you do agree we did NOT have a fully functioning machine 2+ years ago when this started correct??
I do not agree at all. I believe we had a fully functioning device when Dean applied for and received a patent on the Dominion. I believe there have been significant improvements in the device, just as there is with all cutting edge technology (see the huge leaps from year to year with the iPhone). Kimble, you have to understand that applicants do not include theoretical data in an FDA 510(k) application. The application includes actual hard data; e.g., results of vibration analysis, lists of materials of construction and the proper parameters in which they can operate, comparative analysis of actual radiation tests, etc. These pieces of the 510(k) application could not have been completed if the device was theoretical or didn't actually work. Likewise, Dean couldn't get a patent if the device didn't work. Now, I believe the device today can run circles around the device 3 years ago, just as the device 3 years ago could run circles around competitor devices then and now. It is just not true that at any point in this process Dean did not have a device that could generate real time 3D images. Today it's more efficient, higher resolution, sleeker and can do even more than before, but it could always do what he advertises it can do.
you do agree that we have just recently (within the last six months) obtained a fully functioning machine
See above. We have always had a fully functioning machine.
you do agree that the investors where misled 2+ years ago into thinking they had a fully functioning machine
Absolutely not. See above.
you do agree that hiring an FDA consultant would have been a the correct move 2 years ago
I honestly don't see how that would have changed anything. This is my business, and there is nothing that I would have or could have done to change: (1) to which reviewer the application was assigned; (2) the media firestorm that arose midstream about the risks of radiation emitting devices; or (3) the outcome of the Presidential election and the resulting 100% turnover at the CDRH. No consultant could have controlled any of those things. You understand that the entire industry is screaming bloody murder about the delays and incompetence at the FDA, and that includes the big boys that do use consultants and law firms for this process. I really don't think a consultant would have us in any different position than we are in right now.
you do agree that maybe Dean underestimated the process
Not sure what you mean by this. Dean admits that he never expected it to take this long, but I don't think that's a matter of underestimating the process. He fully understands the process and has done everything possible to get this through, he just got stuck with a crazy and incompetent reviewer the first time through, and then even with that obstacle, was on the verge of approval before another stroke of bad luck hit... an entire shake up at the FDA, with the reviewer, the reviewer's supervisor and the head of the CDRH all being kicked to the curb and replaced through the slow bleed that is political appointments and hiring. I don't think that's a matter of any applicant undersestimating the process, because those forces have nothing to do with "the process." We are where we are now, and all that matters to me is how things have progressed with the New FDA, and they have progressed according to plan, according to schedule and with all indications pointing to approval within the next 2 weeks.
you do agree we have heard "the check is in the mail" for a LONG LONG TIME now
We've heard Dean say that he's optimistic but that he can't control the FDA. The same as true today.
PS: i am sure you arent really going to agree with much of the above....
The one thing I do agree with.
News 
Market Data 
Discover 
