MORRISVILLE, N.C.--(BUSINESS WIRE)--Sept. 20, 2006--BioDelivery Sciences International, Inc. (NASDAQ:BDSI) announced that, in light of, among other considerations, information gathered at a meeting with the FDA last week regarding the company’s Phase III BEMA(TM) Fentanyl product, the company is anticipating the submission of a New Drug Application (NDA) with the FDA on BEMA(TM) Fentanyl during the second quarter of 2007. The meeting with FDA was initiated by the company in advance of an anticipated “pre-NDA” meeting expected early next year so that the company could solicit guidance on key matters regarding the NDA program for BEMA(TM) Fentanyl at this time.
