Known risk factors include the following the FDA may not approve the BLA for SRP9001 by the application PDUFA date or at all we may not be able to comply with all FDA requests including with respect to our SRP9001 BLA in a timely manner or at all the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business as well as the development of our product candidates and our financial and contractual obligations our dependence on certain manufacturers to produce our products and product candidates including any inability on our part to accurately anticipate product demand and timely secure manufacturing capacity to meet product demand may impair the availability of product to successfully support various programs our data for SRP9001 may not be sufficient for obtaining regulatory approval success in preclinical and clinical trials especially if based on a small patient sample does not ensure that later clinical trials will be successful and the results of future research may not be consistent with past positive results or with advisory committee recommendations or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates the commencement and completion of our clinical trials and announcement of results may be delayed or prevented for a number of reasons including among others denial by the regulatory agencies of permission to proceed with our clinical trials or placement of a clinical trial on hold challenges in identifying recruiting enrolling and retaining patients to participate in clinical trials and inadequate quantity or quality of supplies of a product candidate or other materials necessary to conduct clinical trials different methodologies assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results and even if we believe the data collected from clinical trials of our product candidates are positive these data may not be sufficient to support approval by the FDA or other global regulatory authorities we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines research and clinical development plans and bringing our product candidates to market for various reasons many of which may be outside of our control including possible limitations of company financial and other resources manufacturing limitations that may not be anticipated or resolved for in a timely manner regulatory court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates and the ongoing COVID19 pandemic and those risks identified under the heading Risk Factors in our most recent Annual Report on Form 10K for the year ended December 31 2022 and Form 10Q filed with the Securities and Exchange Commission SEC as well as other SEC filings made by the Company which you are encouraged to review