Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 224

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 224
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 1, Phase 2 and Phase 3 clinical trials are subject to a clinical trial application (CTA) for each phase of study. Furthermore, in
Canada, Health Canada or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that
the research subjects are being exposed to an unacceptable health risk. Similarly, an REB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the REB’s requirements or if the drug has
been associated with unexpected serious harm to subjects. Additionally, some clinical trials are overseen by an independent group of qualified
experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group regularly reviews accumulated
data and advises the study sponsor regarding the continuing safety of trial subjects, potential trial subjects and the continuing validity
and scientific merit of the clinical trial. We may also suspend or terminate a clinical trial based on evolving business objectives or
competitive climate.

New Drug Submission (NDS)

Upon successful completion
of Phase 3 clinical trials, in Canada the company sponsoring a new drug then assembles all the preclinical and clinical data and other
testing relating to the product’s pharmacology, chemistry, manufacture, and controls, and submits it to Health Canada as part of
a New Drug Submission, or NDS. The NDS is then reviewed by Health Canada for approval to market the drug.

As part of the approval process,
an additional application for a Drug Establishment License (DEL) 90 days prior the NDS submission to Health Canada to initiate review
and inspection of the facility or the facilities at which the drug is manufactured are compliant with GMP requirements. Health Canada
will not approve the product unless compliance with cGMP—a quality system regulating manufacturing—is satisfactory and the
NDS contains data that provide substantial evidence that the drug is safe and effective in the indication studied. In addition, before
approving an NDS, Health Canada will typically inspect one or more clinical sites to assure compliance with GCP.

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The testing and approval process
for an NDS requires substantial time, effort and financial resources, and may take several years to complete. Data obtained from preclinical
and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent
regulatory approval. Health Canada may not grant approval of an NDS on a timely basis, or at all