Grapefruit USA Inc (GPFT)

[IMGGorBust]

This response was deleted earlier for some personal remarks that I have now removed. Here's my explanation for why I think the PDF request means we are finished:

You have to look at the full context of the request by the FDA for the PDF electronic copy of the application to reach the most likely conclusion. First, the request for the PDF copy of the DViS 510(k) application was made at the same time that the FDA asked for 2 minor changes to the language in the DViS manual. We know they were minor because they were made by telephone and related only to language changes. The FDA's website explains that only the most minor requests, such as language changes to a label (the actual example given by the FDA), may be made by telephone. Second, we have also heard that since the time of the request for the PDF copy, Dean has contacted the FDA multiple times and each time has been told by the FDA that they have everything they need and they are just running everything through their process. Finally, it's not just that the FDA asked for AN ELECTRONIC COPY... THEY ALREADY HAD AN ELECTRONIC COPY. Dean said the submissions are made by hard copy and electronic copy. The late April request from the FDA was not for AN ELECTRONIC COPY, it was specifically for a PDF electronic copy, to supplement the already provided CD version of the application... a version that could be shared with other government or third party entities for simultaneous review, redlined, edited, supplemented, cut and pasted, etc. Instead, they asked for a PDF version... a version that could not be edited, could not be cut and pasted to other entities for simultaneous review, a version that could be loaded onto the FDA's website and remain unchanged forever. It is also my understanding that the PDF version that was provided was a hand scanned, non-OCR text version. In other words, a "locked" PDF version.

So, if you look at the whole picture, and the language from the FDA's website, that's why I reached the conclusion that I reached that the PDF request means we're done, and as soon as our file gets back to the top of the queue, we will get the good news.