Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 20

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 20
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The FDA may not accept data from trials we or our collaboration partners conduct outside the U. S. or may require additional U. S.-based trials as a condition of regulatory approval.

We and our collaboration partners have conducted, currently are conducting and intend in the future to conduct clinical trials outside the U. S., including in the EU where we are headquartered. Although the FDA may accept data from clinical trials conducted outside the U. S., acceptance of this data is subject to certain conditions imposed by the FDA, including with respect to compliance with cGCPs and applicability of the data to the U. S. population and U. S. medical practice in ways that the FDA deems clinically meaningful. If the FDA does not accept the data from any clinical trials that we or our collaboration partners conduct outside the U. S., it would likely result in the need for additional clinical trials, which would be costly and time-consuming and delay or permanently halt our ability to develop and market these product candidates for the proposed indications in the U. S. In other jurisdictions, for instance, in Japan, there is a similar risk regarding the acceptability of clinical trial data conducted outside of that jurisdiction.

We or our collaboration partners may encounter difficulties enrolling patients in our clinical trials.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We or our collaboration partners may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

  the size and nature of the patient population;  

  the patient eligibility criteria defined in the protocol;  

  the size of the trial population required for analysis of the trial’s primary endpoints;  

  the proximity of patients to trial sites;  

  the design of the trial;  

  our ability to recruit clinical trial investigators with the appropriate competencies and experience;  

  competing clinical trials for similar therapies or other new therapeutics not involving our product candidates and/or related technologies;  

  clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or...  
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  our ability to obtain and maintain patient consents; and  

  the risk that patients enrolled in clinical trials will not complete a clinical trial.