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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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Financial Stability FOrum will be renamed the Financial Stability Board and include 10 additional members, These additional members are from developing countries or emerging markets, including Argentina, Brazil, South Africa, and China. This forum which currently brings together regulators, central bankers and finance ministers from a few wealthy nations, will now reflect the views of emerging countries. It previously only served as aforum for exchanging ideas. Now it will be given the task of drafting the detailsfor global standards for financial institutions, including benchmarks for executive pay and how much risk that financial firms can take on. But there is still some resistance to the idea of getting ideas from different sources and including the benefit of a diversity of experiences and backgrounds, even though some of these countries, have borne the brunt of these recurring economic crises in the past, as have Argentina, Brazil and Mexico. Howard Davies, director of the London School of Economics says that you have to hear out China but objects to taking advice from Argentina, a comment which reveals the insular nature of these forums and boards in the past, with little or no representation from places where a majority of the word's peoples live. As would be expected in the light of that comment, there is resistance to giving China, India, Brazil, Russia, and other large developing countries like Mexico, South Korea, and Saudi Arabia proper representation in the IMF's governing bodies, and having the rules changed so that the head of the IMF and other important staff members could be selected from emerging countries. Each of these countries can bring adifferent perspective to the decisions made at the IMF, as most of them have suffered from these recurring economic crises in the postwar period. South Korea's experience with the IMF is the most recent and is covered in the link to S. Korea and the IMF, and if reflected in the policy making at IMF could help it perform a more constructive role in this crisis. This is also the case with some of the other countries....

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Failure of governments throughout the Arab world to deliver in the areas of democracy, free expression, education, economic and social development.

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British prime minister David Cameron tells the House of Commons- after it is revealed that Barclays management set artificially low LIBOR rates- "We need to take action right across the board." CEO Diamond resigns. This was designed to avert regulator scrutiny of Barclays in the aftermath of the financial crisis of 2008.

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India's Foreign Investment Board clears investments by Vodafone and Tesco.

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Economic reform legislation in Israel that unwinds the large conglomerates in Israel, and limits concentration of wealth in a small number of business enterprises limiting competition.

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Indian foreign minister Jaishankar describes the highly eccentric situation of lack of US India close economic and defense cooperation for over 50 years, when the natural flow of cooperation one would expect between the land of Washington and Lincoln and the land of Vivekananda and Gandhi was interrupted. The current form of cooperation has existed for about 14 years and accelerated after prime minister Modi was elected in 2016. This was a turning point in the US India relationship and in India US economic partnership. After president Trump was elected Mr. Modi and Mr. Trump held a huge public gathering in stadiums at Houston and Ahmedabad, in a way that was never seen before between an Asian country and America. What changed? For one thing India had a great weight lifted from its shoulders with the removal of the erratic Nehru policies of post independence India of forming a non aligned bloc with countries like Egypt and Yugoslavia. These were policies that had no connection to India and its history as the civilization where the East has its roots in Vedanta and Buddhism. It also resulted in alienating the Dwight Eisenhower administration and administrations that followed after John F. Kennedy, as the Cold War intensified and most of Eastern Europe came under Soviet domination. India never gauged the effect this had on America after the Berlin crisis in 1948, the Hungarian revolution of 1956 and similar uprisings in East Germany, Poland, and the Czech Republic. Britain was no help even with the British Commonwealth, as the British perpetuated the idea that India was too divided to make up one country, having failed to grasp India's ancient civilization and  culture, and having built the Empire in India by using the division in the country. Mohandas Gandhi described this in Hind Swaraj in 1910 and told Indians that it was they who had invited the British into India, with rulers using military garrisons of the British commercial East India Company for help in their internal wars. Americans still unfamiliar with India till after 2000 simply accepted British colonial ideas about India. The new administrations in the US, the Trump and Biden administration, and the Modi administration in India have shaken this up and changed perceptions all around. Biden recently during the Modi visit to Washington DC said India US relations as he sees it would be "the closest on earth." So that today we have an ancient civilization roused to its depths in its youth for modernization, that extends from India to Indonesia all the way to Japan rooted in India's ancient civilization of Vedanta and Buddhism, with a population of about 2 billion people. That faces the US on its Pacific coast, united in its determination to build a new and common future with ideas of parliamentary democracy, participation of the people, and of modernization with science and technology, contributing to the betterment of all peoples. ...

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Finance professors and experts on internet IPO's, Ritter at the University of Florida and Aggarwal, are skeptical that average investors would make money on the Facebook IPO. Ritter's information base shows that from 1980 to 2009, the average IPO's would jump 18% on the first day and 21% in the next three years, showing that hype and marketing with restricted supply of shares relative to demand created can artificially increase the price on the first day. As average investors get to invest after the opening day and on less favorable terms than the insiders and bankers doing the IPO, its not such a good deal for the average investor. Google performed well for the average investor, but this could be the exception rather than the rule. Google operates in a space, namely "search" engine, that is an essential part of the functioning of the internet space, which accounts for its continued growth. This may not be true for game firms such as Zynga, group discount sites such as Groupon, and social network sites such as Facebook, because their growth could stall suddenly. As Jason Zweig points out in the Journal, another factor is the starting price. At a high enough starting price the risk for investors could be high and returns may be no higher than the average 6-7% range....

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UBS and Bank of America reach a settlement with Detroit before the city declared bankruptcy. The settlement was for interest rate swap contracts signed by Detroit officials in 2005, and settles the contracts for 75 cents on the dollar or $230 million. There is safe harbor for traders and banks in interest rate swaps or derivative contracts, so that the usual stay that blocks creditors from collecting debts does not operate. This kind of treatment for derivative contracts makes no logical sense in the context say experts. The swap contracts of 2005 were signed at a time the city took out a $1.4 billion variable interest rate loan to put into its pension funds, with the swaps as a hedge against rising interest rates. In fact Detroit is seeking a $350 million loan from Barclays Capital and it needs to resolve the swap for that loan. From this loan UBS and Bank of America get their $230 million leaving $120 million for streetlights, police and city services badly needed today. Public interest considerations of this kind were not considered by Congress when it made the rule for safe harbors universal in derivative contracts to reduce systemic risk of one financial institution dragging others into a systemic crisis. The safe harbor make it harder for a judge to say this thing smells and make attempts to change it. ...

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Ajami points out the risks of the deal secularists and liberals in Egypt have made in calling on the military to upset the elected government of prime minister Morsi. The liberals and the Muslim Brotherhood were both equally opposed to the military and police intervention in politics in the period following Mubarak's ouster. The six decade rule of the military in Egypt has little to show for it in the modernization of Egypt and improving economic conditions. Egypt has seen this script before, says Ajami of the Hoover Institution- in 1952 the military stepped in after corruption in the political parties and political violence. The results were dismal extending throughout the period of modernization in Asia and Latin America. It has left Egypt frightfully behind in most dimensions of education, healthcare, and technological progess. The lack of training in parliamentary and democratic governance, and in the institutions of democracy are painfully evident- the poor roadmap for democracy laid out by the military, followed by the election, the decrees and authoritarian style critics describe of prime minister Morsi in failing to incorporate liberal opinion in policy, and the flawed secularist calls for the military to overturn the elected government with only one year in office. These institutions will take a long time to build and require patience, flexibility and the gift of wisdom on all sides....

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BAE Systems has a $120 million contract to provide social anthropologists to the Defense Department of the USA. In December, L-3 Communications Holdings Inc. acquired International Resources Ltd, a Washington based economic-development firm which is different from its military advisory business. This is the way the Defense Department and the suppliers to the Defense department are changing in response to Defense Secretary Gates philosophy that economic development, rule of law programs and strategic communications and a whole host of soft power initiatives are essential needs, and to the new President's philosophy. Now US Defense suppliers Lockheed and Northrop are providing peacekeepers thorugh the State Department, and BAE SYstems is providing social anthropologists in addition to armored vehicles to go with US troops on village patrols. The State Department, Agency of International Development and a changing Defense Department are all getting the attention of suppliers who are building new relationships for new needs and new services tackle the issues of terrorism, poverty, drugs and crime that generate or exacerbate conflict in other countries. In the first budget presented recently Obama pledged $50 billion double the amount before for foreign assistance. A portion of the $130 billion requested for wartime operations in 2010 will be allocated to these new kinds of services which are more effective and generate better understanding and support for the US in other countries....

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Joe Nocera joins Simon Johnson and other experts in saying that Fed Governor Daniel Tarullo's suggestion to raise capital requirements of U.S. banks to 14% makes sense. He quotes Anat Admati, a fiance professor at Stanford Business School, who says the only way to get rid of bailouts is to raise capital requiremets to an adequate level. The Wall Street Journal editorial on June 16, 2011, also supports the higher Tarullo capital requirements. Why is it that European banks and the Basel III accords provide a 7% capital reserve requirement phased in over many years- to as far out as 2019- if this is the case? The European banks are in much worse shape than the U.S. banks especially with Irish, Greek and other debt on their books and Basel III is designed to accomodate this. The governor of the Bank of England, Mervyn King, is also advocating higher capital reserve requirements than Basel III, including the flexibility for countries like Britain and Sweden to set their own capital reserve requirements based on their own situation and the need to protect taxpayers. The U.S. stands to gain a lot from setting its own standards if France and Germany and other European countries decide to user lower standards through Basel III....

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The Wall Street Journal's reporting in Sept, 2011, on France's bank BNP Paribas. Contributor Nicolas Lecaussin quoted a BNP Paribas executive saying the bank no longer had access to dollar funding. There is a loss of dollar funding to French banks from U.S. money market funds as the funds reduce exposure and shorten maturities. Analysts point to the French banks having one of the lowest ratios of liquid assets to short term funding needs in Europe. This reporting was questioned by BNP Paribas and French government officials. This happened as central banks including the U.S. Fed intervened in markets in September 2011, to ensure full availability of dollar funding to French banks.

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U.S. Fed governor, Daniel Tarullo, said in a recent speech that U.S. financial institutions could be required to meet stronger capital requirements than the Basel international standards. The Fed is considering requiring the riskiest financial institutions to put aside 8.4% to 14% of capital. The Basel standards require institutions to gradually increase the capital cushions to 7% by 2019 from about 2% at this time. Less risky institutions would would have a smaller increase over the Basel standards- about 20% compared to the 100% increase over Basel for the riskiest institutions. Speaking at the Peterson Institute for International Economics, Tarullo said- "The regulatory structure ...should discourage systemically consequential growth or mergers unless the benefits to society are clearly significant." Tarullo said no one wants to see another TARP. Banks would have to build up their capital reserves using common equity and not other forms of less reliable capital such as contingent capital, where banks convert debt instruments into equity in an emergency. Tarullo emphasized the need for the U.S. to move beyond the Basel requirements, known as Basel III, because they are narrowly designed for individual institutions and do not adequately address the systemic risk. When there is a high degree of risk correlation among many actors in fast moving markets additional risks are created which require stronger capital standards. Tarullo said systemically important institutions have "no incentive to carry enough capital to reduce the chances of such systemic losses."...