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ProKidney股价飙升,FDA确认加速批准途径
这家处于临床后期的细胞治疗公司透露,FDA同意其正在进行的PROACT 1三期临床试验中的估计肾小球滤过率(eGFR)斜率可作为加速批准途径下生物制品许可申请提交的替代终点。FDA指出,rilparencel相比安慰剂对照组至少需达到1.5 ...
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