FDA, Clinical Trial Extreme Trade Stocks: $BMOD.OB $EPCT $GNBT

Below are some stocks trading at $1 per share or less with pending binary events in the form of expected FDA decisions or clinical trial results that are expected to have a major percentage impact on the underlying share prices and represent high risk / reward, speculative trading opportunities.

On 6/24/10, Biomoda (OTCBB:BMOD) ($0.17, $15 million market cap) completed patient enrollment and sample collection in an ongoing Phase 2 pilot study of CyPath (experimental lab-based diagnostic assay screening test for early-stage lung cancer) with top-line results to follow when available to support a planned pivotal study by year-end 2010 with up to 3500 patients and a projected Pre-Market Approval (PMA) filing with the FDA by year-end 2011 contingent upon pivotal study results.

On 7/20/10, Biomoda announced that it filed a U.S. patent application on a quantitative method for scoring cells labeled with the CyPath assay to determine whether cells are dysplastic or carcinomic by measuring the photon emission rate. The patent filing relates to systematic, measurable system that has the potential for use as a population-based screening tool for both cancer and pre-cancers. The Company also reported that the pilot study was nearing completion at the time of the patent filing announcement in late July.

On 6/29/10, EpiCept (NASDAQ:EPCT) ($0.99, $44 million market cap) announced a New Drug Application (NDA) submission to the FDA for CEPLENE (histamine dihydro-chloride) with a six-month priority review request for the proposed treatment of acute myeloid leukemia (AML) patients in first complete remission. EPCT expects a Health Canada New Drug Submission (NDS) decision for CEPLENE during 4Q10, which is already approved in Europe (marketing partner Meda AB) and is being evaluated in an EU post-approval study with up to 150 patients with data expected in late 2011.

On 7/28/10, Generex Biotechnology (NASDAQ:GNBT) ($0.39, $104 million market cap) announced that 75% of the required number of per-protocol completers in its ongoing six month pivotal global study for Generex Oral-lyn (recombinant human insulin, buccal spray) with an expected early 2011 completion date and a formal interim analysis planned after 90-day results for all subjects to support potential non-inferiority claim to standard injected insulin therapy.

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Disclosure: Long BMOD.OB