Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 57

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 57
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 earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”) approvals for such products
more rapidly than we will, or in developing products that are more effective than products we propose to develop. While we will seek to
expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others
will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop,
or that any therapy we develop will be preferred to any existing or newly developed technologies.

We may request priority review for our product
candidate in the future. The FDA may not grant priority review for our product candidate. Moreover, even if the FDA designates such product
for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, would not assure
FDA approval.

We may be eligible for priority
review designation for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides
a treatment where no adequate therapy exists. A priority review designation means that the goal for the FDA is to take action on an application
in six months, rather than the standard review period of ten months. The FDA has broad discretion with respect to whether or not to grant
priority review status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or
status, the FDA may decide not to grant it. Thus, while the FDA has granted priority review to other oncology disease products, our product
candidate, should we determine to seek priority review, may not receive similar designation. Moreover, even if our product candidate is
designated for priority review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer
any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does not guarantee
approval within an accelerated timeline or thereafter.

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We believe we may in some instances be able
to secure approval from the FDA or comparable non-U.S. regulatory authorities to use accelerated development pathways. If we are unable
to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate,
which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.

We anticipate that we may
seek an accelerated approval pathway for our product candidates. Under the accelerated approval provisions in the Federal Food, Drug,
and Cosmetic Act, or FDCA, and the FDA’s