FDA's request for 12-month endometrial safety data before approving TherapeuticsMD Inc.'s vaginal estradiol candidate TX-004HR surprised the sponsor, which maintains that a May 5, 2017 complete response letter (CRL) for the dyspareunia treatment deviates from the agency's previous position on the data needed for the dyspareunia treatment.
"Throughout the TX-004HR clinical program, we had numerous discussions with the FDA regarding the safety and efficacy design of the trial to support approval," TherapeuticsMD CEO Robert Finizio told a May 8 conference call
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