Therma Bright Inc V.THRM

Health Canada Trails 300 participants…

[Mole101]

The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared. The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/list-authorized-trials.html

[Dude51]

Old News? Study Type  : Observational Estimated Enrollment  : 300 participants Observational Model: Cohort Time Perspective: Retrospective Official Title: POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva Estimated Study Start Date  : May 15, 2021 Estimated Primary Completion Date 

[Mole101]

Finally approved to go ahead as of the 16/09/2021   Show 102550100 entries Trial Name /Protocol #/control # Title Medical device name Authorization holder Authorization date Clinicaltrials.gov Link ITA #329700 Authorized under Clinical Trials Interim Order POC Study to Evaluate

[Mole101]

Sep 17, 2021 - in Pediatric Emergency Departments ID NOW COVID-19 The Governors of the University of Calgary 2021-09-03 NCT05040763 ITA #329700 Authorized under Clinical Trials Interim Order POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva COVID-19 Rapid Antigen Test Therma Bright Inc. 2021-09-16

[forrest6748]

Am I missing something ? Can anybody clarify what Health Canada is doing? Request for a test in May 2021, test in Brazil with positive results and application for approval in August. Oups!!! they just wake up and the gave the go head for the trial last Friday..... The approval is going to be delayed for a while. I just hope that the FDA is smarther than HC. If I was in charge of the department,

[hk1966]

Amen to that and a boot in the a$$. HC is unbelievably slow in following up on anything but hey that could be a ploy to cry the blues to the feds for more money because a pandemic is a terrible thing to go to waste.

[terr2]

Thanks to Health Canada the open today will be very bad.

[mooseslayer]

Markets are down

[stockmonster6]

Well, isn't that interesting?  Good find!  There wasn't a news release on that. From the my former research on HC, this should be completed in 30 days or less. Once that internal test is done, approvals.