BioDelivery Sciences International Inc. (Nasdaq:BDSI) announced Monday that its June 28 pre-NDA meeting with the U.S. Food and Drug Administration regarding the company’s Phase III BEMA Fentanyl product went according to plan. Based on the discussion with the FDA at the meeting, BDSI continues to project a New Drug Application submission for the cancer pain product during the third quarter.

The meeting was held to review the company’s questions regarding the format and content of the proposed NDA and the FDA’s responses in an effort to avoid any potential delays to the NDA submission and the FDA review process. According to the company, the meeting was productive, and the FDA’s response was generally in line with the company’s expectations.

As a result, the company believes that the path for NDA submission and acceptance is clear according to the FDA’s requirements. Within 60 days of submitting the NDA, the FDA will determine whether the application is sufficient for review. If the NDA is accepted for filing, the FDA is expected to take up to eight additional months to render a decision on the approvability of the product.

“The meeting met our expectations for what we hoped would be a positive session with the FDA. It was productive and informative and provided us with the type of clarity on key areas of the NDA to assure the application meets the Agency’s needs,” Andrew Finn, BDSI’s executive vice president of product development, said in a statement.

“We will be using the next few months to continue the compilation of the various components for the NDA as we look toward a third-quarter filing,” BDSI President and Chief Executive Mark Sirgo said in the statement. “From our perspective, everything remains on schedule, and we will do everything within our means to make sure we are satisfying FDA requirements. We will be working diligently over the next few months as we compile and submit the NDA and continue our partnering discussions regarding the distribution rights for BEMA Fentanyl in the U.S.”