Grapefruit USA Inc (GPFT)

[IMGGorBust]

I think it is very likely that the FDA considers itself to be in the 75 Day (Response to the 1st Information Action Request) or the 90 Day (1st Submission) review cycle because of the transition of the review team and the head of the CDRH. That may well have started everything over.

Imaging3 did not hold anything back from investors. They submitted exactly what they said they submitted. However, the FDA may be treating it as an initial submission (90 day review period), because it's the first submission that was made to the new review team, or they may be treating it as a submission in response to the first additional information action (75 day review period), because it was submitted in response to their first set of questions / requests. Either way, 90-days is the outside mark for the FDA's INTERNAL GUIDELINES / GOALS. Remember, and this is something that my 5 year old nephew understands but many here seem not to be able to grasp, these review cycles ARE NOT DEADLINES. They are just goals, and if the FDA misses these goals, which they do 10% of the time, there is no recourse for the applicant. It's nice to have a day circled on your calendar because it helps you stay sane through this agonizing process, but it is what it is... a goal, not a deadline.