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Ann: Path Forward For Resubmission of MOXDUO NDA , page-5

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  1. 1,057 Posts.
    re: Ann: Path Forward For Resubmission of MOX... For NDA's reviewed by an Advisory Committee (AC) in the period Jan 2012 to May 2012:
    - there were 12 in total
    - 6 were supported by the AC
    - 6 were not supported by the AC
    - of the 6 supported all were later approved by the FDA
    - of the 6 not supported all were later received a CRL form the FDA

    I was intending to check this for the year but the 5 months tell me what i needed to know:
    - AC's favour neither positive nor negative outcomes
    - the AC's recommendation is likely to be echoed by the FDA

    All scheduled past and future meetings are here. You need to do a little googling to get the data i summarised above though:
    http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
 
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