The accompanying table presents an updated calendar of expected FDA decision dates and advisory committee [FDAC] meetings expected to impact the price of underlying biotech and pharma stocks. Genzyme (GENZ) faces a FDAC tomorrow (10/21) for its pending BLA for Myozyme manufactured at the 2,000L bioreactor scale. Also, Discovery Labs (DSCO) submitted its complete response to the FDA last Friday to address an approvable ruling for Surfaxin back in May and insiders continue to buy the stock. DSCO expects the FDA to rule on Surfaxin as a Class I review (60-day) rather than the longer Class II period of six months with an official response due by the agency on 10/31/08. Finally, Cypress Bio (CYPB) and Forest Labs (FRX) announced that the FDA would delay its decision on milnacipran as a treatment for fibromyalgia, but the agency stated the matter should be resolved in "a matter of weeks" -- implying there are no major deficiencies in the application.
$66.33 (10/21/08)
