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We would anticipate filing (for approval by the U.S. Food and Drug Administration) in the first half of 2007.


James McDermott

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Based on information from the U.S. Food and Drug Administration, we had no reason to believe the amm...
JOAN MILES Also this year, we are beginning the process of seeking approval for a medicine in the U.S.. We are ...
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KRISH KRISHNAN In 1972, the Food and Drug Administration came through and said the building was too old to grind gr...
RONALD DAWSON The vast amount of waste and sheer stupidity in government - from the Pentagon to the Food and Drug ...
TOM COBURN I would certainly view the approval of this drug as a tremendous advance for women in this country.
SUSAN ALLEN The administration has moved quickly and placed the Food and Drug Administration in good hands ... D...
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BETTY MARTINI All of our labeling and all of our advertising is developed in compliance with [Food and Drug Admini...
DENISE FOY We expect something from the FTC this quarter. We said all along that we expect regulatory [approval...
ARCH CURRID We are not willing to give in on that. When we're finished the Food and Drug Administration will reg...
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HUGH KAUFMAN I would say that we would see an acceleration (in drug sales), especially in the second half of the ...
FRANZ HUMER We don't anticipate any sort of groundbreaking until well into 2007.
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DANIEL MELGAçO I believe that for the past twenty years there has been a creeping socialism spreading in the United...
DWIGHT DAVID EISENHOWER The government's Small Business Administration reports that small businesses represent 99% of al...
ELLEN TAUSCHER FDA approval should be the gold standard for comprehensive examination of drug safety. We shouldn't ...
CHUCK HADDEN Torture is illegal, both in the U.S. and abroad. So - and that is true for the Bush administration a...
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EVAN MASSEY In the first half, we forgot our game plan and (James) was just getting down the lane. In the second...
GILBERT ARENAS I would anticipate (a first order for the passenger version of the 747-8) next year,
ALAN MULALLY This Bible is for the government of the people, by the people and for the people.
JOHN WYCLIFFE It is better by noble boldness to run the risk of being subject to half the evils we anticipate than...
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JAMES SETTELMEYER It is better by noble boldness to run the risk of being subject to half of the evils we anticipate t...
HERODOTUS We missed 10 free throws in the first half alone and the first half of four 1-and-1s. We make those ...
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BILL KINSHERF Stay alert, stay alive.
MOTTO OF THE U.S. FIRST INFANTRY DIVISION IN VIETNAM Our ministry also supports orphanages in the U.S. and overseas, thousands of poor children in Latin ...
DAVID WILKERSON Canada may even regain G7 leadership by the end of this period if, as we expect, the pace of U.S. ac...
WARREN JESTIN But you also have to bear in mind that there still is an increased risk of stroke, dementia and bloo...
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GREG IP The message delivered by OMB is that performance and measurement will play critical roles in the rev...
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HEIDI KUNZ We are encouraged by the committee's recommendation for approval of what would be the only FDA-appro...
GEORGE QUESNELLE We're seeing that Denver has become a desirable place for Mexican drug-trafficking organizations as ...
JEFFREY SWEETIN Internet pharmacies return to consumers the choice promised by supporters of the 1938 Food, Drug and...
VIRGINIA POSTREL The people's government, made for the people, made by the people, and answerable to the people.
DANIEL WEBSTER While we are in the process of deploying U.S. Army troops for possible combat in Iraq, the Administr...
CHET EDWARDS We missed five lay-ups in the first half and shot three air balls. If we kept it closer in the first...
BILL MARTIN That's the first thing we're doing, filing for continuance.
JOE HOLLOMON We have worked very closely with all of our accounts to anticipate the level of demand for 'Harry Po...
BARBARA MARCUS We are pleased to have received approval of the transaction in all six states served by PacifiCorp. ...
GREG ABEL We hope the complex will be ready for occupancy by the fall of 2007.
RAY CARTER As bright examples of great qualities are but too uncommon among Christians, so are they singular an...
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ISMAIL ABDEL VETAH I think both in the U.S. and in Europe we are going to have a good first half until the trend in ear...
ANAIS FARAJ Now is the only time we have, and the only time that we have any control over.
RICHARD CARLSON I don't see the U.S. agreeing to anything and the next phase could be Europe filing against Japanese...
DAVID PRITCHARD The message delivered by OMB [the Office of Management and Budget] is that performance and measureme...
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THE PROPHET OF LIFE The coverage gap is like a cruel trick that the administration is playing on our nation's seniors, ....
FRANK LAUTENBERG Italy in the first years got food, for the first year or the first periods got food. Then we got raw...
GIANNI AGNELLI It's a good development and keeps them on track for the U.S. approval probably later this year.
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ANDREI MIRONOV Since all the bikes are donated [to BNB in the U.S.], we only charge the head of the business for th...
CARL KURZ Government of the people, by the people, for the people, shall not perish from the Earth.
ABRAHAM LINCOLN Not," Swift said firmly, "for all the tea in China."
"That expression has never made sense to m...
LISA KLEYPAS Sir,” James asked, “what are we going to do?”
“We’re going to look for water,” said...
DAVE BARRY These fines and the permanent injunction demonstrate that there is a strong system in place for ensu...
ANDREW ESCHENBACH These fines and the permanent injunction demonstrate that there is a strong system in place for ensu...
ANDREW C. VON ESCHENBACH the first dramatic signal from the U.S. administration that it is now ready to confront the pandemic...
STEPHEN LEWIS After not shooting well in the first half, we came back in the second half and got to within three a...
BOB SOULIERE The U.S. fiscal union has worked, in no small part, by enabling subsidies to the Mississippis withou...
AUSTAN GOOLSBEE Taking steps to reduce drug costs doesn't have to hamper drug development, as drug makers claim. Ada...
CURT FURBERG We expect a merger to go through an extended review process, particularly in light of the recent Dub...
INDER SINGH Chewing tiger nut is good exercise for the mouth, i love its nutty taste
SOTONYE ANGA Applause felt like approval, and it became a drug that soothed the pain, but only temporarily.
ANITA BAKER Italy in the first years got food, for the first year or the first periods got food. Then we got raw...
GIANNI AGNELLI There is definitely both a higher willingness to prescribe drugs and acceptance by families to have ...
ALISTAIR SINCLAIR A lot of things have changed since that task force made its recommendation. In the current climate, ...
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DAVID KANDEL During the 60's, drug use was in fashion in the U.S.
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BILL HARTWELL He's the first one to register for the 2007 elections.
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RICK RIORDAN In fiscal 2007, we anticipate gross capital expenditures of approximately $300 million. Planned expe...
AUSTIN LIGON We were the first to offer free electronic filing for everyone. We are making people an offer they c...
LANCE DUNN It's a big credibility issue for the drug war, more than anything, because there is a big contingent...
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LINDA MCDERMOTT I was never really a child actor. I was working sporadically in indie films in Pennsylvania, but I w...
CHARLIE MCDERMOTT I can be very lazy sometimes. Really lethargic!
CHARLIE MCDERMOTT We have been able to start a program for elementary school children with TUSD.
JUDY MCDERMOTT More than 350 million households all over the world watch this tournament.
JUDY MCDERMOTT The economic impact, obviously, is enormous for the area. The national television coverage is for al...
JUDY MCDERMOTT This is a very strong field, with winners of majors, and some of the top up-and-coming golfers.
JUDY MCDERMOTT If you want to see how far we have not come from the cave and the woods, from the lonely and dangero...
ALICE MCDERMOTT Everything Ashley Humphrey did was this guy's fault. Blame it on Mr. Humphrey.
JOSEPH MCDERMOTT It sounds like a long time and it is a long time, but it is not death.
JOSEPH MCDERMOTT He's not willing to pay for a study if the decision has already been made.
JOE MCDERMOTT Well, I think the cell phone calls, the letters that he wrote in jail, those were pretty damaging. A...
JOE MCDERMOTT So now everybody who paid higher taxes has to go back and recalculate 2002 taxes.
JOE MCDERMOTT This is a challenge for tax practitioners now, too.
JOE MCDERMOTT The state can't take that hit all at once.
JOE MCDERMOTT Heating relief or exemption is a very hot topic ... especially for people on fixed incomes.
JOE MCDERMOTT We did some of these cosmetic-type improvements so when people come to the grounds, not only do they...
JOE MCDERMOTT When a family comes in, they're getting more for their money.
JOE MCDERMOTT This is my 18th fair and I've never heard as much buzz about this one and the previous one.
JOE MCDERMOTT I don't think he's as bad of a guy as what the D.A.'s office wants to say.
SEAN MCDERMOTT This was, I thought, the language of shy men, men too much alone with their reading and their ideas ...
ALICE MCDERMOTT Richie Rich, Keoki, Amanda LaPore are really successful. They've joined the culture at large.
JAMES ST. JAMES I came to NYU to study experimental theater. Shortly thereafter, I was featured in a 'Newsweek&#...
JAMES ST. JAMES The true nature of evil is that it is so very casual.
JAMES ST. JAMES Why, oh why, must we always go through pigs to get our truffles?
JAMES ST. JAMES I would go to the all-night grocery store and pretend that I was at Studio 54 because it was the onl...
JAMES ST. JAMES We danced on the lip of the volcano, so to speak. We were young, too. And New York was still a big, ...
JAMES ST. JAMES I'll always be a party monster. I'll always love getting dressed up.
JAMES ST. JAMES As for my identity within the context of New York nightlife? I left in the '90s, so I'm not ...
JAMES ST. JAMES I was definitely the oddball freak show in school.
JAMES ST. JAMES When my trust fund ran out, I panicked. I have a lot of admiration for the kids who come to the big ...
JAMES ST. JAMES I think that when you are a teenager, it's the smartest you will ever be in your life. Teenagers...
JAMES ST. JAMES Watch out for the average--they're usually hiding something big.
JAMES ST. JAMES There are people who have too much space between their ears, and given the time, do nothing but free...
JAMES ST. JAMES War is devastating, and it leaves its scars for generations.
JAMES BLUNT National honor is the national property of the highest value.
JAMES MONROE