Nocturnal Scratch Mission Updates

 
Background
 
 
The Nocturnal Scratch initiative has progressed through multiple phases — from the initial DIME project, to EMA pilot work, to Decode. Each stage has helped to refine measurement approaches and lay the groundwork for broader adoption.
 
 
Current Focus
 
 
Originally, the next step was envisioned as clinical validation. However, recent discussions have clarified that the immediate focus should shift toward regulatory qualification, provided our pharma member agrees this is the right path forward. While regulatory acceptance remains the ultimate goal, qualification offers a more streamlined route, particularly with the EMA.
 
 
Key Points from Recent Discussion
 
 

• Pharma’s Role: Our pharma member remains the central enabler of the mission. Their agreement on direction and scope is critical before any updates are finalized or shared externally.

• Scope & Ambition: The team must align with pharma's on how far the qualification effort will extend, and clearly scope the ambition of this phase.

 
 
 
Mission Status
 
 

• The clinical validation mission is no longer promoted as the current milestone, as key objectives have already been achieved.

• The team is now repositioning the mission as in progress toward regulatory qualification.

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