The Mexico export certificate (announced yesterday)has been granted by the FDA - surely this means that the FDA are now feeling more comfortable with HGR's products and getting the US workplace certification by the FDA could be well on the way potentially. See a copy of the announcement:
"Harrington Group (ASX: HGR) is pleased to advise that the Company’s subsidiary Sun
Biomedical Laboratories (SBL) has been granted a certificate of exportability from the
U.S. Food and Drug Administration (FDA). This enables the export of OraLine IV, the
Company’s premier oral fluid illicit drug screening device, into Mexico.
Subject to acceptance by the Mexican government, the Company anticipates
commencement of shipping of OraLine IV in September 2007. A significant
distribution partner to SBL, Express Diagnostics, has been working with the Mexican
government where it is intended that OraLine IV will be used for testing programs
being implemented in the Mexican schools system. In its war against illicit drugs the
Mexican government has introduced mandatory drug testing in schools. The
Company is confident that the Mexican market will deliver significant volumes and
that the model of mandatory testing in schools is likely to be adopted in other
markets.
As previously advised the Company remains committed to, and continues to work
toward the realisation of FDA 510(k) clearance for OraLine IV for workplace testing
programs in the U.S."
Its all good ...
HGR
unknown
