In the ASX release of 30.04.2007 the company stated
"In compliance with the warning notice the Company has withdrawn OraLine and other products from the US market until either the 510(k) clearance is realised in approximately four months or alternatively it receives advice that marketing may proceed."
It would appear FDA processing for Oraline is underway...I point this out simply because a few posters have suggested that the FDA process has not even started yet.
I read it differently and further still....4 months on from 30.04.2007 gives us the end of August. Or imminently
EB
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