Posted On: 10/08/2015 9:08:22 AM
Post# of 72447
Hey Flash,
From the 10-K:
"The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013). 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. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. The Company is currently evaluating potential Contract Research Organizations (CROs) and clinical sites for the global Phase 3 program."
From the 10-K:
"The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013). 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. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. The Company is currently evaluating potential Contract Research Organizations (CROs) and clinical sites for the global Phase 3 program."
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