Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 8

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 8
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 or biologics. The FDA’s regulatory authority for the approval of biologics resides
in the PHS Act. However, biologics are also subject to regulation under the FDCA because most biological products also meet the FDCA’s
definition of “drugs.” Most pharmaceuticals or “conventional drugs” consist of pure chemical substances and their
structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products
differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination, thus requiring sterile
manufacturing processes. The process required by the FDA before biologic product candidates may be marketed in the United States generally
involves the following:

·completion of preclinical laboratory tests and
animal studies performed in accordance with the FDA’s current Good Laboratory Practices regulations;

·submission to the FDA of an IND which must become
effective before human clinical trials may begin and must be updated annually;

·approval by an independent Institutional Review
Board (“IRB”) ethics committee at each clinical site before the trial is initiated;

·performance of adequate and well-controlled clinical
trials to establish the safety, purity and potency of the proposed biologic, and its safety and efficacy for each indication;

·preparation of and submission to the FDA of a
Biologics License Application (“BLA”) for a new biologic, after completion of all pivotal clinical trials;

·satisfactory completion of an FDA Advisory Committee
review, if applicable;

·a determination by the FDA within 60 days of
its receipt of a BLA to file the application for review;

·satisfactory completion of an FDA pre-approval
inspection of the manufacturing facilities to assess compliance with current Good Manufacturing Practice (“cGMP”) regulations; and

·FDA review and approval of a BLA for a new biologic,
prior to any commercial marketing or sale of the product in the United States.

Preclinical tests assess the potential safety and
efficacy of a product candidate in animal models. Clinical trials involve the administration of the investigational product to human subjects
under the supervision of qualified investigators in accordance with current Good Clinical Practices (“cGCPs”), which include
the requirement that all research subjects provide their informed consent for their participation in any clinical trial. A protocol for
each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. Additionally, approval must
also be obtained from each clinical trial site