Grapefruit USA Inc (GPFT)

[IMGGorBust]

Your problem is in the second sentence. You refer to it is a "deadline," but every time this is discussed by Dean, by Mike, and by posters who have analyzed the FDA's website they have all said it is a guideline/goal not a deadline. After the first 90 cumulative days are consumed, it is literally "any day now" and there is no way to predict what will happen.

The FDA has set a goal for itself, that it claims to meet 90% of the time, that if you are in a second or later additional informatino action request, which we are, and if the 90 cumulative days of review team across all previous submissions has already been consumed, which it has, they aspire to respond with a final decision on Substantial Equivalence within 60 days. However, in Dean's experience, each of the previous 4 successful 510(k) applications he has filed, the final pass, after the 90 cumulative days was consumed on previous submissions, and upon receipt of the final submission, the FDA has responded each time at the end of 30 days of silence with a favorable decision. The 30 days was based on Dean's experience. The 60 days is based on the FDA's goal/guideline. But I will re-state it again for you, it is just a goal. A goal that they meet 90% of the time, but it is just a goal, NOT A DEADLINE. There is no recourse if they miss that goal. If they miss it this time, it wouldn't be the first, and it won't be the last. But it is at least something to hang our hats on.