Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 58

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 58
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 implementing regulations, the FDA may grant accelerated approval to a product designed
to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination
that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical
benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given
disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such
as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not
itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect
on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other
clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may
not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted,
accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval
confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s
clinical benefit, the FDA may withdraw its approval of the drug.

Prior to seeking such accelerated
approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval. There
can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application,
or NDA, for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance
that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development,
review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval
or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission
or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The
FDA or other non-U.S. authorities could also require us to conduct further studies prior to considering our application or granting approval
of any type