Entera Bio Ltd. 已向监管机构提交简化版三期临床试验方案,正式启动EB613治疗绝经后骨质疏松症患者的注册项目。公司预计将于2028年下半年获得关键顶线数据,较原计划提前约一年。同时,Entera Bio承诺开展为期12个月的扩展研究,该研究将与潜在的新药申请审评流程同步进行。公司预计将在60天内获得美国食品药品监督管理局的反馈意见。
Entera Bio Ltd. 已向监管机构提交简化版三期临床试验方案,正式启动EB613治疗绝经后骨质疏松症患者的注册项目。公司预计将于2028年下半年获得关键顶线数据,较原计划提前约一年。同时,Entera Bio承诺开展为期12个月的扩展研究,该研究将与潜在的新药申请审评流程同步进行。公司预计将在60天内获得美国食品药品监督管理局的反馈意见。
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