist who had an apparently thriving business taking patients to the Bahamas at exorbitant cost to carry out the procedure there. He was successful enough that he moved his practice from South Carolina to NYC.
He once threw me out of his office when I told him after a 3/4 hour wait that my time was as valuable as his - I thought he was going to call the cops, he was so furious. That's how I know that he is a famous and successful surgeon.
If the procedure is as successful as claimed and can be done on an outpatient basis, it seems to me it could be commercially viable. Not many current procedures promise cures on an outpatient basis - but I have no personal experience of HIFU. I decided against it mainly because of the cost, but also the faint smell of a cult.
HIFU is well recognized as a valid treatment for prostate Cancer, even though not approved in the U.S.
There are a lot of warring factions in prostate cancer treatment. Any M.D. wedded to radiation (in various forms, prostatectomy (including Davinci) cryotherapy, proton therapy etc etc will be happy to provide the bear case. They are a mutually hostile bunch.
That said, HIFU sounds attractive, in the hands of a specialist who is well practiced and aims right.
Where does this iteration of HIFU stand in the FDA approval process?
That's a lot of money from Post-it stickers and Scotch tape.
Tue Apr 24, 2012 8:01am EDT
(Reuters) - 3M Co reported a 4 percent rise in quarterly profit on Tuesday helped by growth in the transportation business and the Americas region.
The Minneapolis company also provided a modest increase to its full-year profit outlook.
The maker of Post-It notes, Scotch tape and components for consumer electronics reported net earnings of $1.12 billion, or $1.59 per share, compared with $1.08 billion, or $1.49 per share, a year earlier.
You find the GDT in unexpected places.
"Demographic" might not always be the right category for a country like China though. The Economist has a piece on the cumulative demographic effect of the one-child policy in China. Almost putting it on a par with Japan.
WSJ
VISALIA, Calif.—California's agricultural Central Valley has thrived for decades on Americans' seemingly endless appetites. Now, with U.S. market growth slowing, farmers are going after a different group of consumers: middle-class Chinese attracted to Western fare like milk and almonds.
Consider Dave Bush, operating chief of California Dairies Inc. Mr. Bush recently discovered that the dairy cooperative, the nation's second-largest, wasn't exporting very much to China, whose population is now the world's biggest consumer of milk powder. So he invested $35 million in machines here that process milk into powder to meet Chinese and other Asian requirements.
"We're in an evolution," Mr. Bush said. "No question."
The shifting global economy is forcing more U.S. farmers to turn to markets they once treated as an afterthought and reshaping the relationship between rural America and the rest of the world. Milk powder from California Dairies now ends up in ice cream, flavored dairy drinks and infant formula sold by China's biggest dairy company, Inner Mongolia Yili Industrial Group .
Soybeans, used largely for feeding livestock, remain the largest American agricultural export to China. Big Midwestern growers of commodities such as soybeans and corn have looked to the Chinese market for several years. But the interest in food meant for consumers themselves is more recent.
Chinese demand for American food is linked to shifting tastes, limited domestic supply and concerns about the quality of domestic products. But when it comes to milk, American producers have lagged behind their rivals in New Zealand. On a recent grocery trip, 23-year-old Beijing finance worker Huang Xin said she would buy American milk if she could find any in her usual markets. Ms. Huang looks for New Zealand labels or Chinese brands that haven't been caught up in safety scandals.
"I just want something that tastes good and that isn't going to hurt me," Ms. Huang said.
New Zealand, the top milk exporter in the world, has benefited for years from an early investment in exports, and it sold about 379,700 tons of milk powder to China in 2011, up 10% from the previous year, according to the Global Trade Information Services. By comparison, the U.S. exported 14,900 tons last year, down 4% from 2010, according to the U.S. Department of Agriculture.
Driving through his sprawling dairy farm outside Visalia, lifelong dairyman John Moons said he is still reeling from the recent recession and sees a glimmer of hope in China's interest in milk powder—a product that had been low on American dairies' priority lists for years because it wasn't coveted in the U.S.
"All of a sudden, milk powder has become this valuable commodity," said Mr. Moons, whose farm belongs to the California Dairies cooperative. "It's exciting to know that demand's going to be there."
With many of the newly popular exports to China grown close to the important Pacific Ocean ports in California, the milk industry isn't alone. In 2010, California exported $1.4 billion worth of agricultural goods to China and Hong Kong, up 86% from 2008, according to the University of California Agricultural Issues Center. By comparison, U.S.-wide exports to China of $15 billion in the year ended September 2010 were up only 34% from 2008, according to U.S. Census Bureau trade data.
In December, California's entry in this year's Miss America pageant traveled across China to promote pistachios with the American Pistachio Growers. The Almond Board of California is sponsoring student-recipe contests in China. A trade group for Napa Valley wineries last year started plastering billboards in Shanghai and Beijing with images like the Golden Gate Bridge and a tow-haired surfer alongside the tagline, "Discover California wines."
California Dairies buys raw milk from cooperative members like Mr. Moons, who together own the business, and processes it into products like fluid milk, butter and milk powder. In recent years, the dairy noticed that China's inability to meet domestic demand for milk was boosting the demand for foreign milk powder that was then processed in China into dairy products.
China consumed an average of 1,338 kilotons of milk powder annually from 2008 to 2010, compared with 528 kilotons consumed each year in the U.S., according to the Organization for Economic Cooperation and Development and the Food and Agriculture Organization of the United Nations.
The challenge for Mr. Bush of California Dairies was that U.S. dairies have long produced the wrong kind of milk powder for China and other Asian countries. China imports mostly long-lasting milk powder to mix with water and other ingredients and make products such as fluid milk that can sit on a grocery shelf without spoiling.
U.S. milk producers, on the other hand, have produced a variety that can't sit very long at room temperature after being turned into those dairy products.
The company opened a new plant in 2009 with machinery capable of making longer-lasting powder, and it plans another facility with even more equipment within five years. The goal: getting China sales up to one-third of the company's exports, from about 5% today.
—Laurie Burkitt in Beijing contributed to this article.
Write to Vauhini Vara at vauhini.vara@wsj.com
Sounds like the Plunge Protection Team in a new role tasked with a Dendreon plunge?
Peronism is ingrained in the genes of Argentinian politicians of the left.
yep