Wish I was joking with you guys. Can't link it because it's through my EquityFeed platform, but here is the full text.
FDA Issues Complete Response Letter for SequestOx New Drug Application GlobeNewswire "Press Releases"
NORTHVALE, N.J. , July 15, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the Company") (OTCBB:ELTP) today announced that the U.S. Food and Drug Administration (the FDA) has issued a Complete Response Letter (the CRL) regarding the New Drug Application (the NDA) for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride), Elites investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form. CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form.
We are evaluating the CRL received and hope to meet as soon as possible with the FDA to discuss how to address their concerns. We will work closely with the FDA to determine the appropriate next steps and path forward for the NDA, said Nasrat Hakim , President and CEO of Elite.
After the Company has met with the FDA and the Agency is able to provide greater clarity to the issues raised in the CRL, Elite will host a conference call to discuss the pathway forward for SequestOx.
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