31 In addition, the manufac f turing process for any products that we may develop is subj u ect to FDA, EMA and foreign regulatory r authority approval processes and continuous oversight. We will need to contract with manufact f ur t ers who can meet all applicable FDA, EMA and foreign regulatory r authority requirements, including complying with current good manufac f turing practices, or cGMPs, on an on-going basis. If we or our third-party manufact f ur t ers are unabl a e to reliably produce products to specifications acceptabl a e to the FDA, EMA or other regulatory r authorities, we may not obtain or maintain the approvals we need to commercialize such products. Even if we obtain regulatory r approval for any of our product candidates, there is no assurance that either we or our CMOs will be able to manufact f ur t e the approved product to specifications acceptable to the FDA, EMA or other regulatory r authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. For example, our manufact f ur t ers are also engaged in the manufact f ur t ing of vaccines and other therapeutic treatments, and the success of and demand for these vaccines and other therapeutic treatments means we and our programs are competing for scarce manufact f ur t ing resources. We hope to distribute tarcocimab a in a prefille f d syringe early in our commercial rollout. We may not be able to complete our prefill f ed syringe activities in a timely manner, or we may fail technically to design and develop a prefil f led syringe for tarcocimab. a Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization effo f rts, increase our cost of goods, and have an adverse effe f ct on our business, financial condition, results of operations and growth prospects.