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FOOD AND DRUG ADMINISTRATION - page 229 / 263

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smiling at me.  Marv will start.

DR. MEYER:  First of all, I'd like to compliment Abbott as FDA has done.  So oftentimes, we have the innovator company whine about differences, perceived differences, imagined differences, extrapolated differences, simulated differences, and they never come in with real data.  So I think Abbott has done a good job of trying to gather some data, and I personally appreciate that.

A couple of questions I have.  It seems to me, in my non-endocrinology background, that TSH is much like measuring blood pressure.  A clinician might like to see changes in blood pressure and an endocrinologist might like to see changes in TSH, but if you can show what's going on with a drug you're administering, given an appropriate baseline correction, it seems to me that that's the appropriate thing to do.

I'm a little troubled by repeated reference to 12.5 milligrams as being critical to patient therapy, and I didn't see any data.  Now, there may be a lot of physicians know that that's true, but the data in the literature all seems to revolve around the Carr study.  

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