A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.

With shares of Human Genome Sciences (NASDAQ: ) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. 

On 7/20/09, Trinity Biotech (NASDAQ:  ) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. 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 found with the other three competing products.

On 5/29/09, Theratechnologies (TSE:TH) (PINK: ) ($2.00) filed a New Drug Application (NDA) with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is expected to occur in late 1Q10.

On 7/20/09, A.P. Pharma (NASDAQ: ) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron, which is already approved by the Agency.

On 7/14/09, Genta (OTC:  ) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta's recently completed Phase 3 trial of Genasense in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication.

On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe.

On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.

On 6/30/09, AspenBio Pharma (NASDAQ:  ) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.

This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009.