Fair to say FDA requirement for a further trial by Uniqure before Glybera gets US approval supports benitec's go slow and get it right first time approach.
UniQure mulls options for $1M gene therapy after FDA demands extra trial
August 27, 2015 | By Nick Paul Taylor
The path to bringing a gene therapy to market in the U.S. just got a little rockier. Having expected to swing for approval in the U.S. on the basis of one pivotal trial, uniQure ($QURE) has now learnt the FDA is demanding another clinical study.
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