The company has not recorded any revenues for the current as well as previous quarter.

Operating loss for the quarter was $2.32 million, compared with an operating loss of $2.55 million in the previous year period.

Dave Gonyer, R.Ph., president and chief executive officer, stated, “The fourth quarter proved to be very positive for Evoke as we believe we now have a clear path forward with the U.S. Food and Drug Administration (FDA) for submission of a 505(b)(2) New Drug Application (NDA) for Gimoti™ (metoclopramide nasal spray). A comprehensive review of the efficacy data from our Phase 3 trial in women revealed statistically significant benefits in patients with moderate to severe gastroparesis symptoms, which is consistent with FDA’s July 2015 Draft Guidance for the effective clinical evaluation of drugs for the treatment of gastroparesis. These data were discussed with FDA at our December 2016 pre-NDA meeting and agreement was reached that the Company could pursue a comparative exposure pharmacokinetic (PK) trial to demonstrate bioequivalence of Gimoti in healthy volunteers for the planned 505(b)(2) NDA submission. We recently received another favorable response from FDA exempting Gimoti from a Human Factors Validation study. This exemption helps de-risk the path to commercialization, while also freeing up resources that can be directed toward completion of the PK trial and parallel preparation of the NDA.”