You do realize the difference between product packaging/human factors and data used for validation right? The optimism here is incredible.
Data issues could mean collecting new sets, further analysis, resubmission, etc. This approval is now months out.
So far every swing at the fda has been a miss.
dyor
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- Ann: US FDA advises further data needed for MEBsleep approval
Ann: US FDA advises further data needed for MEBsleep approval, page-8
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