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 (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 (please note this is Memorial Day so the markets will be closed for a long weekend and re-open on Tuesday 5/26). Click here for a link to a special report on HEB at BioMedReports.com, including a link to an audio interview with the Chairman/CEO of HEB, Dr. William Carter.
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). ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes. Click here for a special report on ABIO, including a related video.
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): On 5/11/09, 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.
Following the meeting and receipt of formal written minutes from the FDA, DSCO plans to provide an update, including the expected timeline for the potential approval of Surfaxin. On 4/17/09, DSCO Discovery Labs received a Complete Response Letter (CRL) from the FDA for Surfaxin. In its letter, the FDA focused primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before Surfaxin can be approved.
The FDA questioned whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether DSCO has adequately validated the BAT and determined its final acceptance criteria.
