Some here seem to get lost on the length of time and blur actual events of product development with product substantial completion and the actual 510k application submittal for a final review.
Please understand that the Dominion has been in the development stages for four years as Dean communicated with FDA along the way. All the back in forth with the FDA prior to the April 5th submittal was just Dean doing his discovery as to what his reviewer was going to want for a successful 510K application review. The device was not substantially complete and not ready for 510K application submittal until end of first quarter 2010. The carrot that dangled for the investor was that approval will be the ultimate outcome mingled with ignorance of the amount time the process would take. Investor frustration and bitterness towards Dean is just the investor coping with their lack of understanding to the situation.
Development Stage:
7/6/09 Dean states that they are waiting to generate some low contrast high contrast CT imagery for the FDA for the comparative analysis process. 2D fluoro
7/6/09 Dean trimmed the product labeling " what he says he can do with the device". It is now basic real time fluoro, 3d imaging and ct scanning capabilities.
8/19/09 Dean just started seeing the 3d construct to develop he calls this stage two in development.
Stage three is plug in to the proto type. Stage four is real time. At stage four Dean could pull the images need to do the comparative analysis.
Substantial Completion:
Dean was at stage four of development at the end of January 2010. The quality of the 3d images progressed all the way to the submittal in April.
Dean just in the first quarter of this year achieved substantial completion for the Dvis. Meaning it could be use for its intended purposes. At this point the“actual”510K FDA review process could begin and with all the feedback Dean had received from the new review team he could put together a successful application.
I will admit I was ignorant to the time it would take for development. I was ignorant to the time needed to review the application. It was this ignorant perception of development and application review time that will cost me less of a return on my investment. If I had understood the process I could have played this different.
“Timing is everything”
Fortunately time has nothing to do with SE or NSE. Time only played with some investors emotions and blurred their vision.
#1 Dvis was substantially complete and comparative analysis in hand at end of first quarter this year = ready to submit 510K application
#1 The application was submitted in April and is under review with zero AI since submittal.
#2 The Dvis is by far better than anything out there.
#3 It will create a market of its own.
#4 This is one device that does the job of multiple devices.
#5 It will have a endless supply of additional applications.
Two big issues some investors have is: PMA and PPS / Money
As far as PMA
The 3d data set and how it ties in algorithmic process plus speed is was very hard for the FDA to understand. Just because they did not understand did not mean PMA route because this proprietary data only affects the speed and image quality of the Dvis. The Dvis speed and image quality is not only SE to the devices Dean compared to, it blows them out of the water. The algorithmic process does not change the intended use therefore does not change the devices used in a comparative analysis for 510K applications. The Dvis will be found SE.
As far as what Dean has done with money/ shares/ selling ect... It is beans and has nothing to do with the Dvis approval, market size, profit margin per unit, production cost and future applications. After approval the ends will justify the means.
This is how I see it. Best of luck HUBRIS
AI
