Monday, June 06, 2005 11:27:49 AM
You are right. There are 2 standards to go by. There is a standard set by the FDA and this has already been met. I think the FDA standard is some where in the lower 90 percent range. The Second Standard is set by the Scientists and the Market.Here you want as close to 100 % as you can get or someone else will come along and knock you out of the game. Ex. - If you stop at say 93% to met the FDA requirments than whats to stop comp. abc from banging you out of the market with a test that has 100 %. Dnap could have already applyed for FDA approval yet is still running clinical test with Moffit to refine and get it up to 100%.This is just what they are doing with Retinome.
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