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  5. Exhibit 4-6 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-6 long description

The average number of FDA/sponsor meetings per Pilot 1 application (n=7) was 9 meetings versus 8 meetings in the comparison cohort (n=8). The average number of FDA/sponsor communications per application was 28 for Pilot 1 (n=6) and 38 for the comparison cohort (n=8).