Ann: Opthea Completes COAST Final Week 52 Patient Visit, page-12

  1. 3,951 Posts.
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    A key point which is somewhat lost in all the other great info is the importance of FDA fast track.
    https://hotcopper.com.au/data/attachments/6818/6818118-1c6cfa9bf48777088183b357d6184221.jpg
    Firstly, only 33% of applications are approved for fast track which need to meet stringent conditions relating to unmet needs and likelihood of ph3 success.

    There is also evidence that drugs with fast track approval can charge higher prices - so it’s not just the reduced review timelines which are beneficial.

    more info is here: https://link.springer.com/article/10.1007/s10198-023-01639-x


 
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