Announced details
Ischemic diseases
The Company is engaged in discussions on clinical and CMC matters in preparation for the U.S. BLA submission for the HGF gene therapy product.
The U.S. regulatory authority for food and drugs. Other details, including its location, representative, capital, and year of establishment, are not disclosed.
The Type B Meeting will have no impact on the Company's consolidated financial results.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | HGF gene therapy product |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The U.S. regulatory authority for food and drugs. Other details, including its location, representative, capital, and year of establishment, are not disclosed. |
| Relationship with the Company | The Company is engaged in discussions on clinical and CMC matters in preparation for the U.S. BLA submission for the HGF gene therapy product. |
| Applicable area | Ischemic diseases |
| Impact on Business Performance | The Type B Meeting will have no impact on the Company's consolidated financial results. |
Items this document does not state (12)
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.The FDA agreed to the Company's plan for the CMC (chemistry, manufacturing and controls) section, providing a clear path forward for the CMC-related submission.