Doc, you are absolutely WRONG. You obviously have NOT listened to the conference call I posted. It is NOT a variance of 5% in composition the FDA is concerned about, it is a variance of 5% in the results the FDA is concerned about.
Below I quote the text from the conference call where the CEO answered the question about the lack of antibody for the current Onko Sure test.
"Well, we.. we..at one point, we were..we didn't have a substitute antibody. Ah, we had a limited known amout of anitbody and we had no substitute. We then... when we figured that out, we then did some..you know..some work in identifing an appropriate antibody to give us the same results as the existing test because we cannot have a variance of more than 5% or we have to file an new filing with the FDA. So, we were able to do that and that risk has been eliminated now and in the future. So we've got plenty of materials to make unlimited kits at this point."
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