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Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-67

  1. Ssrm0203
    9 Posts.
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    06/12/23
    19:47
    Post #: 71311305
    It's upto 6 months FROM resubmission, from rejection date wouldn't make sense. Vince did say the delay in launch from Q1 is 3 to 6 months but as other have mentioned the lawyer said, FDA will typically use the full 6 month time frame.

    https://hotcopper.com.au/data/attachments/5797/5797184-71616716f0e6d037b4a505c3073c26cf.jpg
    BOT Price at posting: 15.5¢ Sentiment: None Disclosure: Held
    Likes Created with Sketch. 6  Upvote
    lightbulb Created with Sketch.  Great analysis
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