Biovica announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica's 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica's submission. In October 2020, the FDA informed Biovica that its handling of a large number of Emergency Use Authorization (EUA) requests for in vitro diagnostics (IVDs) to address COVID19 implied a reallocation of resources impacting the timeline for completion of the review of Biovica's submission. At the time, the FDA estimated that the reallocation would last approximately 90 days. Due to the sustained volume of EUA requests the FDA has now informed Biovica that it is not yet able to resume the review of Biovica's submission. The FDA currently estimates that the reallocation will last annother 90 days, approximately, but continues to state that the precise duration is not known due to the uncertainty associated with the pandemic, including the volume of future IVD EUA requests the FDA may receive. Biovica will continue to receive monthly updates regarding the anticipated timeline for reallocation of resources back to nonCOVID related activities and resumption of the submission review. When the FDA resumes the review, Biovica will provide an estimated time for completing the review.