迪梅里克斯证实ACTION3试验仍在进行,
Dimerix confirms ACTION3 trial remains powered for FSGS drug approval.
迪美力斯有限公司证实其ACTION3第三期试验仍然具有很高的功率,以检测治疗对蛋白尿症的影响,这是主要终点.
Dimerix Limited has confirmed its ACTION3 Phase 3 trial remains highly powered to detect a treatment effect on proteinuria, the primary endpoint.
美国食品和药物管理局已经批准该措施,以全面批准其FSGS药物DMX-200,并且公司将继续进行试验直到完成没有临时分析.
The FDA has approved this measure for full approval of its FSGS drug DMX-200, and the company will continue the trial to completion without an interim analysis.
随着成年人注册完成,儿童医疗招生正在进行中,该试验旨在确保对成人和青少年的批准.
With adult enrollment finished and pediatric enrollment ongoing, the trial aims to secure approval for adults and adolescents.