You got a reply from IR! So it is the case that they have not yet applied for Gen 4 OTC qualification by the FDA. This explains why they could not launch it at CES as being for that OTC purpose. If it was showcased at CES as not for OTC with no application pending, there would have been no regulatory restrictions. Gen 4 It still could have been "launched" without claiming any proposed OTC connection at this stage but the OTC market is the target hence its importance in any launch. Why couldn't they simply explain this to shareholders instead of creating such uncertainty by going silent on the subject?
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