Grapefruit USA Inc (GPFT)

[IMGGorBust]

Since we are in the Fast Track Program, that communication should not re-start the 30 day review cycle. The whole purpose of the Fast Track Program is that it allows for informal communications and requests from the FDA without restarting the clock. That being said, I'm sure it will justify in the reviewers' minds taking a little extra time. In my opinion though, the FDA's response is not late according to their own internal guidelines.