yoyo, page-10

Don't give up on the FDA decission - it will come through eventually. It may depend on the label claim. The FDA may want a number of limitation on when In Tube can be used (e.g. age of subjects, only immunocompetent subjects, etc) rather and a broad label claim for all LTBI testing. This would severely reduce the size of the market so CST would be right to "discuss" this with the FDA. This could be a reason for the delays.