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Re: $heff post# 77140

Friday, 02/07/2014 7:50:49 AM

Friday, February 07, 2014 7:50:49 AM

Post# of 97239
NAVB Decision from FDA regarding Priority Review for LS sNDA is expected by 2/17. If granted June PDUFA date expected. Next CHMP meeting week of 2/17. NAVB previously requested additional time to respond to questions from the December meeting so IMO possibly another month or 2 to come up for opinion.

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