Grapefruit USA Inc (GPFT)

[Woodberry578]

Dean says your request is a possibility! The key is to frame the video around the information provided in the new 510K submission package. It seems critical to Dean the video SHOULD NOT include anything OUTSIDE of the submitted information as it could end up generating more FDA questions and creating delays in the approval process!

I would assume we would not see this video until after a face-to-face meeting with the FDA has occurred and direction going forward on the resubmittal has been gained.