As with previous installments, this article is neither an endorsement of the 16 companies profiled nor a complete list of extreme trades included in the BioMedReports.com FDA Calendar. Related stock indexes for this article include the Regulatory Catalyst Index, the Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index, and the Emerging Diagnostics Index.

Trinity Biotech (NASDAQ:TRIB): On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval. On 3/10/09, TRIB provided the following update on the Company's new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08.

Angiotech Pharma (NASDAQ:ANPI): On 3/9/09, ANPI presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study. ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.

NeuroMetrix (NASDAQ:NURO): Status of pending 510k submissions to the FDA as of NURO's SEC 10Q filing on 5/15/09 includes the following: The ADVANCE NCS/EMG System is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The system was launched during 2Q08 and is used primarily by neurologists, physical medicine & rehabilitation physicians, hand surgeons, and other specialists. NURO submitted a 510(k) application to the FDA on the (1) signal detector in December 2008 and filed an application on the (2) stimulator for the device in April 2009 for marketing clearance of a product designed to precisely deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves for regional anesthesia, pain control, and the treatment of focal neuropathies. The FDA does not issue decision date deadlines for medical device 510(k) submissions.

BSD Medical (NASDAQ:BSDM): On 5/18/09, BSDM announced that the FDA has granted Humanitarian Use Device (HUD) designation for the company's BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device's safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the U.S. per year. Now that FDA has granted the HUD for the BSD-2000, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application.

BSDM believes that data previously submitted to FDA and reviewed by the Agency as part of the Company's pending medical device Pre-market Approval (PMA) submission can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000. Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the Company's strong desire to bring the BSD-2000 to market as quickly as possible, the FDA recommended that BSDM pursue a HDE marketing approval to authorize the commercial sale of the BSD-2000 in the U.S. On 1/7/08, BSDM received a letter from the FDA providing guidance as to amendments needed to make the PMA approvable and the Company responded to this letter on 7/17/08.

Hemispherx Biopharma (AMEX:HEB): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09.