In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
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