the process of the FDA is an arduous one with many meetings...

the process of the FDA is an arduous one with many meetings being held in the process. But once the announcement is delivered tomorrow then we go into "pre-submission meeting" a lot of work has already been done and with Experien Group holding our hands through the process having a 99%  approval success rate, this is really a waiting game as Rap will be a game changer.IMHO

• Regulatory strategy - DONE
• FDA communication   - DONE
• PMA submission - DONE
• PMA Supplement submission  -DONE
• FDA Panel meeting   - DONE
• de novo petition    - DONE
• HUD and HDE application - DONE
• FDA Q-Sub process - DONE
  • Informational Meeting   - DONE
  • Pre-Submission Meeting - this is where we are at I believe in the timeline for FDA
  • Submission Issue Meeting
  • Agreement Meeting
  • Study Risk Determination
  • Determination Meeting
  • Day 100 Meeting

• http://experiengroup.com/services/regulatory/