Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  

Genzyme [GENZ: 58.37, -0.29 (-0.49%)]: On 5/21/09, GENZ announced that it has submitted the final documentation to address all items in the FDA’s complete response letter from 3/2/09 (CRL) for Lumizyme (alglucosidase alfa), which is produced at the 2,000 L bioreactor

Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. 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.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: 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

Sunwin International Neutraceuticals, Inc. (SUWN.OB), the $20+ million Chinese natural medicine and herb producer, reported Friday a Q1 (fiscal 2009) revenue increase of 48%, to $6.2 million.

Sunwin’s herbal and medicinal products are largely blended with other products at the wholesale level, and marketed in China and Japan. Sunwin produces over 120 Chinese herbs, along with a variety of natural additives for animal feed. Perhaps their biggest potential market, however, is in the natural sweetener Stevia (Stevioside), produced from the leaves of the Stevia Rebaudiana plant, a bushy member of the Chrysanthemum family. The plant was successfully introduced to China from South America in the 1970s. Stevioside is estimated to be 200-300 times sweeter than general sucrose, while having only 1/300th the calories.

Stevioside has a long history as a food additive in Asia, with no significant health questions like those that have plagued aspartame and other commonly used non-sugar sweeteners.

China Sky Medical (CSKI) is a maker and distributor of over-the-counter nutritional supplements and herb-based pharmaceutical and medicinal products, primarily in China. The company’s products fall into the genre of Traditional Chinese Medicine (TCM), a medical science that has been practiced in China for 5,000 years and is still wildly popular today. China’s multi-billion dollar pharmaceutical market is predicted to grow at a double-digit rate over the next several years and TCM is expected to have a 20-percent share of the burgeoning market.

China Sky Medical’s products include the sumei slim patch to foster weight loss and prevent weight gain; a pain killer patch used for the treatment of various ailments, including fever, headache, dysentery, diarrhea, and stiffness and pain in the neck caused by hypertension; and the anti-hypertension patch that improves circulation and reduces blood pressure. The China-based company also sells eye drops, dandruff shampoo, a kidney disease