Stotes - I fully understand that the Stage 3 scans will be undertaken concurrently with the FDA discussions but this in no way implies that the timetable for the discussions has a fixed commencement and a fixed end time that both the Stage 2 and Stage 3 outcomes can be slotted into.
My point is that the timetable for the discussions will, logically, expand or contract according to the timing of Emvision's Stage 1, 2 and 3 scan programs.
The only way that Stage 3 will not extend the discussion timetable with FDA is if the FDA and Emvision come to an agreement on the design of the validation trial - based on just the outcomes of Stages 1 and 2 and before Stage 3 is completed.
While that is possible, my gut feeling is that Scott and the team believe they need more data on the 'bleed' patients to make a watertight case to FDA regarding the sufficiency of their validation phase design. This data will inevitably take more time to collect and analyse, thereby extending the timeline for both Emvision and the FDA.
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