n (%) 19 0 1(5.3) 18(94.7) 0 1 (5.3[0.1, 26.0]) (Partially modified from Table 24 in the Review Report) https://www.pmda.go.jp/files/000242808.pdf Table Results of additional analysis of tumor response (Principal investigator's assessment, full analysis set, data cut-off on December 31, 2018) Best overall response Complete response Partial response Stable Progression Response (complete response + partial response) (Response rate [95%CI]) 25 < Impact on RS, expectations > the following information to the world: We believe that this article will contribute to the dissemination of regulations for regulatory approvals in Japan by providing The outline of products that have been developed and approved for marketing in Japan ahead of other countries Introduction of various systems / regulations applied to this drug ((1) Designation of orphan regenerative medical products, (2) SAKIGAKE Designation review, (3) Cartagena Act, (4) Conditional and time-limited approval)
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