Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 2

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 11
Chunk 2
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 to the clinical hold imposed by the FDA on the study we proposed in our IND for GH001, including our plans and expectations for progressing any nonclinical programs and any other work to lift the clinical hold,
                                                        the timing required to lift such clinical hold and for discussions with the FDA and the outcomes and resolution of such discussions;                                                   
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•   our expectations regarding the size of the eligible patient populations for our GH001 and GH002 product candidates, if approved for commercial use;
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•   our ability to identify third-party clinical trial sites to conduct trials and our ability to identify and train appropriately qualified therapists to administer our investigational therapy;
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•   the effect of pandemics, such as the COVID-19 pandemic, epidemics, outbreaks of an infectious disease or similar events on aspects of our business or operations, including delays in the regulatory approval process, contracting with
                                                                                             clinical trial sites and engaging in clinical trials;                                                                                         
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•   our ability to implement our business model and our strategic plans for our business and GH001 and GH002 product candidates;
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•   our ability to identify, develop or acquire and obtain approval by the FDA, EMA or other comparable foreign regulatory authorities of medical devices required to deliver our GH001 and GH002 product candidates, such as our proprietary
                                                                                                        aerosol delivery device for GH001;                                                                                                   
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•   our commercialization and marketing capabilities and strategy;
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•   the effects of undesirable clinical trial outcomes and potential adverse public perception regarding the use of mebufotenin and psychedelics generally on the regulatory approval process and future development of our product;
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•   the pricing, coverage and reimbursement of our GH001 and GH002 product candidates, if approved;
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•   the scalability and commercial viability of our manufacturing methods and processes;
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•   the rate and degree of market acceptance and clinical utility of our GH001 and GH002 product candidates;
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•   our reliance on third-party suppliers for our nonclinical study, clinical trial drug substance and product candidate supplies, as well as key raw materials used in our manufacturing processes;
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•   our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;
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•   our expectations regarding potential benefits of our GH001 and GH002 product candidates and our approach generally;
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•   our expectations around regulatory development paths and