The FDA will review any submission the company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.
Michael Flavin, CEO of Advanced Life Sciences, said: “We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal. In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner.”