Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 37

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 37
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 Good Manufacturing Practice, or cGMP, regulations; and

    ●
    FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

The testing and approval process
requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will
be granted on a timely basis, if at all.

Preclinical tests include
laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals and other animal
studies. The results of preclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND
to the FDA. Some preclinical testing may continue even after an IND is submitted. The IND also includes one or more protocols for the
initial clinical trial or trials and an investigator’s brochure. An IND automatically becomes effective 30 days after receipt by
the FDA, unless the FDA, within the 30-day time period, raises concerns or questions relating to the proposed clinical trials as outlined
in the IND and places the clinical trial on a clinical hold. In such cases, the IND sponsor and the FDA must resolve any outstanding concerns
or questions before any clinical trials can begin. Clinical trial holds also may be imposed at any time before or during studies due to
safety concerns or non-compliance with regulatory requirements. An independent institutional review board, or IRB, at each of the clinical
centers proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center.
An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in
relation to anticipated benefits. The IRB also approves the consent form signed by the trial participants and must monitor the study until
completed.

The FDA offers several regulatory
mechanisms that provide expedited or accelerated approval procedures for selected drugs in the indications on which we are focusing our
efforts. These include accelerated approval under Subpart H of the agency’s NDA approval regulations, fast track drug development
procedures and priority review.

22

The United States, European
Union and other jurisdictions may grant orphan drug designation to drugs intended to treat a “rare disease or condition,”
which, in the United States, is generally a disease or condition that affects no more than 200,000 individuals. In the European Union,
orphan drug designation can be granted if: the disease is life threatening or chronically debilitating and