The U.S. Food and Drug Administration (FDA) stated in a complete response letter regarding Replimune Group Inc. that the current clinical data is insufficient to demonstrate significant efficacy of its oncolytic virus therapy, vusolimogene oderparepvec.

The U.S. Food and Drug Administration (FDA) stated in a complete response letter regarding Replimune Group Inc. that the current clinical data is insufficient to demonstrate significant efficacy of its oncolytic virus therapy, vusolimogene oderparepvec.

老虎证券2026/04/10 15:44

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Regulators believe that the currently submitted evidence does not meet the review standard of "substantial and effective proof," and require companies to provide additional clinical data to support the efficacy conclusions of this therapy.

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The U.S. Food and Drug Administration (FDA) stated in a complete response letter regarding Replimune Group Inc. that the current clinical data is insufficient to demonstrate significant efficacy of its oncolytic virus therapy, vusolimogene oderparepvec.

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