OI are privately funded and with dismal sales they must ready for some more cash. FDA will cost quite a bit, the value of the military trials to CST was $M's.
Their next big hurdle is FDA, it took CST 12 months to get through the process with Gold and it looks like the same will apply to in-tube. And that is with all the supporting data from the military and CDC. FDA like to run a fine tooth comb over the presentation and they may not appreciate the combination of 2 products for the OI application, T-Spot TB and Elispot. Elispot has been licensed in the US for years, for research only. Elispot is not a OI product and therefore cannot form part of the FDA process.
It will be interesting times for OI, my money is on the FDA throwing out the application.
oxford t spot, page-4
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