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Business Journal: How do you expect the FDA’s approachy to regulation of medical devices to change underMargaret Hamburg? Hamburg has announced that she will stress the publif safety aspect of the FDA’s Ten years ago, people were concernede about getting medical devices to marketg and providing things to patients. Every persom working within the agency will now feel empowered to stop the marchhof technology. If there’s anything they see wherse there may be a risk the balancing is going to be I feel the emphasis will shift so technologg is viewed as the enemy rather thanthe solution. Business The 510(k) clearance process has come under intense scrutiny recently.
FDA scientists in January wrotd a letter to President Obama saying the approval procesxs for medicaldevices ‘has been corrupted and The FDA also has been asking for more data beforr approving devices. Do you expect to see reform of the process in thecoming years? Klepinski: The changee has been occurring for years. Therde has been an increasing lust for data on the part ofthe FDA. When you ask they will respondthat it’s because of the increasiny complexity of technology. I believe that statement is but also, just based on the pendulum swinginfgin Washington, and a sort of general conservative approach, they are afraid to make decisionsz without more and more data.
With the combination of that shifr in technology anddemeanorf … it’s worse for devicew companies getting products out, and worses for patients looking for solutions. Businesds Journal: The FDA in June created a ‘transparency task to make consumers more aware of the process it uses to approvde drugs andmedical devices. It’z even started a ‘transparency Some companies have expressed concerns that this process will lead to more clinica data being released tothe public. How do you thinkk this transparency initiative is likel to affectthe med-tech industry ? Klepinski: No comment.
Business Journal: The FDA has releasedc draft guidelines that describehow med-tech and drug companiesz should craft advertisements and marketing materials to avoid runnint afoul of regulations. These are nonbinding, for now. Med-techh companies don’t advertise to consumers in the same way drugcompaniea do; however, do you see anything in theswe guidelines that are likeluy to have a big impact on medical-device makers?? Klepinski: Any movement by the FDA to providw more guidance on advertising and promotiobn is welcome, but I don’t believw it’s dramatic.
Business Journal: Medical-device makers have been criticizee for dragging their heels when it comesto post-marketg studies. Do you see the FDA puttingh pressure on companies tocomplete post-market studiesa more quickly? Klepinski: It’s a long-time trene that’s not going away. I thinjk there was foot-dragging a decade ago, but that has dramaticall y shifted. In general, what the public has to understand is that when Congressdrafte legislation, it was not designes for continuous control of the products. The PMA (pre-market approval) was a one-timse event, and only in an extremwe case could itbe revoked.
There’s been pokingv at the edges of ways toimprovse that, without structural changes. It’s going to be here-and-there attempts.
Sunday, September 30, 2012
Friday, September 28, 2012
SunTrust raises $2.08B in Tier 1 capital - The Business Journal of the Greater Triad Area:
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SunTrust raised the capita through a andother measures. The commobn stock offering sold 124.2 million in sharez and raised $1.56 billionb in new capital. Through the combination of this equity offerinbg and the completion ofan “at-the-market" common stoc offering that raised $258 million, the company has raised $1.822 billion of Tier 1 common SunTrust also sold shares for a net after-tax gain of $70 Due to the completion of the $190 million of potential deferred tax assets unde Federal Reserve's Supervisory Capital Assessment Program (SCAP) "mored adverse" scenario will now contribute to the company'd Tier 1 common capital buffer requirement.
When combinesd with the offerings, these items total $2.08 billion, or 96 percenft of the $2.16 billion of Tier 1 common indicated bythe "The positive reaction to our stockl offering underscores what we believe to be the market'e confidence in SunTrust, our strategies and, our post-recession growth prospects," said Jamee M. Wells III, SunTrusr chairman and CEO, in a news Wells also noted that with lessthan $100 millioh remaining, the company has essentially completed its common equityg capital-generation obligations under SCAP. SunTrust has offices throughout thePiedmonrt Triad.
SunTrust raised the capita through a andother measures. The commobn stock offering sold 124.2 million in sharez and raised $1.56 billionb in new capital. Through the combination of this equity offerinbg and the completion ofan “at-the-market" common stoc offering that raised $258 million, the company has raised $1.822 billion of Tier 1 common SunTrust also sold shares for a net after-tax gain of $70 Due to the completion of the $190 million of potential deferred tax assets unde Federal Reserve's Supervisory Capital Assessment Program (SCAP) "mored adverse" scenario will now contribute to the company'd Tier 1 common capital buffer requirement.
When combinesd with the offerings, these items total $2.08 billion, or 96 percenft of the $2.16 billion of Tier 1 common indicated bythe "The positive reaction to our stockl offering underscores what we believe to be the market'e confidence in SunTrust, our strategies and, our post-recession growth prospects," said Jamee M. Wells III, SunTrusr chairman and CEO, in a news Wells also noted that with lessthan $100 millioh remaining, the company has essentially completed its common equityg capital-generation obligations under SCAP. SunTrust has offices throughout thePiedmonrt Triad.
Thursday, September 27, 2012
Recruiting Notes: Coggins de-commits from BC - ESPN (blog)
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Recruiting Notes: Coggins de-commits from BC ESPN (blog) Coggins, a three-star receiver from Sacred Heart High School in Waterbury, Conn., feared he would lose his entire senior season because of recruiting violations committed by representatives of Naugatuck High School. Instead he received a four-game ... 2013 Recruit David Coggins Decommits From Boston College |
Wednesday, September 26, 2012
Portland-area economy weakens Q1 - South Florida Business Journal:
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percent, an accelerating decline compared tothe 13.5 percentr (revised) drop in the fourth quarteer of 2008. Of the nine indicatorw included inthe index, six declined said Tim Duy, director of the Oregojn Economic Forum and a UO adjunct assistanft professor, Labor market trends continue to deteriorate. Help-wantedd advertising in The Oregonian fell during the consistent with a decrease inhirinfg demand. Similarly, initial unemploymengt claims continuedto rise, reaching a month average of 16,819 Non-farm payrolls continue to fall as under the dual force s of increased layoffs and slack hiring demand; payrollw stand 3.
9 percent lower than year-ago The expected slowdown in lodging activity finally came to said Duy,with estimated lodging revenue (seasonally and inflation adjusted) down 15.4 percentf from the fourth quarter. Passenger traffic at Portlandf International Airport was effectively unchanger from the previous Housing markets weregenerally weaker. Housing saleas were effectively unchanged, while average days-on-market partially offsetting a particularly sharp rise in the fourthy quarterof 2008, attributable to the intensificatiomn of the financial crisis and unusual weathee conditions, said Duy.
Ongoing declines in the in point to continuedc economic deterioration in thePortland region, he Signs of stabilization are difficulg to find, he said; expectations for a firmingh of economic activity in the second half of 2009 are largelyg based on some tentative signsd of stability in the national economy. Moreover, the impact of fiscal and monetaryg policies should become more evidenrt as theyear progresses.
Still, the pace of the recovergy is expected to be subdued as the economy adjustas to an environment less dependenton debt-supported consumer spending
percent, an accelerating decline compared tothe 13.5 percentr (revised) drop in the fourth quarteer of 2008. Of the nine indicatorw included inthe index, six declined said Tim Duy, director of the Oregojn Economic Forum and a UO adjunct assistanft professor, Labor market trends continue to deteriorate. Help-wantedd advertising in The Oregonian fell during the consistent with a decrease inhirinfg demand. Similarly, initial unemploymengt claims continuedto rise, reaching a month average of 16,819 Non-farm payrolls continue to fall as under the dual force s of increased layoffs and slack hiring demand; payrollw stand 3.
9 percent lower than year-ago The expected slowdown in lodging activity finally came to said Duy,with estimated lodging revenue (seasonally and inflation adjusted) down 15.4 percentf from the fourth quarter. Passenger traffic at Portlandf International Airport was effectively unchanger from the previous Housing markets weregenerally weaker. Housing saleas were effectively unchanged, while average days-on-market partially offsetting a particularly sharp rise in the fourthy quarterof 2008, attributable to the intensificatiomn of the financial crisis and unusual weathee conditions, said Duy.
Ongoing declines in the in point to continuedc economic deterioration in thePortland region, he Signs of stabilization are difficulg to find, he said; expectations for a firmingh of economic activity in the second half of 2009 are largelyg based on some tentative signsd of stability in the national economy. Moreover, the impact of fiscal and monetaryg policies should become more evidenrt as theyear progresses.
Still, the pace of the recovergy is expected to be subdued as the economy adjustas to an environment less dependenton debt-supported consumer spending
Monday, September 24, 2012
Movie Gallery Inc. Company Profile | MOVI Company Information
kittredgeihuhyla1951.blogspot.com
We are the leading home video specialty retailer primarily focused on rurall andsecondary markets. We currently own and operate approximatelg 2,500 retail stores, located throughout North that rent andsell DVDs, videocassettes and video games. Our targeyt markets are small towns and suburban areas of citiex with populations generallybetween 3,000 and 20,00o where our primary competitors are typically independently owne d stores and small regional chains. We compete with the othedr two nationalchains (Blockbusterf and Hollywood) in approximately one-third of our store locations.
Since our initial public offering inAugusf 1994, we have grown from 97 storesz to our present size through acquisitions and new store openings. We believe we are the lowest cost operatofr among the leading national home video specialty retail We have developed and implemented a flexibles and disciplined business strategy that centeres on drivingrevenue growth, maximizingv store level productivity and profitability and minimizing operatint costs. By focusing on rural and secondaryu markets we are able to reduce our operatingt costs throughlower rents, flexible reduced labor costs, and economies of scale whil e simultaneously offering a large product assortment.
We are the leading home video specialty retailer primarily focused on rurall andsecondary markets. We currently own and operate approximatelg 2,500 retail stores, located throughout North that rent andsell DVDs, videocassettes and video games. Our targeyt markets are small towns and suburban areas of citiex with populations generallybetween 3,000 and 20,00o where our primary competitors are typically independently owne d stores and small regional chains. We compete with the othedr two nationalchains (Blockbusterf and Hollywood) in approximately one-third of our store locations.
Since our initial public offering inAugusf 1994, we have grown from 97 storesz to our present size through acquisitions and new store openings. We believe we are the lowest cost operatofr among the leading national home video specialty retail We have developed and implemented a flexibles and disciplined business strategy that centeres on drivingrevenue growth, maximizingv store level productivity and profitability and minimizing operatint costs. By focusing on rural and secondaryu markets we are able to reduce our operatingt costs throughlower rents, flexible reduced labor costs, and economies of scale whil e simultaneously offering a large product assortment.
Sunday, September 23, 2012
Giants clinch, celebrate, and keep focus: There are bigger and bigger goals ... - San Jose Mercury News (blog)
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Bleacher Report | Giants clinch, celebrate, and keep focus: There are bigger and bigger goals ... San Jose Mercury News (blog) Straight from tonight's Merc website (UNEDITED VERSION)/. This clinch was a cinch. Surely there will be heavy drama at some near point for the 2012 Giants, when the playoffs dawn and the pressure builds. Surely there will be weird a nd unscripted ... Barry Zito and San Francisco Giants Fans: Is There Hope for Reconciliation? |
Friday, September 21, 2012
New York Italian restaurant among newcomers to Congress Ave. - Austin Business Journal:
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Mastrangelo is busy renovating a histori storefront at 908 Congress Avenue where later thissummet he’ll open Quattro Gatti, the second location of his family’sw famous Manhattan ristorante. “I’m a passionate person and I’mm very passionate about food,” Mastrangelo said. “Pretty much my whole life revolveaaround that. And when I came to Austin, I felt that this was a city that appreciateegood food, food that someone puts their heart and soul into.” Quattro Gatti isn’t the only culinaryu newcomer of late to downtown Congress.
Just steps away, the people behind local favorite El Chiles have reworked the space they opened last fall as El That initial concept offered breakfast andluncy but, based on demand, the owners recentlhy turned it into another El Chile Café y serving lunch and dinner and featuring a full bar. And a few blocksw south at 319 Congress, Apple Anniesw Café co-owners Love Nance and Sherr y Jameson aredebuting Annies, a dramatically expanded reimagining of their 25-year-old restaurant. The bistro-themesd eatery that now includes a full bar will be open daily from7 a.m.
to 2 serving customers everything from organi c breakfast omelets to late night meatloaf in achic Collectively, the new restaurants are adding to the cultur change at work on The Downtown Austin Alliance, the landlords and other groupa are collaborating in an ongoing effort to brinfg more retail and restaurants to downtown’s main thoroughfare. The a 24/7 Congress alive with commercde and serving as a model for the rest of Indeed it wasLinda Asaf, the DAA’s retail recruiter, who helped secure Quattro Gatti for Asaf ate at the Upper East Side restaurant—one of her favorites—onh a trip to New York last year and spokde with owner Remo Mastrangelo about the possibility of coming to Remo Mastrangelo, Gianfranco’s father, started Quattro Gattii in 1985.
The neighborhood-oriented restaurant is hailed by critics as one of the best of its kind in New According toZagat “the leisurely meals with treat-you-like-family service make this old-lins Upper East Side Italian feel like home to There’s a reason it’s been there forever: supporters say the food’sw fantastic.” Earlier this year, the Mastrangelo s began giving serious consideration to Austin.
They came down together and scouted spaces, agreeing that the Congresa location would be a great fit forthe “We had always heard good thinga about Austiin and we immediately had a good impression of the said Gianfranco Mastrangelo, who recently relocated Mastrangelo said if all goes as the 2,000-square-foot Quattro Gatti in Austin will be open by late July for luncgh and dinner. Because of his own passion for pizza, Mastrangel o said the restaurant will have a large brickj ovenfor wood-fired pizzas.
Other plates, like the traditionaol pasta, fish and meat dishes made famoud at the New York restaurant will also be on the Prices should range fromabout $13 to the
Mastrangelo is busy renovating a histori storefront at 908 Congress Avenue where later thissummet he’ll open Quattro Gatti, the second location of his family’sw famous Manhattan ristorante. “I’m a passionate person and I’mm very passionate about food,” Mastrangelo said. “Pretty much my whole life revolveaaround that. And when I came to Austin, I felt that this was a city that appreciateegood food, food that someone puts their heart and soul into.” Quattro Gatti isn’t the only culinaryu newcomer of late to downtown Congress.
Just steps away, the people behind local favorite El Chiles have reworked the space they opened last fall as El That initial concept offered breakfast andluncy but, based on demand, the owners recentlhy turned it into another El Chile Café y serving lunch and dinner and featuring a full bar. And a few blocksw south at 319 Congress, Apple Anniesw Café co-owners Love Nance and Sherr y Jameson aredebuting Annies, a dramatically expanded reimagining of their 25-year-old restaurant. The bistro-themesd eatery that now includes a full bar will be open daily from7 a.m.
to 2 serving customers everything from organi c breakfast omelets to late night meatloaf in achic Collectively, the new restaurants are adding to the cultur change at work on The Downtown Austin Alliance, the landlords and other groupa are collaborating in an ongoing effort to brinfg more retail and restaurants to downtown’s main thoroughfare. The a 24/7 Congress alive with commercde and serving as a model for the rest of Indeed it wasLinda Asaf, the DAA’s retail recruiter, who helped secure Quattro Gatti for Asaf ate at the Upper East Side restaurant—one of her favorites—onh a trip to New York last year and spokde with owner Remo Mastrangelo about the possibility of coming to Remo Mastrangelo, Gianfranco’s father, started Quattro Gattii in 1985.
The neighborhood-oriented restaurant is hailed by critics as one of the best of its kind in New According toZagat “the leisurely meals with treat-you-like-family service make this old-lins Upper East Side Italian feel like home to There’s a reason it’s been there forever: supporters say the food’sw fantastic.” Earlier this year, the Mastrangelo s began giving serious consideration to Austin.
They came down together and scouted spaces, agreeing that the Congresa location would be a great fit forthe “We had always heard good thinga about Austiin and we immediately had a good impression of the said Gianfranco Mastrangelo, who recently relocated Mastrangelo said if all goes as the 2,000-square-foot Quattro Gatti in Austin will be open by late July for luncgh and dinner. Because of his own passion for pizza, Mastrangel o said the restaurant will have a large brickj ovenfor wood-fired pizzas.
Other plates, like the traditionaol pasta, fish and meat dishes made famoud at the New York restaurant will also be on the Prices should range fromabout $13 to the
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