Calm down and think about this for a moment.
Nobody is invested in Imaging3 because of the daily up and down (mostly down lately) of its share price. You are not invested in Imaging3 because of its C-Arm refurbishing business. You are not invested in Imaging3 because of its current revenues. Every single one of you invested in this Company on the belief that it would obtain FDA Approval of its breakthrough medical imaging device, the DViS. So rather than evaluating the current (inexplicable) drop in share price, or over-analyzing its balance sheet, or asking the CEO to hold your hand through this frustrating time, simply do the following: analyze what we know about the status of the FDA application and decide what you think is the likelihood that we will get approval. Here are the facts:
Prior to late fall 2009, Dean was working with a different review team, so I think you have to throw out everything that happened before then. Beginning with the new review team and the new head of the CDRH, the FDA came to Dean, apologized for how long the process had taken and committed to do a complete and thorough review of his file, identify every subject about which they may have questions and give him one complete set of questions. They did that, and in December came back with a list of 18 questions and follow-up requests. 17 of those items were addressed by phone and email to the satisfaction of the FDA. That left only one item, the Radiologist Review. We know from the video updates and conference calls that Dean provided to the FDA a Review from two third party expert radiologists an analysis that he would not have sent if it was anything short of glowing and concluded that the images from the DViS were substantially equivalent to the images from the predicate devices. We know that after a couple of weeks with the application, Dean and the FDA exchanged a couple of calls and emails during which the FDA made a couple of minor requests that were responded to immediately. We have now heard from two people, drpolk on Yahoo and gdsgds on this Board, that they heard from the Company that the requests were for 2 minor wording changes in the manual and to have the application materials provided in a format that cannot be modified or redline edited (either PDF or hard copy). We know from the FDA's website that the "FDA generally requests AI by means other than a letter when the agency believes the additional information is relatively minor in nature (e.g., a simple change to the device's proposed labeling) and can be provided quickly," and "an informal AI request does not result in the 510(k) being placed on 'hold.'" So we know that it's not just Dean's, Mike's, drpolk's or gdsgds' opinion that these three requests were minor, we know that the FDA considered them to be minor. We know that nothing else has been requested or raised by the FDA and we know that all information they have requested has been provided. We also know that Dean has insisted that he would not post a new 3D image or video of 3D images until FDA approval was in hand or the FDA expressly authorized him to do so because approval was imminent. We also know that gdsgds was told that Dean was working on a video demonstration of the DViS generating 3D images.
Considering all this that we know for a fact, I just don't see how anybody can reach a conclusion about the likelihood that the FDA's decision, whenever it comes, will be anything other than a finding of Substantial Equivalence. And if that's what all the facts suggest is the likely outcome, all the other noise is irrelevant. Just try to be calm and think about these facts. That's what I'm doing.
