Health Canada question
As we await the announcement of the BLA submission to the FDA, I have a question that I never see anyone bring up, or perhaps I may have just missed along the way. What happened to the filing to Health Canada to see if MCNA (Urocidin) falls under the Notice of Compliance with Conditions (NOC/c) policy in Canada? That was sometime in early 2014 I believe. Was it, or is it, a non-issue since they decided to file a BLA submission to the FDA? In other words, if they get FDA approval they can go ahead and sell it in both the US and Canada without condions anyways, but what if the FDA or Telesta delay things longer for whatever reasons? Would it not be beneficial to at least get things going in Canada while waiting for this process to play out with the FDA whichever way the decision goes? How much different are Health Canada's policies than US Policies (FDA)?