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K-G

09/11/09 3:59 PM

#28520 RE: K-G #28517

I think my biggest mistake was not selling everything and running when Stoll mentioned the 6 foot box of data. The alarm bells sounded loudly at the time. Even though I've never dealt with the FDA, I cannot imagine when it is ever appropriate to send that much data to anyone to support a decision. In my work, if I can't justify a position in a less than 100 page report (with all supporting data available for inspection, if requested), I'm dead.