I speculated that previously the FDA said if they got hard data they would approve.
Something about the antigen tests data did not satisfy them. The CITI test is a real world, practical exercise in both getting hard data and real world experience in using the tests. My expectation is using Bella Health as an AI UI to assist the novice testees to operate the test from registration to results will show 'ease of use' as a mitigating factor to aid in the success of the process and give reliable test results that the FDA will approve.