Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 9

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 9
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’s IRB before the trials may be initiated, and the IRB must monitor the study until
completed. There are also requirements governing the reporting of ongoing clinical trials and clinical trial results to public registries.

 5 

The clinical investigation of a pharmaceutical, including
a biologic, is generally divided into three phases followed by potential post-market obligations. Although the phases are usually conducted
sequentially, they may overlap or be combined.

·Phase I studies are designed to evaluate the
safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with
increasing doses, and if possible, to gain early evidence on effectiveness.

·Phase II includes controlled clinical trials
conducted to preliminarily or further evaluate the effectiveness of the investigational product for a particular indication(s) in patients
with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects
and safety risks associated with the product.

·Phase III clinical trials are generally controlled
clinical trials conducted in an expanded patient population generally at geographically dispersed clinical trial sites, and are intended
to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational
product, and to provide an adequate basis for product approval.

·Phase IV clinical trials may be required to as
post-marketing studies to find out more about the product’s long-term risks, benefits, and optimal use, or to test the drug in different
populations.

The FDA may place clinical trials on hold at any point
in this process if, among other reasons, it concludes that clinical subjects are being exposed to an unacceptable health risk. Trials
may also be terminated by IRBs, which must review and approve all research involving human subjects. Side effects or adverse events that
are reported during clinical trials can delay, impede or prevent marketing authorization.

The results of the preclinical and clinical testing,
along with information regarding the manufacturing of the product and proposed product labeling, are evaluated and, if determined appropriate,
submitted to the FDA through a BLA. The application includes all relevant data available from pertinent preclinical and clinical trials,
including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s
chemistry, manufacturing, controls and proposed labeling, among other things.  Once the BLA submission has been accepted for filing,
the FDA’s standard goal is to review applications within ten months of the filing date or, if the