Why so long between updates?, page-44

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    Cr's are obviously significant and important to tell us about the data/efficacy. However the designation of fast track and ODD, has no relationship at all to the data and its efficacy.

    To put it another way, granting of ODD/Fast-track does not mean well the data must be good/bad or otherwise.

    But ODD is just about treating a rare disease, and fast-track is about serious unmet need. So it gets granted if you are treating a particular disease in a particular category.
    That's my understanding anyway.

 
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