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Intratumoral oncolytic herpes virus G47 for residual or recurrent glioblastoma: a phase 2 trial

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[1] [2] Blood levels of B12 may rise quickly following injection, though elevated blood levels do not immediately translate to symptom resolution

We considered these requests in development of the proposed rule but do not believe it necessary to provide this further information to fulfill CMS' statutory obligation and believe that the potential benefit to manufacturers of additional data are outweighed by the administrative burdens additional reporting would impose to the agency