Even more useful information from this presentation:
Slide 45 of the video:
"We have this regulation about confidentiality really on the existence of a 510(k) application. We don't make it known publically that we have a 510(k) application under review, and we don't make anything known to the public other than those that we find SE. . . ."
All those clamoring for Dean to release more specifics about the content of the application and the specifics about what the Reviewer is communicating to Imaging3 need to understand that this is a confidential process.
"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."
Now that is a HOOT! Neph never heard a PEEP from the FDA for 15 months and then got a NSE!
Thanks for this post IMGGorBust. After years of waiting, it is difficult get my head around the fact that there is "at least" a 97 percent probability that approval will take place sometime over the next week. WOW.