BioDelivery Sciences International Inc. (NASDAQ: BDSI) is bouncing higher today as investors anticipate FDA approval for its cancer pain drug. In a press release, the company said that it has reached an agreement with the Food & Drug Administration (FDA) and a review team on all aspects of the new drug application (NDA) for ONSOLIS. The regulatory agency informed BDSI that it "will not be issuing a review extension letter, as their action on the NDA is forthcoming."
"Although we cannot pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target," explained Dr. Mark Sirgo, BDSI's president and CEO.