For information, the company have announced that trial did not meet its primary endpoint 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:
- Prioritised
- Process:
- STA Standard
- ID number:
- 3894
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 02 March 2026 | Suspended. For information, the company have announced that trial did not meet its primary endpoint 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. |
| 20 November 2025 | Awaiting development. Following on from information received from the company, the timelines for this appraisal are to be confirmed whilst the company confirm their regulatory filing plans. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes. |
| 30 September 2025 | 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 early September 2026 when we will write to you about how you can get involved. |
| 23 January 2025 | Note - Note added to the project documents |
| 24 March 2021 | Note added to the project documents |
For further information on our processes and methods, please see our CHTE processes and methods manual