Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 42

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 42
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New Drug Applications

Assuming successful completion
of the required clinical trials, the results of product development, preclinical studies and clinical trials are submitted to the FDA
as part of an NDA. An NDA also must contain extensive manufacturing information, as well as proposed labeling for the finished product.
An NDA applicant must develop information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing
the product in accordance with cGMP. The manufacturing process must be capable of consistently producing quality product within specifications
approved by the FDA. The manufacturer must develop methods for testing the quality, purity and potency of the final product. In addition,
appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product does not undergo
unacceptable deterioration over its shelf life. Prior to approval, the FDA will conduct an inspection of the manufacturing facilities
to assess compliance with cGMP.

The FDA reviews all NDAs submitted
before it accepts them for filing. The FDA may request additional information rather than accept an NDA for filing. In this event, the
NDA must be resubmitted with the additional information and is subject to review before the FDA accepts it for filing. After an application
is filed, the FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should
be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it considers them carefully
when making decisions. The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied. Data obtained from
clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA may issue
a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order to
secure final approval of the NDA. If a product receives regulatory approval, the approval may be significantly limited to specific diseases
and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition,
the FDA may require us to conduct Phase 4 testing which involves clinical trials designed to further assess a drug’s safety and
effectiveness after NDA approval and may require surveillance programs to monitor the safety of approved products which have been commercialized.
Once issued, the FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety or efficacy questions are
raised after the product reaches the market.

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