Chances are good, the primary approval has already been given and this is for the outstanding items re the CDC list.
Also the CDC have been running and working on the tests so it appears to be formality.
Another encouraging sign is the change in testing requirements to Quantiferon by the US army medical centre who, coincidentally, also ran some of the tests for the FDA approval process.
Plus the recent signing up by the distributors of the TST product by Cellestis to distribute QFT ie Statens in Europe and BCG in Japan.
So all the signals are looking positive.
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Chances are good, the primary approval has already been given...
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