IND/CTA/CTN/CTX Timeline

  • Japan Plan Pre=CTN meeting

  • Japan - send information for Pre CTN meeting

  • Canada Plan Pre-cta meeting

  • non clinical 12-36 months prior to submission

    12-36 months prior to submission
  • EU - Plan Pre-CTA meeting

  • Australia CTX & CTN get Certificate #

  • Canada - pre cta meeting

  • US Pre-IND Meeting

  • Canada - meeting minutes sent

  • US IND Submission

  • EU Submit CTA

  • Canada CTA submitted

  • Australia - submit CTN or CTX

  • Australia - CTN approval begin trials

  • EU - CTA approval granted

  • US IND 30 Day Safety Review

  • Canada - begin trials NOL or 30 days

  • US Clinical Trials

  • Australia - CTX - begin trial

  • Plan End of Phase II

  • End of Phase II Meeting

  • Plan submission meetings

  • Pre - submission meetings