Updated calendar report on 12 Extreme Trades including (AMEX:HEB), (NASDAQ:DSCO), (NASDAQ:BDSI), (OTC:ADLS) and others.
LOS ANGELES - 05/21/09 - Today, in a new special report, BioMedReports.com- the news portal covering the biomedical news and financial sector- has researched and released the details of 12 extreme FDA trades for 11 companies with market caps below $200M- all of 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 covered in the report which features trades for companies including:
Hemispherx Biopharma (AMEX:HEB): Ampligen (Poly I: Poly C12U) NDA 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 (please note this is Memorial Day so the markets will be closed for a long weekend and re-open on Tuesday 5/26).
Arca biopharma (NASDAQ:ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09 (please note this date is a Sunday so Monday 6/1 is the more likely date for an announcement or update on the FDA decision).
Advanced Life Sciences (OTC:ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP) with a PDUFA decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of the FDA is tentatively scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision.
Discovery Labs (NASDAQ:DSCO): DSCO announced that it has received written notice from the FDA that an end-of-review meeting has been scheduled for 6/2/09 to determine the resolution of the remaining primary issue necessary for the Company to gain U.S. marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.
BioDelivery Sciences (NASDAQ:BDSI): Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision by Monday 6/15/09 and a $27M milestone payment if approved from partner Meda AB. Onsolis is a small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the cheek.
The full special report covering more details and profiles for all 11 companies can be found at BioMedReports.com:
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Disclosure: No positions.
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