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covariants, and the requirement, as far as I know, is that all three of those methods must result in passing the bioequivalence criteria.  So, it puts the onus on this product a little more than it would on a usual product.

Also, we understand that the acceptance is based on a confidence interval, not on a statistical test, hypothesis test.  The other thing is that we're using subjects and not patients.  That's been mentioned before, and I think that's been really bandied about a lot by the FDA and the experts and so on, and we know that subjects are just a way of measuring whether two products are equivalent or not.  It's a mechanism or a machine that we put the product into and we look at the output.  We're not looking to see whether it's different between normal subjects and patients but just whether the formulations are performing the same way.  I think we all understand that.

So, let's go to the next slide.  You see, my understanding of bioequivalence is that if we have two products where the blood levels are absolutely identical, that any pharmacodynamic or therapeutic effects will be identical and any secondary effects will be identical

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