Wednesday, May 04, 2016 8:00:10 AM
Canada is waiting for SequestOx as are the Global mkts IMO.
As for the FDA, by designating "Priority Review" for SequestOx, they have moved forward the PDUFA date to Jul 14, 2016. In comparison to other NDA and BLAs that I follow this apparently is a 5 to 6 months advancement for SequestOx.
For example Vericel MACI™ BLA which submitted on the same time period as SequestOx has a PDUFA of Jan 3, 2017, which is a six month longer wait. Vericel's FDA acceptance was on March 07, 2016, and $ELTP was on March 17, 2016.
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