Announced details
Patients with acute spinal cord injury
Phase III clinical trial completed. Additional trial not yet started.
The parties conduct face-to-face consultations and discussions regarding the additional clinical trial plan. Capital and personnel relationships: Not disclosed.
An independent administrative agency that conducts regulatory reviews of pharmaceuticals and medical devices. Other details: Not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Miyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634; Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Society of Paraplegia 13:48-49; Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972
| Item | Details |
|---|---|
| Names of Products / Services Covered | Orempermin alfa (development code: KP-100IT) |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An independent administrative agency that conducts regulatory reviews of pharmaceuticals and medical devices. Other details: Not disclosed. |
| Relationship with the Company | The parties conduct face-to-face consultations and discussions regarding the additional clinical trial plan. Capital and personnel relationships: Not disclosed. |
| Launch date | Preparations are under way for an early start of the additional trial. The specific start date: Not disclosed. |
| Applicable area | Patients with acute spinal cord injury |
| Usage history | Phase III clinical trial completed. Additional trial not yet started. |
| Source | Miyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634; Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Society of Paraplegia 13:48-49; Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972 |
Items this document does not state (10)
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.Agreement was reached with PMDA on the outline of the additional clinical trial plan.