Anavex Life Sciences Corp (AVXL)

[bas2020]

For those having trouble finding or talking about the EMA's 150-day AA procedure, here's the process... which includes one "clock stop".

Accelerated Assessment Procedure 
 - Day 1 Start of the procedure. 
 - Days 1 – 90 First assessment phase: 
    • CHMP Rapporteurs’ assessment reports 
    • PRAC Rapporteur updated assessment report 
    • Peer-review 
 - Day 90 CHMP plenary meeting with adoption of either: 
    • CHMP positive opinion; or 
    • CHMP list of questions to the applicant to be addressed in writing and at an 
      oral explanation if necessary with maintenance of the accelerated 
      timetable. The CHMP may also adopt questions for a Scientific Advisory 
      Group, as applicable; or 
    • CHMP list of questions to the applicant to address in writing and at an oral 
      explanation if necessary with switch to a standard timetable (see 5.3). 
 - Stop of the clock: One month stop of the clock by default. 
 - Clarification meeting will be planned shortly after adoption of the list of questions. 
 - Day 91 Restart of the clock following submission of the applicant’s written responses. 
 - Days 91 – 120 Second assessment phase 
    • CHMP and PRAC assessment report of the responses 
 - Day 120 CHMP plenary meeting with adoption of either: 
    • CHMP positive opinion; or 
    • CHMP list of questions to the applicant to address in writing if necessary 
      with maintenance of the accelerated timetable; or 
      Guideline on the scientific application and the practical arrangements necessary to 
      implement the procedure for accelerated assessment pursuant to Article 14(9) of 
      Regulation (EC) No 726/2004 
    • CHMP list of questions to the applicant to address in writing and at an oral 
      explanation if necessary with switch to a standard timetable (see 5.2). 
 - No Stop of the clock: The CHMP would request the submission of the written responses without clock-stop 
 - D121 Submission of written responses 
 - Days 121 – 150 Third assessment phase: 
    • CHMP and PRAC assessment report of the responses 
 - Day 150 CHMP opinion