FDA grants priority review to Roche’s breast cancer drug

(Reuters) – Roche, the world’s biggest maker of cancer drugs, said U.S. health regulators granted a priority review to its experimental breast cancer drug TDM-1, expediting the review process for the marketing application of the drug.

The U.S. Food and Drug Administration will announce its decision on the marketing approval by February 26, the Swiss drugmaker said.

The FDA grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.

Roche said its marketing application for the drug was accepted by European regulators.

TDM-1, or trastuzumab emtansine, is being developed with ImmunoGen, using ImmunoGen’s targeted antibody payload delivery technology.

Roche said in late-August that the drug significantly extended the lives of women with an aggressive type of breast cancer, compared with those receiving the standard drug cocktail.

(Reporting By Pallavi Ail in Bangalore; Editing by Maju Samuel)

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MF Global customers sue PricewaterhouseCoopers in amended lawsuit

NEW YORK (Reuters) – Former customers of MF Global Holdings Ltd‘s broker-dealer have added accounting firm PricewaterhouseCoopers LLP as a defendant in a lawsuit stemming from the collapse of the brokerage.

In an amended complaint filed in U.S. District Court in Manhattan on Monday, the customers of MF Global Inc accused PwC of failing to adequately audit MF Global’s internal controls over customer funds.

The complaint also repeated prior accusations against former officials at MF Global, including former Chief Executive Jon Corzine, who is accused of violating the Commodity Exchange Act, which restricts the use of customer funds.

Caroline Nolan, a spokeswoman for PwC, said it conducted its last audit of MF Global in March 2011 “in accordance with professional standards.” The audit at the time confirmed that MF Global had maintained its customer accounts in accordance with federal regulations, she said.

“We will defend this lawsuit vigorously,” Nolan said.

The lawsuit also named as a defendant CME Group Inc , the exchange that oversaw MF Global.

Neither a lawyer for Corzine nor spokesperson for CME Group immediately responded to requests for comment on the case.

An estimated $ 1.6 billion in customer funds went missing following MF Global’s collapse. MF Global filed for bankruptcy in October 2011.

Investigations by the U.S. Department of Justice and Commodity Futures Trading Commission are ongoing.

PwC had served as independent auditor of MF Global in 2010 and 2011, according to the complaint.

The lawsuit, which is seeking class action status, contends that PwC failed to examine MF Global’s controls over customer funds. This amounted to professional malpractice and a breach of the auditors duties to the company and customers, the lawsuit said.

“If PwC had properly executed its duties and evaluated and reported on ‘s control problems in March 2011, there would have been ample time for management to institute proper controls over customer funds,” the complaint said.

Lawyers for the plaintiffs are cooperating with James Giddens, the trustee for the liquidation of MF Global Inc. Under the deal, the plaintiffs’ lawyers say Giddens has assigned to them certain claims against MF Global’s directors and officers and PwC.

The case is DeAngelis et al v. Corzine et al, U.S. District Court, Southern District of New York, No. 11-07866.

(Reporting by Nate Raymond in New York; Editing by Dan Grebler)

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Methane warnings ignored before NZ mine disaster

WELLINGTON, New Zealand (AP) — A New Zealand coal mining company ignored 21 warnings that methane gas had accumulated to explosive levels before an underground explosion killed 29 workers two years ago, an investigation concluded.

The official report released Monday after 11 weeks of hearings on the disaster found broad safety problems in New Zealand workplaces and said the Pike River Coal company was exposing miners to unacceptable risks as it strove to meet financial targets.

“The company completely and utterly failed to protect its workers,” New Zealand Prime Minister John Key said Monday.

The country’s labor minister, Kate Wilkinson, resigned from her labor portfolio after the report’s release, saying she felt it was the honorable thing to do after the tragedy occurred on her watch. She plans to retain her remaining government responsibilities.

The Royal Commission report said New Zealand has a poor workplace safety record and its regulators failed to provide adequate oversight before the explosion.

At the time of the disaster, New Zealand had just two mine inspectors who were unable to keep up with their workload, the report said. Pike River was able to obtain a permit with no scrutiny of its initial health and safety plans and little ongoing scrutiny.

Key said he agrees with the report’s conclusion that there needs to be a philosophical shift in New Zealand from believing that companies are acting in the best interests of workers to a more proscriptive set of regulations that forces companies to do the right thing.

The commission’s report recommended a new agency be formed to focus solely on workplace health and safety problems. It also recommended a raft of measures to strengthen mine oversight.

Key said his government would consider the recommendations and hoped to implement most of them. He would not commit on forming a new agency. Workplace safety issues are currently one of the responsibilities of the Ministry of Business, Innovation and Employment.

In the seven weeks before the explosion, the Pike River company received 21 warnings from mine workers that methane gas had built up to explosive levels below ground and another 27 warnings of dangerous levels, the report said. The warnings continued right up until the morning of the deadly explosion.

The company used unconventional methods to get rid of methane, the report said. Some workers even rigged their machines to bypass the methane sensors after the machines kept automatically shutting down — something they were designed to do when methane levels got too high.

The company made a “major error” by placing a ventilation fan underground instead of on the surface, the report found. The fan failed after the first of several explosions, effectively shutting down the entire ventilation system. The company was also using water jets to cut the coal face, a highly specialized technique than can release large amounts of methane.

The report did not definitively conclude what sparked the explosion itself, although it noted that a pump was switched on immediately before the explosion, raising the possibility it was triggered by an electrical arc.

The now-bankrupt Pike River Coal company is not defending itself against charges it committed nine labor violations related to the disaster. Former chief executive Peter Whittall has pleaded not guilty to 12 violations and his lawyers say he is being scapegoated.

An Australian contractor was fined last month for three safety violations after its methane detector was found to be faulty at the time of the explosion.

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Staples to have Amazon lockers in U.S. stores: spokeswoman

NEW YORK (Reuters) – Staples Inc, the largest U.S. office supply retailer, has agreed to install “Amazon Lockers” in its U.S. stores, a Staples spokeswoman said on Monday.

The Amazon lockers at Staples will allow online shoppers to have packages sent to the office supply chain’s stores. Amazon already has such storage units at grocery, convenience and drug stores, many of which stay open around the clock.

Amazon.Com Inc, the world’s largest Internet retailer, is trying to let customers avoid having to wait for ordered packages due to a missed delivery.

With the service, Amazon sends customers an email with a pickup code, which is entered on a touchscreen to open the locker containing the package. Shoppers have three days from the delivery date to pick up the package.

The online giant pays a small fee to the owners of the stores that house its lockers.

Staples did not give any further details of the service.

(Reporting by Dhanya Skariachan; Editing by Dan Grebler)

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William Shatner – there’s an app for him

RALEIGH, North Carolina (Reuters) – Actor William Shatner is having a moment. A couple of years after CBS canceled his Twitter-inspired “$ #*! My Dad Says” TV comedy, Shatner is at the top of the tech world.

The former “Star Trek” captain, now 81, is featured in Blindlight Apps “Shatoetry”, which catapulted to the top of the entertainment app list on Apple iTunes last week on its first day of release.

The celebrity app allows users to choose from hundreds of words to arrange sentences, which Shatner will then recite in his trademark voice and style. There is also a mode that allows Shatner fans to collaborate on “Shatisms” and there are single-player challenges like creating Haiku and poetry.

Shatner, who is currently touring the country with his critically-acclaimed one-man Broadway show, “Shatner’s World,” took a few minutes to talk technology with Reuters.

Q: How would you like to expand this app moving forward? Perhaps adding music?

A: “Well, we have that in mind. Words to music. We have in mind holiday things. We have in mind events in your life, words so that you can use them as well. We will increase this if people love it and tell other people that they love it. When we get an audience we know that is worthwhile, we will add to it.”

Q: One audience you know you definitely have out there is “Star Trek” fans. Do you see any opportunities with special app add-ons for them?

A: “Well, yes. I don’t think we’ll leave opportunity unexplored, but I wanted to be very careful about how we introduce it so it is not something that is derogatory or stupid. I want to make sure that it’s used in the way it’s meant to be used, which is for your entertainment.”

Q: Do you see opportunities for other actors to work with you on this app?

A: “We hope that it becomes popular enough to interest people into doing some words.”

Q: So users would be able to mix your words with other actors’ words through this app?

A: “Yes. Exactly. Have them do keywords like ‘love.’ There are certain words that everybody wants to use like ‘love’ and ‘hate’ and words that you use somewhere in your conversation… Commonly used words that are positive, I think that would be a way of getting a well-known person to take a chance in interpreting that word several different ways and know that they won’t look foolish, or be made to look foolish.”

Q: How are you taking advantage of today’s technology to connect with fans?

A: “I’m using it in as many ways as feasible. I’m doing podcasts. I’m certainly doing everything else, Facebook, Twitter and all that kind of thing. I’m taking advantage of communicating with the people out there as much as possible, and this app is one of those ways.”

Q: What technology do you have?

A: “I have iPhone, an iPad and I will be getting an iPad Mini shortly.”

Q: How do you use those devices?

A: “I don’t play games. I read the newspapers. I’ve got a dictation sound-to-print app and since I don’t type very well, I find myself dictating to it and sending the notes on. It’s a truly creative tool with. Once you have a means of communicating – there’s so much wrong with the world and so many crises in the mix here that, if we can communicate faster and better, we may be able to fix them before the end of the world, as far as human beings are concerned.”

Q: How’s the tour going for your show “Shatner’s World”?

A: “I’m going to be in Connecticut and New Jersey this week. I’m playing about four different places that are just opening up now. My heart goes out to the nightmare that these people are in. I feel a little awkward in talking about providing a laugh or two, but on the other hand some people may need that, and that’s what I’ll be doing….I will be with my heart on my sleeve trying to entertain people who have had a great deal of hardship in the last week.”

Q: A lot of my friends in New York and New Jersey are still without power after Hurricane Sandy.

A: “I know, and hopefully by the time I get there, there will be power. And hopefully by that time, they’ll be of a mind to be able to want to be entertained.”

(Reporting by John Gaudiosi, editing by Jill Serjeant and Marguerita Choy)

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When it comes to colon cancer checks, options exist

NEW YORK (Reuters Health) – For people who have had a negative colonoscopy, less-invasive screening options may work just fine for follow-up cancer tests, a new analysis suggests.

“No one screening test is right for everyone,” lead researcher Amy Knudsen, from the Institute for Technology Assessment at Massachusetts General Hospital in Boston, told Reuters Health in an email.

The findings, which are based on a mathematical model, showed life expectancy varied by only a few days between people who continued getting colonoscopies every ten years and those who chose annual fecal blood tests and other less-invasive alternatives.

“The best test for you depends on your risk, your preferences, and which screening approach you are willing and able to adhere to, since no screening is effective unless it’s done,” she added.

“Patients should talk with their doctors to decide which test is best for them.”

Knudsen’s team fed colon cancer screening and survival data into a National Cancer Institute (NCI) model, starting with hypothetical study participants that had a negative colonoscopy at age 50.

The researchers found that with no further screening, 31 out of every 1,000 people would be diagnosed with colon cancer during their lives and 12 would die from it. For people who continued having colonoscopies every ten years, that would fall to eight colon cancer diagnoses and two deaths per 1,000 people.

With annual fecal tests starting at age 60, Knudsen and her colleagues calculated that 11 to 13 out of every 1,000 people would get colon cancer, and three or four would die.

And with the last screening method, known as computed tomographic colonography, or CTC, nine people would be diagnosed with cancer and three would die if the tests were done every five years. Like colonoscopy, CTC requires bowel preparation, but otherwise is not as invasive.

The less-invasive screening methods would each cause about half as many complications as colonoscopy – affecting one percent of patients versus two percent, according to findings published Monday in the Annals of Internal Medicine. Those complications include bleeding and colon perforations.

“All of these methods will work if your ultimate goal is to reduce deaths from colon cancer,” said gastroenterologist Dr. David Weinberg from Fox Chase Cancer Center in Philadelphia, who wrote an editorial accompanying the study.

PAYING A LOT MORE

According to the NCI, about 143,000 people are expected to be diagnosed with colon or rectal cancer in 2012, and close to 52,000 will die of the disease.

Weinberg said one of the advantages of colonoscopy is that it finds pre-cancerous polyps that can be removed before they turn into cancer.

Fecal blood tests, on the other hand, typically catch very early cancers, so more patients screened that way will get cancer and need treatment, although they’ll have a good prognosis.

Colonoscopy is also more expensive than other options, at a bit over $ 1,000 a pop – and getting the procedure is typically not the most pleasant experience. A fecal test costs $ 20 to $ 50, and CTC about $ 500.

“If everybody gets a colonoscopy, you will have many fewer people who ever develop colon cancer, but you’re going to pay a lot more money to get that effect,” Weinberg told Reuters Health.

“What people and populations have to decide is, how do you want to spend your money?”

Although it’s a limitation that the results are based on a mathematical model and not on screening and outcomes for real people, Weinberg said a comparable human study will likely never be done because of the time and money required.

Based on the available evidence, the United States Preventive Services Task Force, a government-backed panel, recommends screening for colon cancer using colonoscopy, sigmoidoscopy or fecal occult blood testing between age 50 and 75.

Although both colonoscopy and fecal blood tests are available most places in the U.S., other tests including CTC may be harder to find, or not reimbursed by insurance, according to Weinberg.

SOURCE: http://bitly.com/MnBiCA Annals of Internal Medicine, online November 5, 2012.

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About That Gold Stored in Flood-Prone Lower Manhattan

As New York City continues to dry out in the aftermath of Hurricane Sandy, the financial world is reconsidering just how smart it is to place critical pieces of infrastructure in flood-prone areas. Citigroup’s (C) waterlogged building at 111 Wall St. will be unusable for several weeks, and two critical Verizon Communications (VZ) facilities suffered extensive flooding during the storm.

At least the material at those sites is replaceable. What about the nearly 15 million pounds of gold bricks stored at the New York Fed?

They’re safe—and will be, in theory, should floodwaters return. The bullion is so heavy that its vault sits 80 feet below street level, and 50 feet below sea level, on the bedrock beneath Manhattan. Though the bank’s fortress-like building is located far downtown, close to where other financial institutions sustained water damage, the property at 33 Liberty St. sits in the city’s evacuation zone C, where residents are told to expect storm-surge flooding only from major, category 3 or 4 hurricanes that hit the New York harbor.

The New York Fed is tight-lipped about how it secures the planet’s largest concentration of gold, referring questions on the subject to a brochure (PDF) published on its website. The pamphlet claims that the vault is protected by an “airtight and watertight seal” created by lowering a 90-ton steel cylinder just three-eighths of an inch into a 140-ton steel-and-concrete frame—an effect “similar to pushing a cork down into a bottle.” Other security measures include closed-circuit video feeds, firearms training for guards, and the weight of the gold itself. At 27 pounds per bar, it’s hard to smuggle one out in a pocket. “The Bank’s security arrangements are so trusted by depositors that few have ever asked to examine their gold,” the New York Fed writes.

That, obviously, has helped fuel a string of conspiracy theories—the gold isn’t really there, isn’t really gold, or is otherwise suspect. The Los Angeles Times reported in August that the federal government was conducting its first-ever audit of the bullion it stores beneath Liberty Street, drilling tiny holes into selected ingots and analyzing the metal.

Ordinarily, you’d be able to eye the gold bars yourself. Some 25,000 visitors tour the bank’s vault each year. Those visits, the bank says, have been canceled indefinitely “due to the aftermath of Hurricane Sandy.”

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Newspaper discloses new Cameron text messages

LONDON (AP) — A British lawmaker says he’s asked the country’s media ethics inquiry to consider newly disclosed text messages sent between Prime Minister David Cameron and Rebekah Brooks, the ex-chief executive of Rupert Murdoch‘s British newspaper division.

The Mail on Sunday newspaper on Sunday published two previously undisclosed messages exchanged between the pair, who are friends and neighbors.

Brooks is facing trial on conspiracy charges linked to Britain’s phone hacking scandal, which saw Murdoch close down The News of The World tabloid.

In one newly disclosed message, Cameron thanked Brooks in 2009 for allowing him to borrow a horse, joking it was “fast, unpredictable and hard to control but fun.”

Opposition lawmaker Chris Bryant has asked a judge-led inquiry scrutinizing ties between the press and the powerful to examine the messages.

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“Wreck-It Ralph” hammers box office, sails over “Flight”

LOS ANGELES (Reuters) – “Wreck-It Ralph,” Disney‘s animated film about a videogame character who destroys everything in his path, scored the highest-grossing opening weekend in Disney animation history with $ 49.1 million, as box office attendance picked up in the aftermath of superstorm Sandy.

The tally for “Wreck-It Ralph,” which features the voices of John C. Reilly and Jane Lynch, hammered the Denzel Washington film “Flight,” which generated ticket sales of $ 25 million at U.S. and Canadian theaters, according to studio estimates on Sunday.

After a quiet box office last weekend with the U.S. East Coast preparing for superstorm Sandy, there was a jump in movie attendance this week in areas hit by the storm.

Dave Hollis, executive vice president of film distribution at Walt Disney Studios, told Reuters that movie attendance in affected areas was “very healthy,” boosted by school closures on Friday, which saw a bounce in matinee showings.

“In a nice way, ‘Wreck-It Ralph,’ in areas affected by the storm, ended up actually becoming an opportunity to relieve yourself from the reality that might be going on around you, we saw the theater business around areas affected by the storm very healthy,” Hollis said.

“The storm and its impact – I don’t know if it was a function of cabin fever or just escaping by getting into a movie theater, but there was definitely a gravitating-towards-the- theater phenomenon.”

Disney had developed “Wreck-It Ralph” for more than a decade and spent an estimated $ 165 million to produce the film, which featured cameo appearances by a Pac-Man ghost and Mentos candy.

The film was produced by the same team behind Disney‘s animated film “Tangled,” which earned the previous highest opening weekend gross with $ 48.8 million in 2010. “Wreck-It Ralph” was forecast to generate sales in the mid-$ 40 million range, according to Paul Dergarabedian, president of the box office division of Hollywood.com.

New release “Flight,” in which Washington stars as an airline captain who saves his plane from crashing but is accused of drinking before the flight, beat industry analysts’ $ 13 million forecast. The film, produced by Viacom’s Paramount Pictures unit, was made on a $ 31 million budget.

STORM BOOST

Unlike “Wreck-It Ralph,” “Flight” did not experience the same benefit from school closures in parts of the East Coast, according to Don Harris, president of distribution at Paramount Pictures.

“The Disney movie would benefit from school being out in a large number of big urban and suburban eastern markets, they were always going to have a very good opening, I think they got a little help on Friday,” Harris told Reuters.

He also said that the target adult audience for “Flight” would have probably been occupied with Tuesday’s presidential election and being “more active in helping people in their neighborhood” in the aftermath of Sandy, and not necessarily attending theaters this weekend.

“We did about what we expected to do but we certainly didn’t get a bump. I don’t think it hurt us very much either,” Harris said.

Critically acclaimed Iran hostage thriller “Argo,” last week’s box office leader, came in third this weekend after generating $ 10.2 million in sales.

Directed by and starring Ben Affleck, “Argo,” produced by Warner Bros. and GK Films for $ 44 million, is based on the true story of a mission to rescue U.S. government employees held hostage in Iran in 1979. It has totaled $ 75.9 million in three weeks at movie theaters and earned Oscar buzz after stellar reviews from critics.

New release “The Man With The Iron Fists” was unable to beat “Argo’s” momentum this weekend and came in fourth with ticket sales of $ 8.2 million.

Starring Russell Crowe and hip hop artist RZA, the film, produced on a budget of $ 15 million, follows a blacksmith in 19th-century China trying to defend his village from warriors and assassins searching for gold.

In fifth place, “Taken 2,” an action-thriller starring Liam Neeson as a former spy who is kidnapped in Istanbul, earned $ 6 million this weekend. It has generated a total of $ 125.7 million at the U.S. and Canadian box office since its release last month.

Overseas, the new James Bond film, “Skyfall,” enjoyed a stellar second weekend, earning $ 156 million in ticket sales at the international box office. The film will be released in North American theaters on November 9.

Walt Disney Co released “Wreck-It Ralph.” “Flight” was distributed by Paramount Pictures, a unit of Viacom Inc. Warner Bros., a division of Time Warner Inc, distributed “Argo.” Universal Studios released “Man with the Iron Fists.” “Taken 2″ was released by 20th Century Fox, a unit of News Corp.

(Reporting By Piya Sinha-Roy and Ronald Grover; Editing by Eric Beech)

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Turkish ex-president’s autopsy fuels poisoning speculation

ISTANBUL (Reuters) – An autopsy on late President Turgut Ozal, who led Turkey out of military rule in the 1980s and whose body was exhumed last month, will reveal he was poisoned, his son believes, calling for a full investigation of the “dark years” two decades ago when he died.

Ahmet Ozal was speaking after a newspaper report said high levels of poison had been identified by the autopsy, carried out after his father’s body was dug up on the orders of prosecutors investigating suspicions of foul play in his death.

State forensic authorities have denied the media report.

Ozal’s moves to end a Kurdish insurgency and create a Turkic union with central Asian states have been cited as motives for would-be enemies in the shadowy “deep state”, in which security establishment figures and criminal elements colluded.

Ozal died of heart failure while in office in April 1993 at the age of 65. After undergoing a triple heart bypass operation in the United States in 1987, he kept up a grueling schedule while remaining overweight until he died.

But his family believe he was the victim of a plot.

“Even though 19 years have passed, thanks to technological advances and rigorous investigation they are capable of finding poisonous substances … I believe they will be found,” former member of parliament Ahmet Ozal told Reuters late on Saturday.

“I am 100 percent sure his death was not normal. If it is indeed proven, then Turkey should thoroughly investigate the dark years,” he said, noting that top investigative journalist Ugur Mumcu was killed in a car bomb the year Ozal died.

It was Turkey’s military leaders who appointed him as a minister after a period of military rule following a 1980 coup.

Ozal went on to dominate Turkish politics during his period as prime minister from 1983-89. Parliament then elected him president, but those close to him believe his reform efforts displeased some in the security establishment.

While prime minister, Ozal survived an assassination attempt by a right-wing gunman in 1988 when he was shot at a party congress, suffering a wounded finger. Ahmet Ozal said he believed there was a cover-up over the assassination attempt.

“If the assassination (attempt) is investigated … we may see interesting connections to things happening these days. It could also offer an insight into my father death,” he said, noting a presidential order would be needed for such an investigation.

Turkish political history has been littered with military coups, alleged anti-government plots and extra-judicial killings. A court is currently trying hundreds of suspects allegedly linked to a nationalist underground network known as “Ergenekon” accused of plotting to overthrow the government.

Turgut Ozal‘s brother, Korkut Ozal, said in 2010 he believed Ergenekon had killed the president. ‘Extrajudicial killings’ were common at that time and have been blamed on shadowy militant forces with ties to the state.

STRYCHNINE CLAIM DENIED

Those suspicious about his death have pointed to efforts which Ozal made to end the conflict with Kurdish militants during his time in office, including securing a Kurdistan Workers Party (PKK) ceasefire shortly before his death.

A report in Bugun newspaper on Friday said it had obtained a copy of the autopsy which revealed high levels of “strychnine creatine” in Ozal’s body.

Strychnine is a highly toxic alkaloid used as a pesticide which causes muscular convulsions and death through asphyxia. Creatine is an organic acid which supplies energy for muscle contraction.

However, the head of the state forensic medicine institute, Haluk Ince, said such a substance had not been found and the report had not yet been completed.

“We did not find the material referred to in the newspaper story. We don’t know how that story came about,” Ince told reporters in the wake of the Bugun article, adding the institute aimed to complete its work in December.

No post-mortem examination was conducted at the time of Ozal’s death, reportedly at the request of his widow.

Viewed as a visionary who helped pave the way for the free market economic policies under which modern Turkey has thrived, Ozal also gave firm support to the West, supporting the U.S.-led coalition which expelled Iraq from Kuwait in 1991.

Ahmet Ozal said his father helped transform Turkey from a coup-torn, state-run economy to the emerging power it is now, boosting freedom of expression, religion and private enterprise.

“This was the foundation that gave birth to modern Turkey. Along with this, perhaps the most important was the transformation of people’s mindset. With that you can change anything,” he said.

(Writing by Daren Butler; Editing by Jon Hemming)

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