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Tuesday, December 05, 2017 1:11:36 PM
$ELTP NH has stated that it was Dr. Sharon Hertz that assured $ELTP that SequestOx would be okay with label directions when Dr. Margaret Hamburg was Commissioner in 2014/2015. This led to the successful 163 person P3 bunionectomy
It was new Commissioner Dr. Robert Califf that denied SequestOx approval in Jul 2016 and then subsequently approved Pfizer's Troxyca in Aug 2016
So then you may possibly have the opportunity to present your SequestOx support data should there be an AdCom for SequestOx under new Commissioner Dr. Scott Gottlieb?
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