Thursday, May 05, 2016 1:28:45 PM
These submissions are for the FDA and not EAMS. Multiply the effort and confusion by 2. The fact that we are working with the FDA so closely really has to work in our favor. Remember, it is thier job to make sure we do ours. The SAB committee should have been started much sooner but better late than never especially since things are intensifying now. There is just so much involved in a major regulatory approval.
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