GemVax's Phase 3 Clinical Trial Plan for Alzheimer's Treatment Rejected Domestically
[Asia Economy Reporter Minji Lee] GemVax announced on the 22nd that the domestic Phase 3 clinical trial plan for GV1001 targeting patients with moderate to severe Alzheimer's disease has been rejected.
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The rejection was due to insufficient supplementary data regarding the number of trial subjects, the basis for calculation, and the co-primary efficacy evaluation variables, in accordance with Article 25 of the Enforcement Decree of the Act on the Handling of Administrative Complaints. The company stated, "We plan to supplement the missing data and reapply as soon as possible."
This content was produced with the assistance of AI translation services.
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