Replies to post #25429 on Grapefruit USA Inc (GPFT)

[ltt05]

Great DD.

[IMGGorBust]

More useful information from this presentation:

"Approximately 3% are found NSE
Data is looked at last in the 510(k) regulatory process"

You can actually watch the presentation delivered as a video (http://fda.yorkmedia.com/fda/Viewer/Viewers/Viewer240TL.aspx?mode=Default&peid=e0ea02ad-4f0c-4532-a98f-a9406caa01d0&pid=1f2b7ad0-cc67-4edc-b0a4-76f3d20014d9&playerType=WM7#). The commentary that accompanies this slide, provides: "Approximately 3% of our 510(k)s have a determination of NSE. Data is the last thing we look at in the 510(k) regulatory review process. We first look at the predicate device, the intended use, and the technology. And if we get through that in the 510(k) regulatory review process, we then look at the data... We have interactive review processes and we want to be in contact with you so you should never get an NSE determination without having heard from us if we're looking at data. Most likely you would hear from us first."

In the case of the DViS 510(k) application the "data" is the Radiologist Review that we know is positive. Dean has said, as recently as the most recent conference call, that he has received no questions, comments or criticisms from the FDA about the Radiologists Review. We also heard from Dean that the Radiologist Review concludes SE or superiority. Gentlemen and ladies, we are in the home stretch. GLTA.