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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Date:11/8/2012

cosmetic issues noted by FDA with the product that required a reformulation effort by BDSI.  Such reformulation work has been completed and these results were submitted in October along with a formal meeting request to FDA.  In this meeting, which has been granted for mid-December, we plan to review this material with FDA and determine next steps.

Anticipated 2012/13 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

  • Submission of BNX NDA for opioid dependence.  Based on the positive outcome of its pivotal PK study, BDSI anticipates it will submit an NDA to the FDA for BNX during the latter part of the second quarter of 2013.
  • Recruitment of two Phase 3 studies for BEMA Buprenorphine.  BDSI and Endo expect to continue recruitment in two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups. The opioid experienced trial is expected to be completed with data read out before the end of 2013 and the opioid naive trial by early 2014.
  • BNX Commercialization Opportunities.  BDSI will continue its exploration of commercialization opportunities for BNX, which include ongoing licensing discussions both in the U.S. and abroad.
  • Re-launch of ONSOLIS in the U.S.  This will be dependent upon FDA's review of the new data submitted to them recently on the reformulation and the outcome of the mid-December meeting with them.
  • Exploration of Potential New Products and Technologies.  In addition to supporting its marketed product and advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals.  Furthermore, BDSI has been investigating potential new products or technologies to complement and div
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SOURCE BioDelivery Sciences International, Inc.
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