Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 135

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 135
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 information regarding the manufacturing process, analytical tests
conducted on the product, proposed labeling and other relevant information, are submitted to the FDA as part of an NDA requesting approval
to market the new drug. The FDA reviews all NDAs submitted within 60 days of submission to ensure that they are sufficiently complete
for substantive review before it accepts them for filing. If the submission is accepted for filing, the FDA begins an in-depth substantive
review.

The approval process is lengthy
and difficult and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional
clinical data or other data and information. Even if such data and information are submitted, the FDA may ultimately decide that the NDA
does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive, and the FDA may interpret data
differently than we interpret the same data. The FDA will issue a complete response letter if the agency decides not to approve the NDA
in its present form. The complete response letter usually describes all of the specific deficiencies that the FDA identified in the NDA
that must be satisfactorily addressed before it can be approved. The deficiencies identified may be minor, for example, requiring labeling
changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended
actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued, the
applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application or request
an opportunity for a hearing.

If after such review a product
receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may
otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications,
warnings or precautions be included in the product labeling. Any products for which we receive the FDA approval would be subject to continuing
regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product,
providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain
electronic records and signature requirements and complying with the FDA promotion and advertising requirements. In addition, the FDA
may require post-approval studies, including Phase 4 clinical trials, to further assess a product’s safety and effectiveness after