Grapefruit USA Inc (GPFT)

[ltt05]

It comes from the FDAs website and guidelines for decisions on devices.

They aim to reach a decision--be it the need for more information, SE, NSE, or any formal request--on all products submitted with 150 days of submission. In the past two quarters, they have reached a decision on 100% of products within 150 days.

Now, the DViS submission will have been in the FDA's hands for 150 days on/around September 8th without any formal requests or decisions.