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05/28/16 8:29 AM

#202263 RE: whatdoyouseek #202262

I have also posted the $ELTP website Mar 2016 PR.

Elite Announces U.S. FDA Priority Review Designation for SequestOx™ NDA

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=80708&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

Also remember that NH has stated often in the CCs that $ELTP mgmt team have been in close contact with the FDA throughout the past 2 years concerning SequestOx. Whatever the FDA wanted, $ELTP provided with the 163 Person P3 being the final data that the FDA requested.

Nothing remains so that the PDUFA "no-later" than Jul14, 2016 is set in concrete. That is exactly why there is no ADCOM meeting scheduled as NONE is needed. The FDA has already made their decision! Now we wait patiently for the posting date of the expected SequestOx approval.