Investor Presentaiton

Evaluation of Clinical Study of Gene Therapy in Japan Clinical Research Head of the Organization Clinical Trial under the Regulations of Pharmaceutical Law Sponsor I Submission of Protocol Submission of Protocol ¦ Report Report Minister of MHLW Minister of MHLW Judgment of newness Report Consultation Report YES Consultation No Report within one month Health Science Council Guidelines for Gene Therapy Clinical Research Food and Pharmaceutical Affairs Council Guidelines for Assuring the Quality and Safety of Gene Therapy Products Type 1 Use Regulations in Japan ✦

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