Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 19

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 19
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 certain regulatory bodies or industry professionals, or if such protocols are later found to be ineffective, may require us or our collaboration partners to change the design of our clinical trials.

In connection with clinical trials of our product candidates, we face a number of risks, including risks that:

  we or our collaboration partners may be unable to manufacture or obtain sufficient quantities of qualified materials for clinical trials or may be required to modify manufacturing processes;  
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  patient recruitment may be slower than expected and we may have difficulty accessing potential clinical trial sites;  
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  a product candidate may be ineffective, inferior to existing approved products for the same indications, unacceptably toxic or have unacceptable side effects;  
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  patients may die or suffer other adverse effects for reasons that may or may not be related to the product candidate being tested;  
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  a clinical trial may be delayed, suspended or terminated by the institutional review board or ethics committee responsible for overseeing the clinical trial, by regulatory authorities or by us ...  
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  investigators or other third parties could conduct clinical trials on our products or product candidates that could lead to adverse events or results that could negatively impact the developmen...  

  extension trials on long-term tolerance could invalidate the use of our product;  

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  clinical trials may not demonstrate statistically sufficient levels of safety and efficacy to obtain the requisite regulatory approvals;  
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  even if data is sufficient for regulatory approval, it may not be sufficient to secure pricing reimbursement or to secure validation of our products by key industry players, which could delay o...  
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  our collaboration partners or CROs may be unable or unwilling to perform under their contracts.  
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