Here are my notes of the highlights of the call:
Dean's Remarks:
Over 1,000 participants on the call.
Original reviewer from FDA for our application is gone, as is the head of the CDRH. Accordingly, we have to get new folks to a comfort level. They have been engaged and been reviewing and have come come back to the Company with some more questions / respnoses (18 total items):
14 clean-up application suggestions (service manual and other information to clean-up)
3 information requests (related to engineering and test information, mostly regarding information that has already been provided and follow-up re: vibration, structural integrity and other technical issues)
2 actual questions (interpretations of imagery).
The most significant follow up request is that the FDA would like us to have a radiologist provide a Comparison Review Opinion. CEO has good relationships with many radiologists, and many radiologists (hundreds of them) are investors in the company, so the Company should have no problem finding a radiologist to do this quickly. Will also need to obtain images from other competing machines to compare with DViS images. CEO has gathered that the FDA does not have a radiologist on staff, so they want us to have the file papered with a blessing from a radiologist.
CEO has a call scheduled with the head of CDRH and the reviewer to discuss the requests, get clarification and agreement about an acceptable response.
CEO expects to have response to FDA by mid-February (could be sooner, could be a little later). Most of the items should take no more than 2 weeks to respond to.
Process has taken far longer than CEO expected. He feels as confident as ever that we're going to get this through. CEO expects approval by the end of the first quarter or the very beginning of the second.
Q & A:
Question about burn rate / cash on balance sheet / earnings. Company has more than enough capital to survive this delay. We have adequate capital to survive this entire next new year, and in addition, I have also obtained a credit facility in excess of $900,000 (not yet drawn upon).
Question about making images available to shareholders: Trying to get images on website as we speak. Hope to have them on the web shortly.
Question about where CEO thinks we are in the FDA process: In these type of reviews, you don't tend to go backwards. What's good about this follow-up inquiry from the FDA, like the last one, is that the questions being asked are in a pattern of "clean-up and clarification." Many of them were already answered or are in the application itself. Most importantly, there's not a single question about the technology. They were mostly questions about our application. 2-3 with any meat at all, and even those have to do with clinical comparisons, which is a very good sign.
Question about FDA not agreeing that 510k is the right application: FDA is on board with our product being substantially equivalent.
Question about communications with GE or Toshiba: CEO has a conversation with them coming up and a meet and greet with them in a couple of weeks. We're open to manufacture and take this to market ourselves, but would also be willing to partner with the big industry players, or do whatever makes sense, including an acquisition. If the price is right we would consider an M&A.
Question re: impact of Health Insurance Reform: CEO believes the health care reform really helps us. Our product does multiple procedures, it's mobile, and it's less expensive. That's what the reform effort has been all about.
