Sona Nanotech (CSE: SONA) this morning elaborated on its decision to withdraw its antigen test from an application for an interim order authorization following the receipt of further data from Health Canada. At the core of the firms decision, is testing results from Health Canada were “discordant” with results from the firms prior analytical and clinical studies conducted by that of MRIGlobal and SaudiVax – essentially, the results didn’t match.
Commenting on the process of evaluation conducted by Health Canada, the company looked to remove blame from itself by stating, “The Company had several fundamental concerns with respect to the generic evaluation process followed that did not take into account the unique characteristics of the Sona test.” Following the testing, Sona withdrew its application in order to collect further clinical data.
The company is now required to obtain more data on the performance of the test, which involves obtaining sample from patients within zero to six days since symptom onset.
With regards to future plans Sona has identified that it intends to “close the discordancy” on its nasal test while pushing forward with certification in the EU and Saudi Arabia. Future data collected meanwhile will be used for its submission with the FDA and “potentially” for a resubmission to Health Canada. The company also intends to push forward with developing its saliva-based COVID-19 test, as well as other non-COVID related tests.
Sona Nanotech last traded at $1.18 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.
