worth 1 dollar on fda approval, page-19

Here is annoucement at 2nd of August

Whos been starting to say that HGR haven't even

filled the form?? weird.


The Company advises that having completed the necessary studies the Company¡¯s subsidiary
Sun Biomedical Laboratories (SBL) has filed for US Food and Drug Administration (FDA)
510(k) clearance for the Company¡¯s urine illicit drug screening devices. Based on FDA
advice, SBL will recommence marketing of the Company urine illicit drug screening devices
for workplace testing in the USA effective immediately.
The Company delayed the urine filing to enable necessary resources to be deployed to
accelerate the important 510(k) clearance submission for OraLine IV, the Company¡¯s oralfluid
screening device. The Company¡¯s objective is to be the first manufacturer to realise
510(k) clearance for a saliva illicit drug test for in workplace testing in the U.S. With the
accelerated 510(k) clearance studies, the Company now anticipates filing by end of August
2007.
With no saliva tests having attained 510(k) clearance, the Company views the matter of
compliance with FDA guidelines as a strategic imperative that will provide a significant
competitive advantage in the U.S. market. All available resources are focused on delivering
510(k) clearance in the shortest practical timeframe.