spp help, page-34

Tim and Vintage,

Thanks for your responses.

Since the majority of illicit drug testing in the US is urine based, there is still a significant percentage that utilises products with some degree of oral functionality but these are predominantly used in closed markets (non retail Medical or Govt agencies ie Police. I understand that whilst certain legislative input may be required in some States, many are waiting for the less invasive and far simpler oral testing procedures. Put quite simply, since a great number of SBN clients will be Govt aligned organisations,they will not implement oral based testing procedures without FDA clearance. The economics and logistics of moving from urine to oral based methodologies with FDA clearance is compelling. Apart from exploiting these growing markets, the FDA validation for both SNB's urine based product and Oraline provides the company with a massive commercial advantage both in the States and throughout the rest of the world. There is little doubt that the SBN strategy involves the consolidation of global distribution agencies and alliance partners so that once FDA approval is given, they are ready to hit the specific markets having sounded out customers that have indicated their preference for the oral based drug testing product. Whilst this transition process is underway, it provides SBN with the opportunity to additionally market its urine based drug testing product to those clients who have elected to stay with urine based testing or have not transtioned as quickly as others to the oral based product.
But the bottom line is clear. Once FDA clearance is given, the commercial opportunity and first mover advantage for a small company like Sun Biomedical is nothing short of massive. In many ways, it is a relative measure. The ultimate key to success will be the matchup of manufacturing capacity with the associated quality control process of product membranes that together, will meet the anticipated market demands.


ciao