Vancouver, British Columbia – TheNewswire – November 9, 2020 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (the "Corporation" or "Blackhawk"), is pleased to provide the following corporate update.
The Health Canada Interim Order ("IO") application was completed and submitted for its SARS-CoV-2 IgG / IgM Rapid Test Kit. The extensive application was submitted November 4th and Health Canada confirmed receipt of the application the same day. Even though Blackhawk cannot guarantee timelines, the anticipated time to process the application is between 40 and 60 days. The SARS-CoV-2 IgG / IgM Rapid Test Kit currently holds Federal Drug Administration (FDA) Emergency Use Authorization (EUA) as well as a CE Mark in Europe.
About the SARS-CoV-2 IgG / IgM Rapid Test Kit.
The ExProbe SARS-CoV-2 TESTING KIT Interim order application has been progressing. On October 20 2020 we received a request for additional information from Health Canada. The information they were seeking involves 3 studies to be performed, given the complexity of the studies we requested until November 13, 2020 deadline to perform and submit the requested studies. The request was granted and we are confident that timeline will be met.
In addition to the above submissions, Blackhawk was also requested to prepare for its "Health Canada Virtual Domestic Inspection of Medical Device Establishment". In advance of the inspection, Blackhawk has review all its Standard Operating Procedures (SOP) ensuring they were updated. To date, the Corporation has submitted all required materials to Health Canada and is prepared for the inspection. The date for the inspection has not yet been confirmed.
"Busy is a severe understatement" said Frederick Pels, CEO Blackhawk. "We are pushing rapidly through the highest level of compliance and regulation in Canada. I view the requests from Health Canada as a positive and we are up to the task to meet them. We have been working on all other initiatives in tandem and will provide updates on them as soon as they become available."
For further information please contact:
Frederick Pels, Chief Executive Officer
Cautionary Note Regarding Forward-Looking Statement
All statements in this press release, other than statements of historical fact, are "forward-looking information" with respect to the Corporation within the meaning of applicable securities laws, including with respect to completion and review by Health Canada of interim order applications. The Corporation provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Corporation’s public filings under the Corporation’s SEDAR profile at www.sedar.com. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Corporation disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.
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