IHL 0.00% 4.1¢ incannex healthcare limited

General discussion, page-5309

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    Approval times for 505(b) 2
    The real time and cost saving for 505(b)(2) products comes from reduced development programs due to smaller and/or fewer studies rather than abbreviated review times.

    505(b)(2) Products Approved in One Review Cycle

    Of the applications approved via the 505(b)(2) regulatory pathway from 2009 – 2015, 64.5% were approved with only 1 review cycle. In some of these cases, preventable review delays occurred due to Refuse-To-File determinations, and the need to submit major amendments.

 
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