Announced details
Regenerative medicine products and treatment for amyotrophic lateral sclerosis (ALS)
The Company received a face-to-face consultation from PMDA regarding the clinical trial plan for iGRP.
An incorporated administrative agency responsible for the approval review of pharmaceuticals, medical devices and other products, safety measures, and relief for adverse health effects. The document does not state its location, representative, capital or year of establishment.
Nagoya University
The impact on consolidated results for the current fiscal year is expected to be immaterial.
The company does not address Contract Value / Offering price.
Ministry of Health, Labour and Welfare, “FY2024 Statistical Report on Public Health Administration”
| Item | Details |
|---|---|
| Names of Products / Services Covered | iPS Neural Glial Cells (iGRP) |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An incorporated administrative agency responsible for the approval review of pharmaceuticals, medical devices and other products, safety measures, and relief for adverse health effects. The document does not state its location, representative, capital or year of establishment. |
| Relationship with the Company | The Company received a face-to-face consultation from PMDA regarding the clinical trial plan for iGRP. |
| Launch date | The clinical trial is planned to be conducted at Nagoya University, but the start date is Not disclosed |
| Applicable area | Regenerative medicine products and treatment for amyotrophic lateral sclerosis (ALS) |
| Location | Nagoya University |
| Impact on Business Performance | The impact on consolidated results for the current fiscal year is expected to be immaterial. |
| Source | Ministry of Health, Labour and Welfare, “FY2024 Statistical Report on Public Health Administration” |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Based on the discussions held during the face-to-face consultation with PMDA.