BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company recently 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 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.

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 voted that Atryn is safe + effective and recommended it for approval at a meeting last week.

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. Ampligen is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a "promising" designation by the Agency on Health Research Quality (AHRQ): "Ampligen, an investigational drug that is not approved by the FDA, given intravenously to severely debilitated patients, yielded the most promising results."

Northfield Labs (NFLD) – The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09. Around the same time late last year, Biopure (BPUR) received a clinical hold notice from the FDA, which blocks future clinical trials of its blood substitute candidate Hemopure.