Anticipation of FDA approval is growing. This approval is for the 'supplement' to the original approval originally granted November 2001.
Whilst the FDA panel decision was unanimous they did call for further tests to clarify some areas; these have been completed and results form the 'supplement'.
The protocol indicated by the FDA is that the supplement approval process is for 180 days (hence the title '180 Day Supplement') and Cellestis lodged their 900 page application on 16 December 2003.
Contingent on approval are major contracts; evidence of US military requirements of Quantiferon testing for service redeployments from and to Europe has already been sighted.
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