@AaronS76 As has been discussed here before, FDA EUA is probably achieved via a process as opposed to a single submission; that is, Nanodx have likely been liaising with FDA to satisfy requirements for EUA over a period of time. In the presentation, our management said Nanodx are to provide FDA with data "shortly" for EUA - seems promising especially when you consider Nanodx comms and activity on social media lately. Nanodx already know what the data says and are confident of approval IMO.
It also suggests they have resolved all design issues given data collection is nearing completion. They would not have been collecting data if the design was still being updated IMO
