Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 238

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 238
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 conducted
in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to subjects.

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Concurrent with clinical trials,
companies usually complete additional preclinical studies and must also develop additional information about the chemistry and physical
characteristics of the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product drug and, among other things, the manufacturer
must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging
must be selected and tested and stability studies must be conducted to demonstrate that the product drug does not undergo unacceptable
deterioration over its shelf life.

The results of product development,
non-clinical studies and clinical trials, together with other detailed 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