Risk of changes to regulations governing regenerative medicine
First written in FY2024. 1 of 2 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「If changes are made to the conditional and time-limited approval system under the PMD Act on which the Company strategically relies, including longer review periods, an increase in the number of required clinical trials, or the addition or revision of review requirements, the Company may be forced to make major changes to the timing of product commercialization or its clinical development plan, or may be unable to obtain approval on the terms it anticipated.」
The risk remains that changes to the conditional and time-limited approval system or the drug pricing system could affect the commercialization schedule, development plans and revenue outlook. - FY2024First statedAnnual report
「If changes are made to the conditional and time-limited approval system under the PMD Act on which the Company strategically relies, such as longer review periods or an increase in the number of required clinical trials, resulting in major changes to the timing of product commercialization or the clinical development required for commercialization.」
Changes to the PMD Act or the drug pricing system could affect the commercialization schedule, development costs and product value.