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05/04/16 2:24 PM

#198163 RE: Jimmy Joe #198150

An actual case for Vericel's BLA request has been provided for the additional 6 month wait.

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's was on March 17, 2016.