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Benitec Receives Final Confirmation of Positive RAC Meeting

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Benitec Biopharma announced last week that it has received a written report confirming a favorable review of a planned phase I/IIa clinical trial for its expressed hepatitis C treatment from the National Institutes of Health’s Recombinant DNA Advisory Committee.

The company said it made “minor” changes to the study’s protocol after meeting with the committee and has requested a pre-investigation new drug application hearing with the US Food and Drug Administration.

The company expects to begin the trial before the end of 2013.

In June, Benitec announced that its meeting with the RAC has been positive (GSN 6/13/2013).

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