Replies to post #27387 on Grapefruit USA Inc (GPFT)

[mr_sano]

I just think its a grey area. No basis other than the amount time of submittal and resubmittal

If they say its NSE then its material as FDA approval is NOT comming via the 510K process. If FDA comes back with AI its not a no..therefore its still under review although the clock is stopped until the information requested is submitted. I'm sure every Lawyer here will say Dean has to report this...but I would not be surprized if there is more communication between Dean and the FDA then we are aware of.