"The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013), of approximately 700 subjects in each study. The two studies may enroll subjects simultaneously. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy.
The Company is now engaged in activities necessary for beginning the Phase 3 study. Manufacturing of Brilacidin has been completed and is presently undergoing quality control and stability testing."