FWIW, the notes I jotted down from the CC today (10:05-11:03 AM PDT, ~700 listeners):
- FDA letter rec'd yesterday asking only one question, clarification of "intended use" (such as the label on a drug bottle), Dean is happy that this is the only concern, should have his response back to the FDA by Friday, 11/6, then figure the standard 15 days for FDA acknowledgment and 30 days for response, though approval could come at any time, and will be first announced by press release when it comes.
- Hoping for approval prior to RSNA (4 weeks off).
- If no approval by then, will continue to market at RSNA (but cannot accept actual orders); with approval, will be taking orders.
- Open to considering buyouts as well as "going it alone", but think M&A most likely. There are many potential distributorships as well as potential private labeling.
- There is no comparable device on the market today in terms of real-time 3D at dose rate much lower than a CT.
- Images are QA (???) as opposed to physics or scientific images, the human body is much harder to image than inanimate objects.
- Upon approval, may produce 10 to 100 devices in the first year (need to be deliberately vague here), depending on demand (more demand limited than production limited). Current 10,000sf facility can handle hundreds of units per year, nearby facilities are available for expansion if needed. Has enough capital on hand to move directly into significant production.
- Expect about 30 days between first order and first delivery. Currently has "hundreds of leads" that could turn into orders, but cannot accept any $$$ deposits until approval.
- Will eventually expand sales world-wide.
- Dean's feeling, based on prior FDA approval experiences, is that, though Dominion approval has taken much longer than he thought it would (or should) take, it is close, possibly days to weeks.
- Will go for Euro and international approval after FDA approval.
- Dominion has other potential non-medical applications, such as non-destructive testing and homeland security, will explore those in the future, maybe 6 months to a year after FDA approval. The system is "scalable", can be sized up, DARPA interest?
- Will contract servicing and tech support rather than have a large in-house work force.
The above is as I heard and jotted down, sorry if I missed some important items or got something wrong. GLTA.
NC
