When the FDA gave written notice in Mar 2016 for $ELTP SequestOx their official PDUFA date of Jul 14, 2016, they had thoroghly examined all of $ELTP 40 Person HAL and 163 person P3 data. No questions remained.
As well the FDA gave a Priority Review which is a 6 month earlier than normal review. Another Pharma that I follow with their new BLA submitted for FDA approval at the same time is scheduled for Jan 2017 PDUFA.
IF the FDA had any more questions they never would have given priority review for Jul 14, 2016. It is set in concrete. No questions remain.
Elite Announces U.S. FDA Priority Review Designation for SequestOx™ NDA
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