Wednesday, June 14, 2017 9:24:43 AM
TherapeuticsMD is scheduled to meet with the FDA TherapeuticsMD is scheduled to meet with the FDA in a Type A Meeting to discuss the Complete Response Letter the FDA issued regarding the Company's New Drug Application for TX-004HR and a protocol for Phase 4 post-marketing study to gather the 12-month safety data, as prior guidelines and precedents have not required such data prior to approval and would run counter to the 505(b)2 pathway. The meeting is scheduled for June 14.
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