Post by
Lagrenouille on Sep 21, 2020 9:08am
FDA COVID test submission approval rate
Just out of curiosity I went through the COVID tests list of approved and pending submission. Most are PCR, serological, 2 antigens one being SONA.
The site is: https://www.360dx.com/coronavirus-test-tracker-launched-covid-19-tests
I added the monthly approved submissions, March:22, April:48, May:36, June:53, July:37
August:38, September:13 so far, 29 are pending.
My point is to have an idea of FDA activity on these submission. We can see that they have been active. Sona has provided them all the required information and more than needed.
I do not see how their submission could be delayed any further and this week should be the one we wait for... This is my guess and greatest hope for all!
GLTA
Comment by
MilanoBiscuits on Sep 21, 2020 9:18am
could you please provide a HC link that states sonas antigen test is under review. i have tried to access the site but could not locate their submission to HC
Comment by
TraderWannaBe on Sep 21, 2020 9:19am
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/applications.html#wb-auto-4 Page 8
Comment by
MilanoBiscuits on Sep 21, 2020 9:22am
now i can sleep easy tonight thank you sir!