Replies to post #31089 on Grapefruit USA Inc (GPFT)

[Ryoko]

I'm thinking that Dean was in over his head with the 510K on this. I know there were claims that he had experience in doing FDA filings in the past, but I wonder if that experience was a bit exaggerated. Sloppy and/or incomplete filings would go a long ways to explain the string of setbacks and delays with the FDA.

I'm looking forward to seeing IMGG bring in some outside help with a proven track record to get the 510K sorted out and refiled. At least we'd be able to eliminate problems with the 510K paperwork as one of the reasons for not receiving clearance.

I would also like to see a demo of the unit at RSNA.