Grapefruit USA Inc (GPFT)

[TMG49]

I recieved a lengthy email from Mike Nessen yesterday in response to some questions I sent to him a few weeks ago. In the email, he did explicitly mention that they have been placed on the "fast track" by the FDA. He also explained that the 30 day turn around does not include "administrative" days which typically add an additional 5 days to both the front and back end of the submission. Currently the Imaging 3 team expects a response from the FDA by mid May, according to Mike. He did, of course, mention that nothing is for certain and couldn't guaranty anything.

He also mentioned that they are very happy with the new review team. They have been much more responsive than the previous reviewer. 17 of the 18 questions that were initially asked were answered over the phone by Dean. The last question, of course, was the radiologist review of the Dominion. Mike also wrote that he thought the FDA was anxious to get this approval behind them as, "We’ve been on the docket far too long and we can make a compelling case that most of the reasons for that lie at the feet of the FDA"

Imaging 3 remains very optimistic that approval will be granted this time around.