Grapefruit USA Inc (GPFT)

[wiseoldowl]

It is my belief that, since Imaging3 received NSE, we will be seeing a new 510(k) filing. This would be the quickest way for approval. An appeal does not seem to be even remotely considered and the De Novo process while it looks good on paper has the probable outcome of turning into a 18 month clinical trial which is obviously not something any of us want. During one of the conference calls, I asked Dean if there had been any improvements to the DViS since submission. He said there had been a number of improvements but if approved it would be as submitted; any improvements would require a new fillings. Since Imaging3 received NSE, these improvements would be allowed when filing a new 510(k).