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size of intermediate expanded access

  • 1.  size of intermediate expanded access

    Posted 22-Aug-2015 08:28

    In your experience what is the average size (no. of patients) that would be considered as "intermediate"? None of the regulations or guidances specify a number other than to indicate it is usually smaller than a study protocol.

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    Elizabeth Ashraf
    Director Regulatory Intelligence
    PTC Therapeutics
    South Plainfield NJ
    United States
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