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FDA Application for Orphan Drug Designation , PAA, MPL, page-86

  1. 2,965 Posts.
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    hi @theoc, perhaps this (from the good Dr T) might calm the nerves:

    "........closing out a study takes months. We don’t put out preliminary results as all the data needs to be source verified and collated to support database lock to allow a robust statistical analysis of the results to be completed.Cohort 4 has finished dosing but patients still need to complete their follow-up visit 35 days after their last dose."


    Cheers

 
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