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So a couple of different comments.  First of all, when you're approaching it as the IPAC-RS has in setting an acceptance criteria, whether it's this particular acceptance criterion or some other number, what you're really saying is anything that falls inside that curve should be acceptable.  Now, this is really like bioequivalence, if you want to go back to that.  You set a limit of 80-125.  That really means that 124 would be acceptable.

Now, in practice, you're not going to see that because the size of the study required to get something 124 to pass would be unreasonable.  So you're never going to actually see that and actually Dr. Olsson really alluded to that in a different way by indicating that batches really need to be substantially inside that red curve in order to have a good chance of passing.

The other comment to make is really relating to the second question that Wally had put up for this committee, and that's really that if you take this approach and say that the role of FDA is essentially to set the stake in the ground and set the quality limit, then the batch failure rate for batches that are

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