While we do not control the approval process, we are optimistic that we can address any of the agencies’ concerns in a timely manner and, although we currently anticipate that we will receive approval, we cannot give you an exact date for that to happen ...
We have, however, had discussions with the SFDA and they do understand the unique attributes and benefits of this test. With a fourth quarter 2006 approval unlikely, and while the exact approval timing is unknown, we are optimistic and are planning on a marketing launch based around approval during the first quarter of 2007.