Dean should have looking at international approvals while waiting on the FDA. The US is typically dead last to approve any new device. At the very least, he should be looking at Canada and maybe the EU.
Filing an appeal is the end of the road for IMGG. The FDA will never reverse their decision. It will only give Dean Janes the ability to continue hiding the truth. The 510-K was a mistake but maybe a pre-calculated one. Without a working unit Dean Janes managed to collect $4M from his loyal investors without even having to show them the real deal. Imagine what his income plans are going to be if he knows that IMGG is a year or two from bankruptcy.
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