We have now received our final No Objection Letter from Health Canada!
Our group has been actively working with NightStaRx Ltd. on finalizing the research agreement between this new biopharmaceutical company and the University of Alberta. This legal document will enable NightStaRx to supply the vector to us for the trial.
Two weeks ago, two members of our team along with a quality expert from TEC Edmonton travelled to perform an audit of the facility at Nationwide Children’s Hospital in Columbus, Ohio where the viral vector that will be used in our clinical trial was produced. The audit team provided a favorable review which is great news! This information will be necessary to import the vector to Canada.
We expect to select the patients for our trial in the next two months.