The issue is they had not lodged, therefore they cannot launch a medical device in the US, all they can do is "show" it under strict conditions, eg NDA.
That is completely different to demonstrating a pathway to profitability which Ivan Kelly did. He is far more believable than Miller who has a very nasty habit of talking things up but ommiting key details. Its not a one off, he has form. He lies by omission. All he had to say is we will be making a submission (offer a potential expected time window) and state they will be showing it to potential clients at the CES. That is it, no one would of seen that as a problem, instead he jumbled the communication where even IR didnt know whether anything was lodged and was stating that it will launch at the CES.
In regards to body language, unless you are in the same room, trying to read body language over a zoom call is very problematic
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