Replies to post #8278 on Grapefruit USA Inc (GPFT)

[dan1drew2]

Admiral - this is only my opinion based on what I have surmised from the many posts I have read about the timing of approval. Round trip of an initial filing is 90 days for the FDA to respond. If after 20 days the FDA responds with an AI (additional information) request than the clock starts ticking again with the balance of 70 days to go. It is however a 60 day time clock for the FDA to respond to an AI once they receive it. Again this is only what I have observed from the various postings I have read. Mike Nessen acknowledged that the receipt of the last submission by the FDA was on the 17th of November. This would bring us to lets say on or about January 17th. Take into consideration the holiday's since the RSNA and it could be extended a bit. Please read post #8228 (The last paragraph) it might clear it up a bit. See ya in the Winner Circle.

[kinlaw]

Actually, if you are that confused and not sure who to believe then you might want to take a look at the FDA site yourself and try to figure out the process.

90 days is the typical "review period" of a 510K process. These 90 days are only counted while the FDA is reviewing the app. The 90 day review clock stops once the FDA responds for more information and starts again once they have received it and has notified the company of the receipt of the info. For additional information, as in the 2nd or more additional information request from the FDA, a 60 day review is needed by the FDA. We are now getting into that 60 day window from the last submission.

[IMGGorBust]

Wow. The possibility of having to wait until the end of December (less than 3 weeks from now) causes you despair? Remember all of these dates thrown out there are based on FDA guidelines, not regulations. I would say Tuesday the 12th is really the earliest anyone should have ever expected, and I would expect to hear from the FDA any time between the 12th and the 19th.