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steveporsche

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steveporsche

Re: DewDiligence post# 71590

Thursday, 01/15/2009 11:18:35 PM

Thursday, January 15, 2009 11:18:35 PM

Post# of 252233
This FDA to Sponsor memo has an interesting response on post-cut-off data. (Since it is a PDF file I could not cut and paste the text - hope the link works). Take a look at FDA response to question #5 in the top memo.

http://www.fda.gov/cder/foi/nda/2003/20-637S016_Gliadel_admindocs_P2.pdf
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