Grapefruit USA Inc (GPFT)

[ElHefe]

Possibly. Maybe Gold can give us his opinion regarding the concern you voice. I was only making the point that the hardware end of this being "off the shelf" is not the only, or even main, area of interest for FDA.

Ultimately, it would seem this discussion topic is all moot now anyway. Judging from what FDA is now interested in based on their last interrogatory (intended use, labeling), it would appear that they are now satisfied with function/performance/safety/efficacy, etc. of the device. Those on this board who uncovered the fact that intended use/labeling should have come after approval discovered more than they know. Can we bemoan the fact that it's taken so long? Yep. Is it going to matter to me one iota when this company gets sold? Nope.