Dear Sick & Tired...re: Health Canada's directive...I believe it is similar to what the FDA just provided (but back in July-13). If I recall, Bioniche stumbled with the package being incomplete (I could be wrong here). Hence, the recent re-submission. See excerpt from press releases below. Now we wait. Time is on our side if BNC Management keeps delivering like they have since AGM. rg 07/10/13...Health Canada advised the Company that the data from the first Phase III clinical trial with Urocidin™ may be sufficient to qualify for filing under the NOC/c policy, but the regulator asked the Company to submit a clinical assessment package addressing some clinical questions as part of the request to file a New Drug Submission (NDS) under the NOC/c policy. Bioniche Provides an Update on Plans for a New Drug Submission Filing in Canada 07/10/13; https://www.bioniche.com/news_item.cfm?id=2336 03/06/14....Bioniche submitted its Clinical Assessment package to Health Canada in line with the mid-May guidance previously provided. Bioniche Provides Corporate Update https://www.bioniche.com/news_item.cfm?id=2354 S&T...now lighten-up with this.... https://www.youtube.com/watch?v=rIE2GAqnFGw