Read this very well guysHave faith, we waited more than 1 year already! sharks are still surrounding us, all cards are on deck, what is one more week if we need to wait? Read Tony's comment below:
@TonyTwoShoes FROM DEC 1st Per the new guidance: "Specifically, at this stage of the pandemic, the FDA intends to focus its review on EUA requests for the following types of tests; Diagnostic tests (molecular and antigen) that can be used at the POC or completely at home, from developers who have indicated the ability to scale up manufacturing capacity to 500,000 tests per week within 3 months of authorization." In addition to the new manufacturing partner, Therma Bright has already secured other manufacturers in three markets - Southeast Asia, Mexico and Canada - to produce over 500,000 AcuVid™ tests per month. The Company's total production capacity from all four manufacturing partners now represents a production capacity of a minimum of 2.5 million AcuVid™ tests per month. "We're excited to add a new manufacturing partner to our Therma Bright team; one who alone can help us meet the minimum 500,000 weekly production requirement per the November 15, 2021 FDA guidance for Covid-19 antigen diagnostic tests developers," expressed Rob Fia, CEO of Therma Bright. "We have provided the FDA with the new manufacturing agreement to comply with their latest guidance around production, as we await the final results from our U.S. clinical performance study being conducted at three Covid-19 testing clinics."