Radient Pharmaceuticals Corporation fka RXPC

[Future Doc]

I listened to the conference call again. I don't think it is conclusive as to whether he was referring to variance in the specificity/sensitivity of the test or the ability of the test (i.e. binding efficiency of the antibody). You are assuming by "results" that he means the accuracy/specificity/ sensitivity. I don't believe that this is necessarily true. Would the FDA require some company to submit a new proposal if they started getting better numbers with a similar antibody? Logically speaking, I don't see a reason why they would.

I need to find out the definition of "results" according to the FDA for this 5% "result" difference. What if "results" only considered sensitivity? What if they only considered specificity? What if considered a different measurable all together? It is inconclusive in my opinion and allows for the possibility of the specificity/ sensitivity to be higher in the NEW test.

If you can find any pertinent information, can you please provide it. Thanks in advance.