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10:52
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Originally posted by Dhm:
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We really were kidding ourselves when we dissed the USA as a primary market when the FDA asked for more justification. We all pretended we didn't need the US and refocused our interest on UK and Europe. But if (when!) the FDA gives us approval as a Class 2a diagnostic tool all will be forgiven. However, considering the US market is so important, why has it taken over 9 months to get to APPLY again. Well I suppose I know the answer, COVID, an inefficient partner in Experion, and complicated questions from the FDA. Lets hope we are ready to deliver winning answers for a fast turnaround.
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Its more likely a case of opportunity cost where the team has been working on applications for SleepCheck, rugged devices, etc and haven't devoted time to FDA.
