"HDE applications are submitted to the Office of Device Evaluation at the Center for Devices and Radiologic Health (CDRH), which has 75 days to review the application. Criteria for HDE approval focus on safety, probable benefit, and lack of a comparable device. The application needs to provide data and a rationale supporting the probable benefit of the device and is exempt from the effectiveness requirements for a PMA device. During the initial 30 days, CDRH/FDA determines whether the application is complete enough to permit substantive review. If all the data appropriately support the HDE, the application is approved. If deficiencies are noted, the FDA notifies the sponsor as to their nature. As with other approved devices, the sponsor is required to manufacture and distribute the device according to established industry standards. In addition, the sponsor is required to maintain records of the names and addresses of facilities to which HUDs are shipped, in addition to correspondence with the Institutional Review Boards (IRBs) at each institution."

AGAIN, "If deficiencies are noted, the FDA notifies the sponsor as to their nature."

....so I guess a reasonable person can assume that since the 75 day review period has lapsed, there must have been deficiencies reported to BSDM by the FDA.....wonder why the shareholders have not been told???

???anybody out there??? what's going on at BSDM? What is everyone there doing besides playing golf?