Samsung Pharmaceutical (KRX:001360) has voluntarily withdrawn its application for a changed Phase 3 clinical trial plan for GV 1001, a treatment for Progressive Supranuclear Palsy-Richardson's Syndrome (PSP-RS).
The application was originally submitted to South Korea's Ministry of Food and Drug Safety (MFDS) on July 1, according to a filing on Wednesday.
The withdrawal follows an MFDS request for supplementary data during the review process, with the company determining it would be more appropriate to prepare a comprehensive response and reapply.
The company stated it plans to supplement the relevant materials promptly and reapply for Investigational New Drug or IND approval.
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