Elite Pharmaceuticals, Inc. reported the company received official minutes from its December 21, 2016 end-of-review meeting with the U.S. Food and Drug Administration (the “FDA”) for the New Drug Application (the “NDA”) for SequestOx (oxycodone hydrochloride and sequestered naltrexone hydrochloride). The meeting minutes support a plan to address the issues cited by the FDA in the July 14th Complete Response Letter by modifying the SequestOx formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOx application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation. SequestOx is Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.