IND/CTA/CTN/CTX Timeline By smychynsky Sep 1, 2009 Japan Plan Pre=CTN meeting Sep 21, 2009 Japan - send information for Pre CTN meeting Oct 1, 2009 Canada Plan Pre-cta meeting Oct 1, 2009 non clinical 12-36 months prior to submission 12-36 months prior to submission Oct 1, 2009 EU - Plan Pre-CTA meeting Oct 1, 2009 Australia CTX & CTN get Certificate # Nov 1, 2009 Canada - pre cta meeting Nov 15, 2009 US Pre-IND Meeting Nov 15, 2009 Canada - meeting minutes sent Jan 1, 2010 US IND Submission Jan 1, 2010 EU Submit CTA Jan 1, 2010 Canada CTA submitted Jan 1, 2010 Australia - submit CTN or CTX Jan 10, 2010 Australia - CTN approval begin trials Jan 31, 2010 EU - CTA approval granted Jan 31, 2010 US IND 30 Day Safety Review Jan 31, 2010 Canada - begin trials NOL or 30 days Feb 1, 2010 US Clinical Trials Feb 19, 2010 Australia - CTX - begin trial Jan 1, 2012 Plan End of Phase II Mar 1, 2012 End of Phase II Meeting Jan 1, 2015 Plan submission meetings Mar 1, 2015 Pre - submission meetings