Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades.

BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.

Discovery Labs (DSCO) has a 4/17/09 PDUFA decision date for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded to the mid-dollar range as the decision date nears and insiders have purchased over 338,000 shares of stock in the past six months.

GTC Biotherapeutics (GTCB) – A decision is expected by 2/7/09 for the Atryn (recombinant human antithrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising ever since.

Hemispherx Biopharma (HEB) – A decision is expected by 2/25/08 for the Company's resubmission of its Ampligen NDA, which is designated as an Orphan Drug for the treatment of chronic fatigue syndrome, which has no FDA approved treatments on the market.