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关注：1
2013-05-23 12:21
求翻译：VALENCE and PHOTON-1 data were reviewed later in the PDUFA V review cycle as part of SOF’s Breakthrough Therapy designation. Dr. Rodriguez-Torres’ site in Puerto Rico was already inspected as part of this NDA review so we felt we could rely on the data from PHOTON-1. VALENCE was not conducted under IND. The following f是什么意思？ 待解决
 悬赏分：1
- 离问题结束还有
VALENCE and PHOTON-1 data were reviewed later in the PDUFA V review cycle as part of SOF’s Breakthrough Therapy designation. Dr. Rodriguez-Torres’ site in Puerto Rico was already inspected as part of this NDA review so we felt we could rely on the data from PHOTON-1. VALENCE was not conducted under IND. The following f
问题补充： |
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2013-05-23 12:21:38
价态和光子- 1的数据，后来在PDUFA第五节审查周期审阅的SOF的突破性疗法的指定部分。
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2013-05-23 12:23:18
作为SOF的突破疗法指定一部分，化学价和PHOTON-1数据在PDUFA v审查周期以后被回顾了。罗德里格斯博士Torres'站点在波多黎各已经被检查了作为这NDA回顾一部分，因此我们感到我们可能依靠从PHOTON-1的数据。化学价未被举办在IND下。从化学价试验的以下五个临床调查员站点由申请人验核：
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2013-05-23 12:24:58
化学价和PHOTON-1数据在PDUFA v回顾周期以后被回顾了作为SOF的突破疗法指定一部分。 博士。 罗德里格斯Torres’站点在波多里哥已经被检查了作为这NDA回顾一部分，因此我们感到我们可能依靠数据从PHOTON-1。 化学价未被举办在IND之下。 以下五个临床调查员站点从化学价试验由申请人验核：
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2013-05-23 12:26:38
正在翻译，请等待...
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2013-05-23 12:28:18
正在翻译，请等待...
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