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the risk in the newborn I've already mentioned.

My concern is that the current assessment of bioequivalence is not adequately sensitive to detect these small differences that matter.  These are the real concerns and experts need to decide on a new approach that will address these concerns.  Anything less, such as continuing the current bioequivalence standard, would be a disservice to we practicing physicians and our patients.

I'd like to turn it over now to Dr. Granneman who will demonstrate how the current bioequivalence criteria perpetuate presumptions of bioequivalence that create the potential for the adverse clinical consequences that you heard about from all of the physician speakers this morning.

Thank you.

DR. GRANNEMAN:  I'd like to thank the FDA and the committee for inviting us to talk about the results of our study and various baseline correction procedures.

Although we will spend a lot of time talking about the ways that you can correct for endogenous T4 products, there's a larger question that we have to consider.  Ultimately, we have to ask the question, does

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