Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 5

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 5
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 our (potential future) collaboration partners’ failure to obtain regulatory approval to market GLPG5101, GLPG5301, GLPG3667 and/or other product candidates, which would harm our business, results of operations and prospects significantly. In addition, even if we were to obtain additional approvals, regulatory authorities may approve any of our products or product candidates for fewer or more limited indications or patient populations than we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product or product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. In certain jurisdictions, 

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regulatory authorities may not approve the price we intend to charge for our products. Any of the foregoing scenarios could materially harm the commercial prospects for our products or product candidates.
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Additionally, in the past and for future planned clinical trials, we may utilize, an “open-label” trial design. In an open-label trial, both investigators and trial participants are fully aware of which treatment group the participants are in and what treatments are assigned to them. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates when studied in a controlled environment with a placebo or active control.
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In addition, we cannot guarantee that the FDA, EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authority will interpret the results of any of our ongoing or planned clinical trials as we do, and additional clinical trials beyond those we anticipate conducting could be required before we can submit our product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA, EMA, the MHRA, the MHLW/PMDA or any comparable regulatory authority to support a