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Msg  463927 of 548858  at  5/22/2011 1:27:36 PM  by

Sam I Am


Re: Russel Katz, Head of FDA Neurology is very clear that they wont approve an AD drug solely on the basis of a secondary endpoint such as PIB Pet and change in CSF Tau. Want real effect on cognitive and functional. EOM

http://www.alzforum.org/res/com/videogallery/default.asp

Watch these two videos. Katz is willing to give priority review and also accept a drug that has risk if efficacy is strong.


3. The Progress of Drug Development. A group discussion at the 2008 ICAD conference in Chicago, moderated by Maria Carillo of the Alzheimer's Association. Features Paul Aisen, UCSC/ADCS; Richard Frank, GE Healthcare, Russell Katz, FDA; Marcelle Morrison-Bogorad, NIA; Lennart Mucke, UCSF/Gladstone Institute, Dale Schenk, Elan Pharmaceuticals; Eric Siemers, Eli Lilly and Company


4. Approving Drugs for Alzheimer's. A conversation with Russell Katz, FDA


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