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The use of fast track procedures under 510 K, for approval of Ren-Gen's Menaflex product to treat knee injuries. Under 510K rules for fast track no clinical trials are required, because the product is similiar to already existing products. Menaflex does not have asimiliar product, yet the FDA allowed Menaflex to be treated as fast track. The closest is orthopedic surgical operation, which is quite different. Menaflex is a C shaped pad used to repair a torn meniscus, a rubbery substance made from cow collagen that that acts like ashock absorber between the knee bones. Their is a booming market for meniscus repair among sports athletes. In fact originally Ren-Gen did not even apply as fast track, but only afte its clinical trials ran into trouble, did it try for fast track, which was turned down several times. At which point Ren-Gen got Democrats Senator Robert Menendez, Rep Frank Pallone, Chairman of the Health Subcommittee of the House Energy and Commerce Committee, Rep Rothman of Hackensack where Ren-Gen is based, and Senator Frank Lautenberg to intervene. At this point Senator Menendez and the others wrote to the FDA Commisssioner Dr Von Eschenbach, and Menendez spoke to the Commisssioner personally on the phone. After this intervention things started moving in Ren-Gen's dirtection, bypassing the FDA staffers who had reservations, and a special panel was appointed that again excluded anyone that had reservations, in an unusual procedure, which approved Menaflex. Now Congress and the Obama administration are being asked to review the whole process the FDA uses for medical devices because of the controversy this has caused about what is seen as unfair influence of companies in FDA approval process. Menaflex say those who had reservatoions faces alot of pounding and wear and tear between the knee bones and its safety and effectiveness needs to be proven before approval. It has been approved in Europe for afew years, but only 2800 patients have used it in Europe, only a small proportion of patients, and not enough is known about its effectiveness and any issues. ...

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The SEC requirement that companies disclose the ratio between median worker pay and the pay of senior executives. The SEC says it is putting out the rule as part of implementing Dodd-Frank legislation to control excessive executive pay. Companies will be allowed to survey a fraction of their workforce as appropriate for companies with global operations. Executive pay will include pension benefits and stock options under the new rule. A WSJ chart using information from the University of Southern California and the Bureau of Labor Statistics, shows the ratio between what CEO's on average make and rank and file workers make remained at about 30 times in the post war period till about 1970, a period of rapid growth in the U.S. economy. By 1980 this climbed to about 60 times and exceeded 100 times by 1990. The period of stratospheric growth for CEO pay and extreme widening of the gap then occurs between 1990 and 2000. By 2000 the dot com boom- telecom boom and the internet- creates a surge in executive pay reaching over 500 times. This drops to about 280 times in 2008 and picks up again to reach about 320 times in 2011. Many of the poor business practices, the excessive leveraging and risktaking in the financial industry, take place against this background of excessive pay for senior executives. Some of that risk was passed on to others through such methods as securitization in the period leading to the 2008 financial crisis, so that executives were compensated with higher pay for taking excessive risk that they personally or their companies did not assume. Dodd-Frank legislation following the 2008 financial crisis sought to correct this imbalance by having pay information disclosed. The excessive pay has also coincided with an increase in the frequency of boom-bust cycles in the economy. The busts prompted the needs for intervention by the U.S. central bank, the Federal Reserve, to drop interest rates more than would otherwise have happened during this decade, culminating in the huge bond purchases and monetary easing by the Bernanke Fed. The SEC under Mary Jo White is mindful of these distortions in the economy as a result of misallocation of resources based on excessive executive pay, and the need to take action before the next crisis. ...

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Exxon has cut costs of shale oil production by learning new cost efficient ways of getting the oil out of the rock. Exxon states it has cut costs by 20 to 25% for production in the Bakken from shale, making it possible to invest in shale oil production at much lower prices as the learning continues. This will be a factor for oil prices in future years.

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Ailworth and Faucon describe the ways in which shale oil producers such as Continental Resources in Texas and S. Dakota are responding to the drop in oil prices. One strategy adopted is to put off 60% of the expense of production by not completing the final stages of production of hydraulic fracturing, but keeping the wells ready so that production can quickly be ramped up if prices go to the $60-65 range. EOG Resources, Andarko, Apache, Chesapeake Energy, are also following this strategy. There are about 3000 such wells, not pumping but drilled and ready for hydraulic fracturing, according to RBC Capital Markets estimates. This strategy would mean large shale oil supplies well into the future to keep oil prices low. Production from lower cost wells continues with U.S. oil production climbing to a new high of 9.4 million barrels a day for week ending March 6, 2015, according to federal data. This shows that this is a new situation and the resilience of shale oil supplies may have been underestimated. Another strategy adopted by other large companies such as Exxon is to continue to develop technology by learning to get the oil out of the rock in the most cost efficient way. The capital investment in U.S. shale oil has dropped by $50 billion in 2015 compared to 2014. The number of oil rigs drilling declined to 866 in the U.S. by March 2015, according to Baker Hughes....

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The failure of the economics profession to produce any red flags for this economic crisis, and the failure of economists to come to any consensus on what works to come out of this crisis, along with the huge confidence with which the economics profession displayed as the economy sailed along in most of the post war years, is one of the very noticeable things as one reflects on what has happened. Journalists like Peter Coy at BW who wrote this report followed the housing market for BW and raised red flags long before the crisis hit, just by looking at the facts. So its clear that looking at the facts through the lens of a particular theory of economics, or the lens of some ideological bias, or the lens of triumphalism, can handicap economists. There are economists who believe in the stimulus, and economists who don't believe in a stimulus, and others who think the economy reaches equilibrium of itself if left alone, and economists who believe in tax cuts. Were it not for the fact that the risks in a time like this are really great in depending on one or the other for advice if things don't work out the way they think, this would not be such a big issue. But a lot hangs inthe balance. Which is why decisions are based on what is actually happening on the ground, and by getting a good sense of that, and a grasp of real conditions, and getting agood sense of what will work in that particular situation, and not just hoping that things will work out according to some theory or conviction in the mind. And those who execute or manage the economy instead of teaching a class, have to be aware of the great responsibility for the lives of millions of people here and in poor countries around the globe, whose lives and the lives of their children, nutrition, health and education depend on their decisions, not just when they are in office but years after they have left. And for this reason exercize needed caution....

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Steve Bannon is described in this indepth report by Scott Shane as a workaholic, born to working class family with his father a telephone line operator, who went to Virginia Tech and joined the Navy in the hope of advancing a career in politics. At Virginia Tech he won a leadership position of the student organization. He was described by another student who knew him well as passionate but not likely to get much done. The period at Virginia Tech and in the Navy were the Carter years followed by election of Ronald Reagan. The election of Reagan had a huge influence on Bannon- the same overtones of that campaign of Reagan are seen today in the forgotten men and women, white working class families that Conservatives then and Tea Party Conservatives in the Obama years felt ignored. The downward drift of the lower middle class families that saw incomes drop as manufacturing hollowed out in the U.S. with foreign competition, the failure of establishment politicians of both parties to protect American manufacturing and working class families, added to the sense of angst for Bannon. Bannon just like politicians in the Obama camp such as Emmanuel, found the way to politics through finance and gains made as the banking sector and financial institutions made huge financial gains by 2008. This was a stepping stone for their political ambitions. Emmanuel who is also a workaholic and passionate about his views worked to elect a black president, Bannon choosing to do the opposite and push for bringing back the Reagan era. Most on the liberal side see him as part of a racist movement. Reagan was none of those things. How does one reconcile the two? It is possible that seeing the fight against the established politics as an impossible task, Bannon in his passionate temperament did not object to the support of right wing extremists, in the same way that Trump did. As both Trump and Bannon have people of Jewish origin and black people in their circle of friends or family. What incensed Bannon as described here by Scott Shane of the NYT, was that after the financial crisis of 2008, hardly any bank executives who had committed wrongdoing went to jail, his father's line operator retirement savings were devastated by the financial crisis, and working class families struggled harder than ever, that his daughter at West Point was with mostly children of working class families who were the ones fighting America's wars. Many ironies abound in the story. Bannon got his business start in the same financial institutions that were involved in the financial crisis of 2008, Bannon & Co was acquired by Societe Generale. He is from an Irish Catholic working class family in Richmond and attended Benedictine High School, with a mother Doris that worked on the campaign to elect Douglas Wilder, a Democrat, as the first African American governor of Virgina.  The other ironies are in that Bannon sees Trump as "an imperfect vessel" but still good enough, and Trump sees himself as "making all the decisions" when asked about Bannon, as a range of interests struggle to form a coherent movement on the right in American politics- an unlikely combination of a telephone operator's son and real estate magnate's son who built his own real estate business in luxury real estate towers far removed from ordinary men and women they represent. ...

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Annalena Baerbock, 44 years, of the Greens is Germany's nominee for president of UN General Assembly in 2025. She was nominated by chancellor Scholz. As a leader of the Greens and in the coalition government of chancellor Scholz she has tried to show that Germany is a modernizing nation and innovative more than is seen in its political class. As one of the youngest politicians she has presented Germany in a new way as a young face for Europe. DW.com shows the evolution of the Greens as a party since the 1980's. Baerbock joined the Greens at age 25, four years later in 2010 she was head of the Brandenburg state section of the party, becoming a board member of the European Green party. She is still only 44 years old. She studied public law and political science in Hamburg, and gained a Masters degree in international law at the London School of Economics, one of Germany's first leading politicians to study in Britain. She started studies for a Doctorate at the Free University of Berlin, which she left in 2013 as she was elected to the Bundestag. By 2021 Annalena Baerbock was with Robert Habeck co-leader of the party heading into the general election. At one point the Greens were polling 5 months before the 2021 election at 27% with Annalena Baerbock running for chancellor against Armin Laschet of CDU and ahead of the CDU by 3 points in Sonntag poll. The Greens came in at 15% of the vote in 2021 dropping slightly to 12% in 2025. This time the Greens will sit in the parliamentary opposition headed by Robert Habeck. ...

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This issue of the Economist magazine looks at Saudi oil price cuts and the future for shale oil in the world's energy mix. In the short run overleveraged companies in the shale oil business in the U.S. will be affected by oil prices below $50 a barrel. The Economist points out that shale oil deposits are extensive in the U.S. and other parts of the world. The upfront costs are as little as $1.5 million for drilling a well. As a result the economics of shale will depend on new advances in technology and efficiency to bring costs down below existing costs averaging of about $57 a barrel, with some producers at costs of $35 a barrel. Because of technology advances anticipated in the field it points to shale oil as a reliable source of low cost oil supplies in the future, keeping oil prices lower than in the past and much less subject to manipulation by cartel pricing or oil price shocks. The lower volatility and lower level of oil prices will be good for the rapidly growing economies in Asia and the developed economies of Europe and the U.S., and for countries in Latin America such as Argentina with large shale deposits....

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As stimulus money reaches factories making products like hybrid buses, another trend is working to undo the positive effects. States are cutting back on their orders as they face budget shortfalls. See link to states budget shortfalls. The New Flyer hybrid bus fatory in St Cloud, Minnesota, is one such factory. The Chicago Transit Authority used some of the stimulus money to buy 58 hybrid electric buses. At the same time Chicago had to put aside plans to order 140 more buses using state money which now has disappeared. According to the Center on Budget and Policy Priorities these effects of undoing, with one hand giving and another taking away are acting out across the economy. While the stiluus law cut federal taxes to put more money into the economy, about 30 states have raised taxes according to the Center. The Stimulus provides $27.5 billion in federal money on highway projects, but according to the American Road and Transport Builders Association, 19 states are planning to cut their highway spending in 2009. Even as the Stimulus provides $8.4 billion for mass tranisit, tranist systems are facing cutbacks in service and capital spending. Says Dean Baker, co-director of the Center for Economic and Policy Research, and author of a paper called "The State and Local Drag on the Stimulus," these cutbacks and the tax increases at the state and local levels are heading in the direction of offsetting much of the Stimulus impact....

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Mr. Acton and Mr. Koum, co-founders of Whats App messaging service have left the company after disagreements with Mr. Zuckerberg of Facebook. They say they had no intention of seeing Whats App turning into a clearing house for ads. Initially following the acquisition there was an agreement that advertising would not be the focus for Whats App, and the Whats App founders were given a large degree of autonomy. This has changed as Facebook uses data it collects to target audiences for ads on its services.

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Cook and Olson look at how U.S. shale oil firms have handled the slump in oil prices. Their report in WSJ says the shale firms have weathered the oil slump well, with production declines in 2016 of only 535,000 barrels a day compared to 2015. The Saudi decision to not cut production and let oil prices drop has affected mostly higher cost less flexible production for mega projects such as deep water projects and oil sands in Canada. Oil shale firms are expected to snap back, according to experts, as demand increases. U.S. production is expected to increase by about 700,000 barrels a day by end of of 2017, say experts.

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Simon Johnson, is Professor at MIT's Sloan School, senior fellow at the Peterson Institute of International Economics, co-founder of BaselineScenario.com a widely cited site on the global economy, and is a member of the Congressional Budget Office's Panel of Economic Advisors. Here he talks to the WSJ's Deal Journal reporters. He says the stress test don't mean much because the government using a milder scenario, made the banks look better than they really are. He suggests a wait-and-see strategy, as banks have 1 month to file plans on how they will raise needed capital and 6 months to do it. He sees a steeper yield curve on Treasury debt as a result, with long term Treasury securities like 20 year Treasury notes yielding higher than short duration securities, which should stimulate long term lending. Expect banks to issue more bonds than stocks which dilute shareholders value, and as bond prices are low. Johnson sees real risks of inflation in 1-2 years, becaue of the way the government has inflated the economy, in a manner he says like the private sector bubble. Expect the government to cut back to prevent this from happening. He also sees pretty good earnings in the financial sector in the second quarter which should help stocks. The question remains about how sustainable all this will be, because he says " the government by oversubsidizing the financial sector will get us stuck in the same kind of financial bubble that got us into the mess in the first place." ...

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Examination report of Deutsche Bank's regulatory reporting by the U.S. Federal Reserve Bank of New York in 2014 shows serious regulatory reporting problems.

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Deutsche Bank has lost two thirds of its share value and its leverage is extraordinarily high with total assets at 56 times tangible equity acccording to Morgan Stanley. Progress is being made but not enough say analysts, and raising capital now is better than waiting longer and doing that with a downward spiral in its shares. The loss announced January 14, 2009, of $ 4.8 billion euros for 4th quarter 2009, reflects a loss across all of the bank's businesses, and is a warning sign of the need to raise capital with greater urgency.

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Greece's economy is expected to shrink by 6% in 2012 by many private sector economists in Greece. This means Greece will have a deficit closer to 10% of GDP. Antonio Samaras, leader of the New Democracy Party, is expected to win the elections in Greece to be held by spring 2012. Opinion polls show his party getting 24% of the vote, and Papandreou's Socialists getting 15%, showing how little support any party can gather in Greece. Samaras told the Journal in an interview- the contagion is spreading rapidly, and what he fears is political and social contagion from high unemployment and austerity measures. Samaras says his government would continue with the spending cuts, but also reduce the tax burden on Greek households and businesses, which he views as having worsened the recession in Greece.

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Deutsche Bank posted a fourth quarter 2012 loss of 2.2 billion euros. It set aside 1 billion euros to cover the cost of legal settlements including an investigation of LIBOR rate manipulation. Deutsche Bank says it has raised its Tier 1 capital ratio to 8 percent from less than 6% a year earlier. Analysts are uncertain whether this is from changes the way the bank calculates risk and whether the bank has seriously reduced its high leverage.

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Patricia Kowsmann provides this picture of life in a town on Portugal's northern coast, Viana do Castelo, with a population of 87,000, as Portugal struggles to make a recovery. Viana do Castelo has shipyards and companies making metal bridges for highways. The money losing state owned shipyard was privatized and sold to Martifer SGPS SA to run till 2031. 600 workers at the shipyard were laid off. The new company plans to rehire 400 workers by 2016 but jobs will not be permanent. Companies making the bridges now sell to former Portuguese colonies of Angola, Mozambique, Brazil. 200,000 people have left the country to look for jobs or higer education, including the mayor's daughter in London. Exports are up and now make up 40% of Portugal's GDP, up from 27% in 2009. The economic growth is 0.9% in 2014, after declining 6% 2011-2013. Portugal accepted the last instalment of the bailout loan of 78 billion euros in 2014. It will auction 1.25 billion euros of bonds on July 22, 2015. Unemployment is now declining dropping to 14% from a high of 17%, and higher than the pre crisis level of 11%. Here in this coastal town the mayor Jose Maria Costa cut public employee salaries 15%, and also cut sports and cultural programs. Two food centers provide free lunch and dinner, and half of the 4000 children in school get subsidies for food and transport. A shipyard worker Antonio Gomes Barbosa 64, is one of the laid off workers. His son's architecture company closed and he left Portugal for Angola. Some of his co-workers now work at a shipyard in neighboring Spain....