EUA 201403 - update: on 9/17/2020, denied by FDA due to "concerns of inadequate data deficiencies and clinical performance". We submitted in March and was finally reviewed with feedback given after almost half year! Fact is that we submitted according to the policy then and the policy has changed! We submitted to NCI for indepedent validation in early July once we got to know this wonderful program, but when we asked for results after our submission, NCI replied that they do not give us their test result by stating that only FDA is responsible for giving us the result, and FDA told us NCI has not given result to them yet. Obviously FDA denied this EUA application without NCI's input. We assumed that NCI's independent validation is designed to help FDA get adequeate data to support the new policy and updated data on clinical performance. Now that we know our assumption is wrong, We are working on resoloving this by working with FDA. Please stay tuned.
--- FDA listing
FDA Notification path granted on 4/23/2020