Archive for March, 2010:
FDA Drug Approval Process
The U.S. Food and Drug Administration (FDA) has the responsibility to determine if newly developed medical products are safe and effective. Whether it is a prescription medication, a medication sold over the counter, a medical device, a vaccine, or another type of biologic, the product can be marketed for general sale in the United States only if it has FDA approval.
FDA advisory committees are the most visible part of the FDA approval process. They meet in public to review the most controversial and cutting-edge medical products, examining applications for FDA approval. Committee members discuss the strengths and weaknesses of the studies and their enthusiasm or concerns about the medical product under review. At recent FDA advisory committee meetings on controversial drugs and medical devices such as Vioxx®, silicone implants, and antidepressants, the media have provided the Congress and the general public with a glimpse of the approval process.
FDA schedules meetings for several of its advisory committees, the outcome is almost certainly going to be FDA approval for the products under review. In most cases the advisory committee will recommend approval, but even products that are not recommended for approval are frequently approved by the FDA. Even lopsided votes against approval apparently do not have much weight, since the FDA subsequently approved many of those products.
Although FDA officials describe the advisory committees as providing diverse perspectives and expertise, the large number of unanimous or nearly unanimous votes suggests that either the data are exceptionally convincing or that the committee members are reluctant to disagree with their colleagues or believe that the FDA wants the advisory committee members to come to consensus.
By combining information from the NRC study with studies of conflicts of interest on FDA advisory committees, it is possible to understand how a few committee members with conflicts of interest can have a disproportionate impact on approval recommendations. NRC’s analysis of meeting transcripts indicates that many committee members’ votes seem inconsistent with their concerns about the safety or efficacy of the drug or medical device under review. These transcripts clearly illustrate the pressures that committee members describe to conform to their colleagues or to be able to vote ‘yes’ even if it means changing the wording of the question so that they can do so in good conscience. The report includes examples of committee members directly trying to influence the views or votes of other committee members.
If the FDA is relying on advisory committees to help determine the conditions of approval, one would expect that FDA officials would provide explicit oral instructions about the types of conditions that the FDA is willing to impose, and that the FDA would impose most of the conditions and then enforce them. That is not the case, however.
Committee members frequently recommended unenforceable or vaguely worded conditions of approval and expressed their intention to recommend approval for products that they did not believe were proven safe or effective. Their candor suggests that they would welcome guidance from the FDA officials present, to make sure their recommendations were appropriate. Nevertheless, during committee discussions FDA officials showed remarkably little interest in providing oral guidance regarding the criteria for approval, or the realities of approval conditions to advisory committee members during the eight years of the study. Conditions of approval imposed by the FDA often did not reflect the conditions recommended by the advisory committees. Conditions that were imposed were rarely enforced.
Overall, the findings indicate that committee members, intentionally or unintentionally, move toward a consensus that often seems inconsistent with their differing views or perspectives in making decisions that may have life-or-death consequences for millions of Americans. Voting for approval contingent upon conditions is a popular compromise, but the FDA does not impose most of the specified conditions on the companies when it grants approval. The Committees’ tendency toward approval seems to reflect the FDA’s goals; in fact, the FDA appears to be even more geared toward approval than the advisory committees. The FDA approved almost all the prescription drugs and devices recommended by the advisory committee, and also frequently approved products that were opposed by the committee members.
Whatever the reasons, many of today’s FDA drug and device advisory committees are rubber stamps for approval almost every time they meet. Moreover, even when an overwhelming majority recommend “nonapproval,” there is a good chance that FDA officials will approve the product anyway. Approval is even more likely for medical devices than it is for drugs.
How To Read Stock Charts?
Charting stocks is no different than doing science experiments in school. You collect data (stock prices) and then that data is plotted so you can see the overall big picture of what is going on.
Based on how the stock chart looks, you will devise a trading plan and trade in the direction of the trend.
Charting stocks can protect you from big losses and help you further your option trading gains. In order to fully take advantage of what the chart is telling you, you must first understand the basics of reading stock charts.
What is a Stock Chart
A stock chart is simply a graphical representation of the stocks price over a set period of time. The chart shows you at a glance how a stock has performed.
There are three 3 basic types of stock charts (bar, line, and candlestick) and depending on your trading style, each chart will serve its own unique purpose. Regardless of what type of stock chart you use, all three do nothing more than reveal the buying and selling patterns of the investors.
This is something that is hard to discern by reading stock quotes in the daily newspaper. That is why charting stocks has become so invaluable.
4 Key Areas of Every Stock Chart
There are 4 key areas you want to become familiar with when charting stocks:
Identification Section
Time Frame
Volume Bars
“X” and “Y” axis
For our example we will be using Potash Corporation.
Identification Section
Company Name: Potash Corporation
Stock Exchange Where Traded: New York Stock Exchange “NYSE”
Trading Symbol: POT
Current Date: (top left corner)
Days Price Change: opening price, days price high, days price low, and closing price
Volume: how many shares of the stock were traded for the particular time period
Change: this is the day’s dollar change compared to yesterday’s closing price. The dollar change and the percent change will be listed.
Time Frame: the chart will display what time frame you are viewing (1 year, 6 months, etc.). It is highly recommended to change the time frame to one that suits your trading style. Looking at a 3-6 month chart is necessary if you have a short term investing plan, and 1-5 years if you have a long term investing plan.
Volume Bars: volume is often called the heart of the stock market. It’s a key indicator of supply and demand. By looking at the volume bars you can get a good feel for the strength behind the stock price movement. A stock moving higher on heavy volume is much more likely to continue climbing than one that is moving higher on light volume.
“X” and “Y” axis: the “X” axis is the bottom portion of the graph, running horizontally, and it flows left to right. It’s the portion of the graph that has the time frame that you are looking at. The left side is the past and the right is the present. We use the past as a reference, but we trade from the right side of the chart. We trade what we see now.
The “Y” axis is the right side of the chart, running vertically, and flows top to bottom. This portion of the graph has the price action.
Essentially for the beginner, charting stocks boils down to three things:
*You’re going to look at the correlation between a stock’s price and volume activity (as shown by the price and volume bars).
*You’re going to look at the chart and determine if the stock’s price has been trending up or down. If it’s been trending up, I buy call options. If it’s been trending down, I buy put options.
*You’re going to determine where the stock’s support and resistance levels are. Support and resistance are areas where the stock has had trouble proceeding past, or an area where the stock halts and changes direction.
A stock chart can provide you with a wealth of knowledge as long as you know and understand what you’re looking at. Basic charting knowledge combined with other stock indicators can immensely improve your trading skills.
More Banks Are Closing Down
This year, 30 American banks have already collapsed and the numbers are expected to rise in the coming weeks. On an average, ten banks are closing down every month as banking sector continues to grapple with failures.
A staggering 184 banks have folded up since the bankruptcy of the then Wall Street major Lehman Brothers in September 2008.
Going by the official data, four entities were shut down by the authorities last week. Park Avenue Bank, Statewide Bank and Old Southern Bank failed on March 12 while LibertyPointe Bank collapsed on March 11.
The Federal Deposit Insurance Corporation (FDIC), which insures deposits at over 8,000 American banks, said these four failures would cost the agency $208.2 million.
Small and medium banks are hit the most, since high unemployment levels are resulting in rising defaults.
Despite a shaky labour market, the US economy has been growing at a healthy pace in the past few quarters.
Eight banks have gone belly up so far in March. Last month, seven entities failed while the count of collapses stood at 15.
Biotech Stock Investing Guide
Biotech Stock Investing Guide
What is Biotechnology?
Biotech is usually used to refer to a higher level of technological intercession.
Biotech can be used to create substances for medical use or to directly aid the body in fighting a disease or illness. The practice of genetically modifying yeasts and bacteria to produce drugs is one widespread use of red biotech, often allowing for the creation of drugs that would otherwise be impossible to manufacture. Manipulating a patient’s genome to cure a disease is another, relatively new use of biotech.