In what is a major blow to shareholders of Sona Nanotech (CSE: SONA), the company this afternoon announced that it has withdrawn its rapid COVID-19 antigen application from Health Canada based on feedback it has received from the regulatory agency. The move is being conducted “in order to obtain more clinical data to augment its submission.”
While the application for approval has been withdrawn, the company indicate that it will “continue to pursue approval” of the test from the agency, which is a nasal swab-type test. Sona is also reportedly continuing to validate its saliva-based version of the rapid test. Now, the company will be looking to conduct a large scale trial for this saliva-based test.
Despite withdrawing its application for an interim order authorization from Health Canada for the marketing of its test, the company continued to state within the news release that it’s “COVID-19 antigen test offers results within 15 minutes.” The company also reiterated that testing has shown an agreement with RT-PCR tests 85% of the time, along with 96% sensitivity.
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Commenting on the withdrawn application, President and chief scientific officer Darren Rowles stated, “The regulatory approval path for antigen tests is new with evolving guidelines and Sona’s test is unique, creating a challenging environment for test developers and regulators alike.” He then followed up that statement by indicating the company is committed to obtaining the data required.
A timeframe for the required data collection to proceed with Health Canada authorizations was not provided by the company. The company has indicated that it intends to resubmit its application as quickly as possible
Sona Nanotech last traded at $3.11 on the CSE.
Information for this briefing was found via Sedar and the companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
