Grapefruit USA Inc (GPFT)

[IMGGorBust]

As has been discussed here countless times, it's 90 TOTAL days of review time, which includes review time from previous submissions. But even if the agency has already consumed 90 total days, there's a 30-day review cycle that is almost always entirely consumed for each new submission. Since we are in a 2nd or later Additional Information Action request/response cycle, and the FDA consumed more than 90 days total during previous review cycles, the FDA's goal / guideline should have resulted in a response from the FDA within 30 calendar days. The FDA does not consider the additional administrative time of mail/logging the applicant's response into their system/getting a vote from the Board based on the recommendation of the review team/logging their response into their system/mail back in those 30 days. Those functions generally result in approx. 10 additional days. So for our purposes, 40 calendar days is generally the mark.

However, it's just a guideline not a deadline. Applicants have no recourse against the FDA if the FDA fails to meet its guideline. And this would not be the first time the FDA has failed to meet its guideline. I will be the first to admit, I expected to hear from the FDA by this Monday at the latest. I consider the FDA's response to officially be "late" right now. But that and $2 will get me a cup of coffee at Starbucks. I had been encouraged about the FDA's track record in 2010. They seemed to be getting back on track for responding on time and they seemed to have opened the flood gates for approving radiation emitting devices, but alas, they are late. We are again in the position of murmuring, any day now, any day now. This would be an appropriate time, in my opinion, for Dean to contact the FDA proactively and inquire about the status. I hope he does that and reports back to us, but more importantly, I hope we just hear from the FDA "any day now."