RE:what is taking so longFirst : Prior to the Company’s regulatory submission in August, no guidelines existed on performance criteria or clinical data requirements for rapid antigen tests in Canada !
Second : Any trial of an unapproved medical device in Canada requires a sponsor institution, a principal investigator, a study protocol, relevant medical ethics review board (IRB/REB) approval and then Health Canada Investigational Testing Division approval before a study can commence. The Company is currently working with an institution in Canada to secure IRB approval with a view to conducting a large-scale clinical study of the Company’s saliva test for COVID-19
Tercio: They did trial on more than 30 !! e SaudiVax conducted a medical ethics review board approved clinical trial of Sona’s test with 99 subjects in the summer of 2020view board (IRB/REB) approval and then Health Canada Investigational Testing Division approval before a study can commence. The Company is currently working with an institution in Canada to secure IRB approval with a view to conducting a large-nkkkcnv clrtinical study of the Company’s saliva test for COVID-19.