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Japan Plan Pre=CTN meeting
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Japan - send information for Pre CTN meeting
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Canada Plan Pre-cta meeting
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non clinical 12-36 months prior to submission
12-36 months prior to submission -
EU - Plan Pre-CTA meeting
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Australia CTX & CTN get Certificate #
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Canada - pre cta meeting
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US Pre-IND Meeting
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Canada - meeting minutes sent
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US IND Submission
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EU Submit CTA
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Canada CTA submitted
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Australia - submit CTN or CTX
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Australia - CTN approval begin trials
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EU - CTA approval granted
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US IND 30 Day Safety Review
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Canada - begin trials NOL or 30 days
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US Clinical Trials
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Australia - CTX - begin trial
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Plan End of Phase II
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End of Phase II Meeting
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Plan submission meetings
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Pre - submission meetings