Elite Pharmaceuticals Inc (ELTP)

[Couch]

I agree you can't change the FACTS - LMAO!! - AND here are the FACTS. The FDA has GREEN LIGHTED the path forward with SequestOx - AS I SAID THEY WOULD - FACT.

Elite Provides Update On SequestOx™ New Drug Application
NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the Company met with the U.S. Food and Drug Administration (the "FDA") on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx™. Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter ("CRL"). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.

SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride) 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. The proposed plan submitted by the Company addresses items cited in the CRL dated July 14, 2016 for the New Drug Application (the "NDA") for SequestOx™.

"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."