The primary endpoint for the trial was time to CRBSI. We expect to be able to complete this requirement expeditiously. An indication for use in total parenteral nutrition was also approved. The clinical trial process for a new compound can take ten years or more to complete. In this event, the application must be resubmitted with the additional information. This hypothesis must be demonstrated to obtain orphan drug exclusivity. The number and scope of these requirements can be complex and could increase. The warrants expired during the year ended December 31, 2020. 5.Successful development and commercialization of our other products is uncertain. 14.Even if approved, our products will be subject to extensive post-approval regulation. 5.We may not successfully manage our growth. 5.We rely on third parties to conduct our clinical trials and pre-clinical studies. This has resulted in lower rates of reimbursement. We may not successfully manage our growth. Our commercial success will depend in part on the maintenance of our license agreements. 9,339,036 (expiring November 2, 2024); ●U.S. Patent No. Furthermore, the necessary licenses may not be available on satisfactory terms or at all. The Company filed an appeal against the ruling on September 7, 2016. Replacement collaborators might not be available on attractive terms, or at all.