in the earlier 1August announcement, the company said they would be making application to the FDA in respect of the OralLine IV, oral fluid (saliva) screening device, by the end of August. Well tomorrow is the end of August so we could have an announcement!
"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."
HGR Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held