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February 21, 2013
07:16 EDTRPRXRepros Therapeutics reports FDA recommends study of Androxal to be completed
Repros Therapeutics provided a clinical update of its Androxal Phase 3 program following receipt of written guidance from the FDA. The FDA has informed Repros to proceed with the analysis of ZA-301 as previously planned, and that data should be evaluated both with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study. Additionally, the FDA accepted Repros' plan regarding study ZA-302 to enroll additional patients. They also noted that Repros should revise the statistical analysis plan and sample size to reflect increased enrollment. Study ZA-302 will also be analyzed with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study.
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December 4, 2014
08:44 EDTRPRXRepros Therapeutics management to meet with Brean Capital
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