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Re: pkdaddy64 post# 1163

Sunday, 10/24/2010 1:08:21 PM

Sunday, October 24, 2010 1:08:21 PM

Post# of 22684
A class 1 is expected to have a very fast response time from the FDA. As I understand the process, the company presents the re-submission and then the FDA responds within a couple of weeks with an acceptance letter and a re-submission classification, and if they indicate that it is Class 1 then the PDUFA date should be only a couple of months after the acceptance letter. So if Arena gets their re-submission together within several months and gets a Class 1 acceptance then we could be looking at a new PDUFA date as soon as say 6-8 months from now.