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Risks Related to the Clinical Development and Regulatory Approval of Our Product Candidates
If we or our partners do not obtain regulatory approval for our current and future product candidates, our business will be adversely affected.
Our product candidates are and will be subject to extensive governmental regulations relating to, among other things, development,
clinical trials, manufacturing and commercialization. In order to obtain regulatory approval for the commercial sale of any product candidates, we or our partners must demonstrate through extensive
preclinical studies and clinical trials that the product candidate is safe and effective for use in each target indication. Clinical testing is expensive, time-consuming and uncertain as to outcome.
We or our partners may gain regulatory approval for VTP-34072, VTP-37948, VTP-43742, VTP-38443, VTP-38543, or other future product candidates in some but not all of the territories available or some
but not all of the target indications,
resulting in limited commercial opportunity for the approved product candidates, or we or they may never obtain regulatory approval for these product candidates.
Delays in the commencement, enrollment or completion of clinical trials of our product candidates could result in increased costs to us as well as a delay or failure in
obtaining regulatory approval, or prevent us from commercializing our product candidates on a timely basis, or at all.
We cannot guarantee that clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more
clinical trials can occur at any stage of testing. Events that may prevent successful or timely commencement, enrollment or completion of clinical development
- delays by us or our partners in reaching a consensus with regulatory agencies on trial design;
- delays in reaching agreement on
acceptable terms with prospective clinical research organizations, or CROs, and clinical
- delays in obtaining required Institutional Review Board, or IRB, approval at each clinical trial site;
in recruiting suitable patients to participate in clinical trials;
- imposition of a clinical hold by regulatory agencies for any reason, including safety concerns or after an inspection
clinical operations or trial sites;
- failure by CROs, other third parties or us or our partners to adhere to clinical trial requirements;
- failure to perform in accordance with the FDA's good clinical practices, or GCP, or applicable regulatory guidelines in
- delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;
- delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;
- clinical trial sites or patients dropping out of a trial;
- occurrence of serious adverse events in clinical trials that are associated with the product candidates that are viewed to
outweigh its potential benefits; or
- changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
including delays caused by the above factors, can be costly and could negatively affect our or our partners' ability to complete a clinical trial. If we or our partners are not
able to successfully complete clinical trials, we will not be able to continue development, obtain regulatory approval or commercialize our product candidates. We currently do not hold any active
investigational new drug, or IND, applications or clinical trial authorizations and are reliant at this time entirely upon BI for conduct of clinical trials for our two partnered product candidates.