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K-G

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Alias Born 10/25/2006

K-G

Re: K-G post# 28517

Friday, 09/11/2009 3:59:48 PM

Friday, September 11, 2009 3:59:48 PM

Post# of 50184
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.
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