FDA Calendar Overview Print
Sunday, 29 November 2009 18:29

The FDA Calendar database includes over 350 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

The FDA Calendar landing page includes a button - Press here to load the latest updates and data - that must be clicked in order to fill the calendar database with the latest information. From left to right, the columns include (1) Company Name, (2) Ticker, (3) Type (e.g. clinical trial, FDA decision, FDA resubmission, FDA new filing, etc.), (4) FDA Date (this is the estimated or published catalyst date for expected study results, FDA decisions, FDA filings, etc.), (5) Details (this is the most extensive entry which contains a text summary of the entry), (6) Last Update (the time / date stamp for the most recent update for each entry).

Some tips for using the FDA Calendar include the ability to sort the database by each column (other than details), which can be very useful, e.g. sorting by ‘Last Update' column yields all of the most recently updated entries. By default the FDA Calendar database is sorted by date in descending order (with catalyst dates that are furthest in the future listed first). Alphabetical sorts by company name or ticker are useful for finding specific companies in the FDA Calendar while sorting by Type groups pending FDA decisions, clinical trial results, FDA new filings, etc.

FDA Calendar Extreme Trades describe companies with market caps below $1 billion and / or single digit stock prices with pending catalysts in the form of FDA decisions, clinical trial results, and other FDA filings / re-submissions that are expected to have a major percentage impact on the underlying share prices of the affected companies.

Two general Extreme Trading strategies are outlined below and neither strategy involves holding the stocks through the actual binary event to mitigate the downside risk.

(1) buying a basket of stocks highlighted in extreme trade reports well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume with a goal of achieving possible returns of 50-100% without the risk of holding through the binary event; and

(2) momentum / day trading strategies for the stocks highlighted in my extreme trade reports in the days / weeks ahead of the expected binary event - taking advantage of the greatly increased stock price volatility and trading volume.

The FDA Calendar can also be used to hedge against upcoming binary events for companies held in an investment portfolio by retail or institutional investors and to monitor for competitors that have upcoming FDA decisions or clinical trial results. Click here for the current subscription options at, including the ability to sign up for the free email newsletter.

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