The BioMedReports.com FDA Calendar database includes over 400 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. My FDA Calendar Extreme Trades article series highlights 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 Bio-Catalyst Extreme Trading Strategies are outlined below and as with previous installments this article is not an endorsement of the companies profiled or a complete list of extreme trades included in the FDA Calendar database. Please note neither strategy outlined below recommends holding the extreme trade stocks through the actual binary event to mitigate the downside risk; although it is also possible to let some profits ride through the event for a winning position if so inclined.

(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 stock prices for the FDA Calendar Extreme Trade stocks reflect intraday trading on the morning of 10/13/09 at the time of finalizing this report for publication and the companies are presented in alphabetical order by company name. A total of 85 companies are profiled in the extreme trade report today, with the majority of companies trading at below $5 per share, including free samples from the report for 10 companies with recent updates and / or possible near-term catalysts.

Click here for more information on becoming a premium subscriber at BioMedReports.com, which includes access to the full report on the extreme trades in the report today and access to the FDA Calendar database of over 400 entries.

On 7/23/09, Access Pharma (OTC: ACCP.OB) ($3.41) announced that its European partner, SpePharm, is collecting data from a post-approval marketing study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis (OM). In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any OM.

The encouraging interim results thus far for MuGard in the first 140 patients include some that have completed all seven weeks and others who are still pending completion in the study, and the final numbers for all 280 patients enrolled in the study are expected during early 4Q09. Also, MuGard is being evaluated in about 1,000 patients in Europe (Germany, Italy, U.K.) by SpePharm in multiple post-marketing studies that include 7-week treatment cycles, and a steady stream of data is expected by Access through year-end 2009.

On 7/28/09, Cardium Therapeutics (AMEX: CXM) ($1.94) and its subsidiary Tissue Repair Company provided an update on the completion of their MATRIX Phase 2b clinical study and announced plans to provide detailed safety and efficacy data for their Excellarate product candidate around the end of September. The MATRIX trial, a prospective, randomized, double-blind, placebo-controlled study, has enrolled 124 diabetic patients with non-healing, lower extremity neuropathic ulcers.

The companies also reported that results from the MATRIX clinical study are expected to be used to support additional studies and applications of Tissue Repair's Gene Activated Matrix (GAM) technology for ulcers and other potential applications, including not only the repair of soft tissue injuries such as diabetic or pressure ulcers, but hard tissue injuries such as those affecting bone. On 8/25/09, CXM announced that all patients enrolled in the MATRIX clinical study have now completed their initial 12-week evaluation period. On 10/1/09, CXM announced that it expects to receive the locked unblinded data set and be in position to announce preliminary results on or before 10/14/09.

On 5/27/09, Cytori Therapeutics (NASDAQ: CYTX) ($3.50) announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori's Celution System as part of a novel procedure for chronic heart disease. The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10.

On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.

On 9/9/09, Cytori announced its fall medical conference presentation schedule, including the San Antonio Breast Cancer Symposium (December 9-13) presentation of (1) interim, rolling six-month results on patients from the RESTORE-2 study and (2) preclinical data will be presented on the mechanisms by which ADRCs safely enhance fat grafting. Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.

Later this week, data from an investigator-initiated (Dr.