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SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2016
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

NOTE 16 – SUBSEQUENT EVENTS

 

We submitted the New Drug Application, or NDA, for TX-004HR with the U.S. Food and Drug Administration, or FDA, on July 7, 2016. The NDA submission was supported by the complete TX-004HR clinical program, including positive results of the recently completed phase 3 Rejoice Trial. The NDA submission included all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the REJOICE Trial. Once submitted, the FDA has a 60-day filing review period to determine whether the NDA is sufficiently complete to permit the FDA to accept the NDA for filing.