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floblu14

04/28/08 4:35 PM

#10362 RE: palindromy #10361

From 4Q CC -

Geoffrey Cox

>.... I can not really give any guidance on that{Advisory Panel} to be quite honest. We have not been given any guidance by the FDA at all at this juncture. Certainly, I have had people who have told us that they believe that we will have an advisory panel since it is a new technology. And if we do, I think we feel very confident of our ability to meet that challenge in a very successful fashion. But I really can not give any guidance. If it does happen, and we have a priority review status, then I guess it would be somewhere in the latter part of 2008 if everything sort of proceeds on the sort of schedule which we see at this moment. I do not have any other information on the matter at this moment....<

Also, I will check these from time to time --
http://www.fda.gov/oc/advisory/accalendar/2008/2008ACcalendar.html

http://www.fda.gov/oc/advisory/accalendar/2008/2008TentMtgSched.html