"Dean was very confident in this last video. Dean has four(4) FDA approvals to his name (while at Toshiba was it?) and seeing his confidence is a good bet we are online for approval."
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I'll give you the benefit of the doubt and assume you haven't been around IMGG for very long and so explain that Dean has been very confident, just as confident, for the past 2 years and particularly the last 6 months. And we're still waiting. The last submittal was just labeling, routing cleanup, followup stuff, dotting I's , crossing T's, etc. The confidence he expressed in Nov/Dec was compelling and inspiring to anyone who believes in him.
Approval has little or nothing to do with how confident Dean is. If it did, he'd have his approval already. It depends on FDA and Dean's ability to devine/satisfy what it is they want. And then the hope that they don't cook up more hoops to jump through. And those are very, very big unknown variables. We place a lot of trust in the fact that he's done several successful submittals before but he himself admits that he's in uncharted waters here with the length of time it's taken; yet while he has brought in outside help before to aide in addressing technological issues he is so far resistant to seeking outside help (for ex., FDA consultants who shepherd apps through to approval for a living) specifically to gain additional expertise in dealing with FDA and getting it done. I'd like to be wrong, but I see of no reason to be any more confident of approval this time around that the last. Not saying it's not going to happen, only that the hurdles, both reasonable and unreasonable, political, bureaucratic and technological are bigger than many appreciate.
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