Announced details
Adenovirus infections after hematopoietic stem cell transplantation
The relationship concerns receiving face-to-face advice on conditional early marketing authorisation for BCV. SymBio Pharmaceuticals obtained a global licence for BCV in September 2019.
An agency under the UK's Department of Health and Social Care. The executive body responsible for the authorisation and safety of medicines and medical devices. The text states that its location is the MHRA office in London.
London (MHRA office)
No impact on the consolidated earnings outlook for the fiscal year ending December 2026
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Brincidofovir (BCV) |
| Counterparty | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Counterparty overview | An agency under the UK's Department of Health and Social Care. The executive body responsible for the authorisation and safety of medicines and medical devices. The text states that its location is the MHRA office in London. |
| Relationship with the Company | The relationship concerns receiving face-to-face advice on conditional early marketing authorisation for BCV. SymBio Pharmaceuticals obtained a global licence for BCV in September 2019. |
| Applicable area | Adenovirus infections after hematopoietic stem cell transplantation |
| Location | London (MHRA office) |
| Impact on Business Performance | No impact on the consolidated earnings outlook for the fiscal year ending December 2026 |
Items this document does not state (11)
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.To receive face-to-face advice from the MHRA on conditional early marketing authorisation for BCV based on existing data. The company aims to make BCV available to patients at an early stage by using the ongoing Phase III trial as a post-approval confirmatory study.