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KCSVEN

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KCSVEN

Re: KCSVEN post# 16354

Friday, 10/11/2013 1:42:56 PM

Friday, October 11, 2013 1:42:56 PM

Post# of 426692
REDUCE IT is mentioned but considering having reduce it underway was part of the agreement and the main focus is efficacy and nothing related to safety it is pretty straight forward. FDA has said underway is enough, panel should agree with no safety issues mentioned it will be OK to approve.

Expect near unanimous approval on this

Agenda is up also
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