AKAO 2017 Annual Report

41 We may also be required to sell or license to others technologies or clinical product candidates or programs that we would prefer to develop and commercialize ourselves. Clinical drug development involves a lengthy and expensive process with uncertain outcomes that may lead to delayed timelines and increased cost, and may prevent us from being able to complete clinical trials. Clinical testing is expensive, can take many years to complete, and its outcome and timeline is inherently uncertain. The results of preclinical and clinical studies of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies, and we cannot be certain that we will not face similar setbacks. We submitted a NDA for plazomicin in October 2017, which was accepted by the FDA in January 2018. We plan on a commercial launch of plazomicin in the U.S. in 2018, if our NDA is approved. We also plan to submit a MAA to the EMA for plazomicin in 2018. Based on physician market research, we believe the Phase 3 CARE study will provide important and meaningful data regarding the efficacy, safety, microbiology, and dosing, as well as important health economic data, to better inform use of plazomicin in the treatment of patients with CRE infections. We cannot be certain that our future clinical trials for plazomicin, C-Scape, or other product candidates, will progress as expected, not need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all, or support continued clinical development of the associated product candidate. Clinical trials can be delayed, aborted or fail for a variety of reasons, including delay or failure: • to obtain regulatory approval to commence a trial in the countries where the trial is to be conducted; • to successfully initiate a clinical trial, enroll patients, and complete clinical trial activities in foreign countries; • to recruit and enroll suitable patients to participate in a trial; • to reach agreement on acceptable terms with prospective contract research organizations (“CROs”) or clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • to obtain institutional review board (“IRB”) approval at each site; • to have patients complete a trial or return for post-treatment follow-up; • of clinical sites to adhere to trial protocols or continue to participate in a trial; • to address any patient safety concerns that arise during the course of a trial; • to address any conflicts with new or existing laws or regulations; • to add a sufficient number of clinical trial sites; • to manufacture sufficient quantities of product supply for use in clinical trials; or • to ensure clinical trial sites comply with Good Clinical Practice (“GCP”) guidelines. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, slow down or halt our product development and approval processes, and jeopardize our ability to commence product sales and generate revenue, which would cause the value of our company to decline and limit our ability to obtain additional financing if needed. Patient enrollment in clinical trials is a function of many factors, including: the nature