Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 134

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 134
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  Phase 2. Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients...  

  Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2, and ar...  
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Progress reports detailing
the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and
clinical investigators within 15 calendar days for serious and unexpected suspected adverse events, any clinically important increase
in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings
from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug candidate. Additionally,
a sponsor must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction no later than 7 calendar days after
the sponsor’s receipt of the information. There is no assurance that Phase 1, Phase 2 and Phase 3 testing can be completed successfully
within any specified period, or at all. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds,
including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend
or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
requirements or if the product has been associated with unexpected serious harm to subjects.

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