Whether explicitly stated or not regarding FDA approval, it's a friggin Medical devide. Who didn't/doesn't know it required/requires FDA approval with a minimum timeline to be determined by FDA? I'd say one would have to be a complete moron not to know such basic facts. Furthermore, the not telling "folks" when raising money is even less informed than the FDA angle being pitched here. Reason being, those who bought the Private Placement are usually folks with lots of cash AND requires a higher level of investment knowledge than the average Joe in Pennyland - in order to participate in the stock offering. So not only would you be claiming folks here are dumb, but the PP holders would be even dumber because they have insider information we do not. Finally, when you say "they are either stupid or deceitful" - I Totally Agree! However, The "they" is only two people I'm aware of - Dumb and Dumber!
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