Biora Therapeutics(BIOR) - 2022 Q4 - Annual Report

36 The initiation and completion of any clinical studies may be prevented, delayed, or halted for numerous reasons. We may experience delays in initiation or completion of our clinical trials for a number of reasons, which could adversely affect the costs, timing, or success of our clinical trials, including related to the following: • we may be required to submit an IDE application to the FDA with respect to our medical device product candidates, which must become effective prior to commencing certain huma ...