InvestorsHub Logo
icon url

BennyJ

05/31/10 1:39 AM

#17417 RE: refillplease #17416

Following FDA approval:
Most likely buyout - Dean earlier estimated 60 to 90 days. Dean and Co now thinking that within 30 days. Market forces & Bidding war will determine the buyout price. NDA is in place with GE & Toshiba. Earlier Toshiba & Brainlab already visited the facility and expressed huge interest in DOMINION DVIS to proceed further.

Production - 100 to 150 machines in the first year. They have been talking with local & other OEM manufactures and oversees/offshore manufactures to meet the pent up demand for this product. Dean's statement is that hundreds of order already lined up waiting for the fda approval.

No clinical trials & No PMA route.




icon url

kimble1

05/31/10 10:05 AM

#17420 RE: refillplease #17416

clinical trials happen if they force them down the PMA route....that is essentially what a PMA approval process is