Status Awaiting development
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
Process STA Standard
ID number 6278

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Timeline

Key events during the development of the guidance:

Date Update
09 October 2024 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.
05 September 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 2025 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early December 2025.
02 November 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 mid-July 2025 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-September 2025.
02 May 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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