Aaahaa#3 ! FINE PRINT - CONNECTING THE DOTS ! Complementing Excellent posts 'Test will be Mfg in the USA' & 'Optimistic Dialog' & 'Hermes Chan Tweet', additionally my previous 'Aahaa #1' & 'Aahaa #2' posts:
*GLEAN the Real World Practical Applications from the FINE PRINT in plain sight -- DO NOT READ like a Newspaper Article
1) 'Tests Mfg in USA':
Webbdx Alabama Assets (assuming manufacturing & production capabilities/facilities) -- "ALABAMA — A Nashville-based company with assets in Alabama has developed a test..."
2) REVEALCOVID-19 PROFESSIONAL USAGE/Emergency Use Approval for Lab's
Allows - Widespread testing (including asymptomatic patients)
Useful in - Follow-up screening, Vaccine Development
Emergency Use Approval for Lab's: special consideration/focus with respect to VACCINE DEVELOPMENT !
MedMira Announces Notification Submission to US FDA Emergency Use Authorization -- "The FDA Policy announced on March 16, 2020 permits Medmira to begin U.S. Sales of REVEALCOVID-19TM total antibody test immediately while it awaits FDA clearance under Emergency Use Authorization (EUA)
MedMira has submitted an Emergency Use Authorization (EUA) application to the United States FDA. At this time, REVEALCOVID-19™ Total Antibody Test application is under review. During the review, however, according to the FDA regulations, MedMira can legally sell and distribute REVEALCOVID-19™ Total Antibody Test to the authorized laboratories in the United States.
Glean '...authorized laboratories in the United States' ! IMHO LAB Vaccine Development - also requires large PPL sample testing!
MedMira plans to pursue these opportunities using its existing internal resources, which include the recently made large product sale. Following this successful agreement Company is able to fulfill the needs of production as well as supply our trusted partners.
*FDA EUA Approval requires passing complex tests conducted by NIH, CDC, BARDA & large real world patient sample sensitivity/specificity data results ! --
In some validation studies of these tests, like the one FDA is conducting in partnership with NIH, CDC, and BARDA, the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests.
** REVEALCOVID-19TM is Great-HEAVENS-to-MEGATRONS BIG ! --
IMHO NO FDA REJECTION at this juncture in time/process implies APPROVAL forthcoming soon ! --
STILL CANNOT CONNECT THE DOTS ? -- have a few glasses of Ur favorite Alcoholic Beverage then Re-Review All ! EtheGreat or Not ?