Risk of failure to obtain full approval or cancellation after conditional and time-limited approval
First written in FY2025. 1 of 2 entries say "Restated". Latest entry: 2026-03-27.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- 2026-03-27RestatedManagement Planning
「There is a possibility that full approval may not be obtained, or that conditional and time-limited approval may be revoked, among other possibilities.」
The Company reiterated the risks relating to full approval and revocation after obtaining conditional and time-limited approval. - FY2025First statedAnnual report
「If the efficacy or safety of the Company's products is insufficient, unexpected adverse effects occur, differences arise between the Company and the authorities regarding the results of investigations, or the required number of cases or approval requirements cannot be met, there is a possibility that full approval may not be obtained or that conditional and time-limited approval may be revoked.」
The Company newly identifies the possibility that, in post-marketing studies after conditional and time-limited approval, insufficient efficacy or safety or failure to meet approval requirements could prevent full approval or result in revocation of the conditional and time-limited approval.