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FOOD AND DRUG ADMINISTRATION - page 90 / 263

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And then the biggest cost is not passing when you should pass, and so potentially by giving sponsors control of their study design and hence of their producer risk, there's at least potential reduction in cost there as well.

So the bottom line really goes back to where I started in the first issue.  The message, if you will, is to not spend time on the statistical issues.  At the end of the day, take the statisticians, throw us in a room.  If we ever agree on anything, let us out.  That might be a long meeting.  But I think the primary issue for this committee and for the FDA is really what's the limiting target.  What is an acceptable batch once you get to market?  And as I said, that's my bottom line for you.

Thank you.

DR. KIBBE:  Questions?

DR. KORCZYNSKI:  Just so I understand the topic a little better, we've heard of dose uniformity here in these presentations.  What's the relationship to aerosol particle size?  Because that would influence the availability of the drug relative to uptake by the respiratory system.  Is that an independent variable?  Is that measured in a separate set of tests, and is that

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