The accompanying table includes a calendar of expected FDA decision dates through the end of January 2009, including nine decisions due by the end of September. Some likely near-term movers on the calendar include Cypress Bioscience (CYPB) + partner Forest Labs (FRX) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end. Also, Discovery Labs (DSCO) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvable letter for Surfaxin by the end of September and expects a Class I review by the agency with a potential decision in just two months. Another company not listed on the calendar is BioDelivery Sciences (BDSI), which expects approval for Onsolis (BEMA fentanyl) during the first half of 2009 after making modifications to the risk management program it previously submitted as required by the FDA for approval of the high-potency opioid pain medication.
$85.8 (09/21/08)
