Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 87

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 87
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 the FDA of an application for marketing approval;  

  satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and  

  FDA review and approval of the drug and drug labeling for marketing.  

Preclinical studies include laboratory evaluation of product chemistry,
toxicity, formulation and stability, as well as animal studies. For preclinical studies conducted in the United States, and certain studies
carried out outside the United States, we submit the results of the nonclinical studies, together with manufacturing information and analytical
results, to the FDA as part of an IND, which must become effective before we may commence human clinical trials.

Clinical Trials (INDs)

Clinical trials involve the administration of the investigational
drug to people under the supervision of qualified investigators in accordance with the principles of good clinical practice, or GCP. We
conduct clinical trials under protocols detailing the trial objectives, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated. We must submit each U. S. study protocol to the FDA as part of an IND. An IND will automatically become effective
30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct of the
trials as outlined in the IND. In such a case, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions before
clinical trials can proceed. Submission of an IND does not always result in the FDA allowing clinical trials to commence and the FDA may
halt a clinical trial if unexpected safety issues surface or the study is not being conducted in compliance with applicable requirements.

The FDA may refuse to accept an IND for review if applicable regulatory
requirements are not met. Moreover, the FDA may delay or prevent the start of clinical trials if the manufacturing of the study drug fails
to meet cGMP requirements or the clinical trials are not adequately designed. Such government regulation may delay or prevent the study
and marketing of potential products for a considerable time period and may impose costly procedures upon a manufacturer’s activities.
In addition, the FDA may, at any time, impose a clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold, clinical
trials cannot continue without FDA authorization and then only under terms authorized by the FDA.

Success in early-stage clinical trials does not assure success
in later-stage clinical trials. Results obtained from clinical activities are not always conclusive and may be susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. Even