ans,
I had a brief conversation with my statistician friend. There are ways to exclude particular datum from a particular study, but if the protocols are considered flawed by US standards, the study data can not be considered. Hate to seem like a downer a bit here, but I am a realist.
I have the transcript from the FDA meeting in June 2004 where the stats guys talked about the data.I want to look closer at this and maybe get my friend to look at it. He recently lost his dad and is trying to make up 2 weeks worth of work at the moment, so this will have to wait until next week. Hiring a stats consultant would help with this process. I will also ask how much it might cost to do so.
Also, I found an internet book on the appeals process. I downloaded it but did not have a chance to read it last night. I will look at it tonight.
Patty
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Patty
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