In early 2024, EMV have scheduled discussions with the FDA, and during the same period, they will also be conducting additional scans on more individuals.
Following the alignment of their objectives with the FDA, the validation stage will commence, involving further scans. These additional scans will contribute to the comprehensive submission intended to be provided to the FDA.
It's important to note that FDA discussions before the validation stage have always been an integral part of the plan. While engaged in these discussions, it makes sense to simultaneously gather more valuable bleed data. Regardless, EMV has accounted for this FDA engagement prior to the validation stage in their timelines, so conducting additional scans concurrently should not impact the overall timeline as they've indicated.
In early 2024, EMV have scheduled discussions with the FDA, and...
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