For information, the company have announced that their 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 Selected
Process STA Standard
ID number 3906

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Timeline

Key events during the development of the guidance:

Date Update
27 February 2024 Suspended. For information, the company have announced that their 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.
12 January 2024 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 October 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late December 2024.
01 December 2023 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 October 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late December 2024.
17 July 2023 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 July 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-September 2024.

For further information on our processes and methods, please see our CHTE processes and methods manual