Elite Pharmaceuticals Inc (ELTP)

[Couch]

Total BS or the FDA would not have given the green light to proceed further.

Elite Reports On SequestOx™ FDA End-Of-Review Meeting
Elite Will Proceed with Studies Required for an NDA Resubmission

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82925&GoTopage=1&Category=2163&BzID=2258&t=2086&G=939

NORTHVALE, N.J., Jan. 23, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today 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 SequestOxTM formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM 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.

"We are very pleased that the meeting discussions with the FDA provide a clear path forward for SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, we plan to initiate the bridging studies immediately and are expecting to resubmit our NDA this year."