Company: CRVO
Filing Date: 2025-03-17
Form Type: 10-K
Source: 0001437749-25-007829
Chunk: 58

Company: CervoMed Inc.
Filing Date: 2025-03-17
Form: 10-K
Item: Item 1A
Chunk 58
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 the Company or others identify undesirable side effects caused by such product candidates (or any other similar products) after such approval, a number of potentially significant negative consequences could result, including:

  regulatory authorities may withdraw or limit their approval of such product candidates;  
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  regulatory authorities may require the addition of labeling statements, such as a “ Boxed” Warning or a contraindication;  
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  the Company may be required to change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates;  
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  the FDA may require a REMS plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,...  
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  the Company may be subject to regulatory investigations and government enforcement actions;  
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  the FDA or a comparable foreign regulatory authority may require the Company to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and ef...  
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  the Company may decide to recall such product candidates from the marketplace after they are approved;  
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  the Company could be sued and held liable for injury caused to individuals exposed to or taking its product candidates; and  

  the Company’s reputation may suffer.  
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The Company may be unable to obtain regulatory approval in the U. S. or foreign jurisdictions and, as a result, be unable to commercialize its product candidates and its ability to generate revenue will be materially impaired.

The time required to obtain FDA and other approvals is unpredictable but typically takes many years following the commencement of clinical trials, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when regulating companies such as ours are not