Drugs with 'Fast Track'  or 'Breakthrough therapy' status are supposed to benefit from subpart H !

Phases durations are arbitrary fixed to :

  • Phase 2a : 4 months
  • Phase 2b : 12 months
  • Phase 3 complete : 36 months
  • Phase 3 intermediate (if subpart H)  : 18 months

If the lab provide the exact duration of the phase, the provided value is used. 

Recruitment duration is evaluated regarding the time needed by the leaders to compete their recruitment.

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