Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 90

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 90
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 compliance with regulatory standards for manufacturing and quality control are not maintained or
if additional safety problems are identified following initial marketing.

If the FDA’s evaluation of the NDA or BLA submission or manufacturing
processes and facilities is not favorable, the FDA may refuse to approve the NDA or BLA and may issue a complete response letter. The
complete response letter, or CRL, indicates that the review cycle for an application is complete and that the application is not ready
for approval. The complete response letter will describe specific deficiencies and, when possible, will outline recommended actions the
applicant might take in order to place the application in condition for approval. Following receipt of a CRL, the company may submit additional
information and start a new review cycle, withdraw the application or request a hearing. Failure to take any of the above actions may
result in the FDA considering the application withdrawn following one year from issuance of the CRL. In such cases, the FDA will notify
the company and the company will have 30 days to respond and request an extension of time in which to resubmit the application. The FDA
may grant reasonable requests for extension. If the company does not respond within 30 days of the FDA’s notification, the application
will be considered withdrawn. Even with submission of additional information for a new review cycle, the FDA ultimately may decide that
the application does not satisfy the regulatory criteria for approval.

49

The Pediatric Research Equity Act, or PREA, requires NDAs and BLAs
(or supplements) for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration to contain
results assessing the safety and efficacy for the claimed indication in all relevant pediatric subpopulations. Data to support dosing
and administration also must be provided for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant
deferrals for the submission of results or full or partial waivers from the PREA requirements (for example, if the product is ready for
approval in adults before pediatric studies are complete, if additional safety data is needed, among others). In addition, under the Best
Pharmaceuticals for Children Act, or BPCA, the FDA may issue a written request to the company to conduct clinical trials in the pediatric
population that are related to the moiety and expand on the claimed indication. The studies are voluntary but may award the company with
6 months of marketing exclusivity if conducted according to good scientific principles and address the written