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FOOD AND DRUG ADMINISTRATION - page 154 / 263

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Dr. Bolton?

DR. BOLTON:  I guess I have overheads.

First of all, I guess I should tell you some disclosures.  I'm speaking here on behalf of Geneva Pharmaceutical Company who has recently developed a thyroid product and gone through some bioequivalence tests.  This is the very first time, by the way, I've ever really worked with Geneva.  I must disclose, also, that I own stock in Abbott Laboratories and Forest Laboratories, and so that might sort of neutralize some of what I'm going to say.

(Laughter.)

DR. BOLTON:  First, I'd like to tell you what I aim to do here and that is, I aim to show you, in what I consider a very objective and scientific way, a look at the data that's been shown to me by Geneva, and I'd like to defend these studies as demonstrating that these products are equivalent and there's a very consistent measure of performance.

First, let's look at the design of these studies and understand that the FDA recognized that there was a great variability in thyroid products.  I think we

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