For information, the company have announced that trial BR.31 did not meet its primary endpoint in and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time.
Therefore, NICE has decided to suspend this appraisal from its current work programme.
As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.
| Status | Suspended |
| Technology type | Medicine |
| Decision | Selected |
| Reason for decision | Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources |
| Further information | Appraisal in progress |
| Process | STA Standard |
| ID number | 1263 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 13 August 2024 | Suspended. For information, the company have announced that trial BR.31 did not meet its primary endpoint in and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes. |
| 28 June 2024 | Awaiting development. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early June 2025 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early August 2025. |
| 24 July 2023 | In progress. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid-January 2025 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-March 2025. |
For further information on our processes and methods, please see our CHTE processes and methods manual