美国食品药品监督管理局（FDA）在针对Replimune Group Inc.的完全回应函中指出，现有临床数据尚不足以证明其溶瘤病毒疗法vusolimogene oderparepvec具有显著有效性。监管机构认为，当前提交的证据未能达到"实质性有效证明"的审评标准，要求企业补充更多临床数据支持该疗法的疗效结论。
美国食品药品监督管理局（FDA）在针对Replimune Group Inc.的完全回应函中指出，现有临床数据尚不足以证明其溶瘤病毒疗法vusolimogene oderparepvec具有显著有效性。监管机构认为，当前提交的证据未能达到"实质性有效证明"的审评标准，要求企业补充更多临床数据支持该疗法的疗效结论。
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