how important is fda 510k clearance

After the FDA grants 510k clearance to Oraline iv, it is almost certain to require clearance from ALL competitors. Clues to the possible impact of this requirement on competitors is provided in the following extract from an April 2006 disclosure document from a competitor (American Bio Medica Corp) undertaking a placement:

"Approval from FDA is not currently required for the sale of our products in non-clinical markets, but is required in the clinical and over-the-counter ("OTC") markets. Although our drugs of abuse products have met FDA requirements for professional use, we have not obtained OTC clearance from FDA. The workplace market is one of our primary markets and if any additional FDA clearance is required to sell in this market, this additional cost may cause us to raise the
price of our products making it difficult to compete with other point of collection products or laboratory based testing, thereby negatively impacting our revenues.

Furthermore, there can be no assurance that if we are required to apply for additional FDA clearances they will be granted. If such clearance is not granted, we would be unable to sell our products in the workplace market and our revenues would be negatively impacted.

Although we are currently unaware of any changes in regulatory standards related to the clinical and OTC markets, if regulatory standards were to change in the future, there can be no assurance that FDA will grant us the approvals, if and when we apply for them, required to comply with the changes"


http://sec.edgar-online.com/2004/05/10/0001144204-04-006202/Section2.asp