Enliven Treateutics宣布,已就关键III期临床试验Enable-2的研究方案与美国食品药品监督管理局达成重要共识。双方确认了80毫克每日一次作为试验剂量,并明确了试验将针对既往接受过至少二线治疗的特定患者人群。这一进展为后续临床开发路径奠定了监管基础。
Enliven Treateutics宣布,已就关键III期临床试验Enable-2的研究方案与美国食品药品监督管理局达成重要共识。双方确认了80毫克每日一次作为试验剂量,并明确了试验将针对既往接受过至少二线治疗的特定患者人群。这一进展为后续临床开发路径奠定了监管基础。
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