Estimated Timeline ....Based on the Dec 7 news release and the youtube video:
News release:
Therma will procure up to 300 prototype tests from one of its suppliers to undertake initial testing with selected sites in Ontario. The initial testing of the CoviSafe™ test will be for symptomatic patients. Therma is working with Public Health Ontario to identify sites in the Province to conduct preliminary testing and evaluation of CoviSafe™. Testing is expected to start before year end, but because of potential delays due to the holidays, may extend into January.
As the CoviSafe™ test's performance is validated in symptomatic patients, it will be rolled out as a screening test for monitoring large populations of healthy individuals that are asymptomatic for illness. Therma Bright has received a request to perform the asymptomatic testing in the workplace with a national business with thousands of employees across Canada. The goal is to provide our solution for routine and widespread testing at home, and in schools, workplaces, sporting events and other venues where a rapid result is required.
Once testing is complete and a minimum set with 300 samples data will be compiled and sent to both FDA and Health Canada for approval under EUA with FDA and the Interim Order with Health Canada. The Company expects to submit data to both regulatory agencies in early 2021. Therma Bright and its partners have initiated discussions with manufacturers of the test with a focus on scaling production on a commercial scale for worldwide distribution.
in the you tube video Rob stated that to get the products to market would take 4-6 months and that was 2 mos ago.
As a Transformation Manager myself, I understand the headaches and process attributed to runtime and deliverables. It seems they still need the prototypes, the locations and the coordination for these activities. The logistics and planning needs to take place. Realistically, 300 tests can be completed in 1-3 days. The processing would take place over a week and the asympomatic testing kits should have been ordered and distributed at or near the same time as the initialized tests. Now, I did read in another presser that symptomatic tests would be completed in a setting with actual infections (hospital/nursing homes I assume). All of this data will take time to collect and asses/verify accuracy to tests that lab results of 100% currently being used.
The application process then needs to occur with the FDA and HC. This, may take 2-4 weeks. This is in line with Rob's timeline of 4 months with padding a few weeks in cases of delays (holidays/access/test subjects) taking the holidays into account.
As for news releases, I can see the next one being that the prototypes have been procured and a timeline for site selection completed.
Asympomatic sites (major company to work with) I would think would be involved with health care maybe VON or a service that delivers home services related to healthcare. These are just my opinions, but that would be a Project Plan I would be working with if managing the resources and dependancies.
sorry for any typos... doing this on my phone!