QRX 0.00% 2.8¢ qrxpharma ltd

sales and revenue examples, page-14

  1. 1,057 Posts.
    for anyone who's interested, the FDA resubmission procedure...

    http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082002.pdf

    the CDER classifies resubmissions into one of two categories:
    - class 1: 2 month review
    - class 2: 6 month review

    they advise which class they have assigned to the resubmission 14 days after submission.

    interestingly class 1 resubmissions includes...

    ''8. A minor re-analysis of data previously submitted to the application (determined by the FDA as fitting the Class 1 category)''.

    I guess they already have a feeling that it will be a 'non-minor' review and will take 6 months.
 
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