Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 574

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 574
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 Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture
and marketing of regulated products or the reimbursement thereof. In addition, the FDA may change its clearance and approval policies,
adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of
our future products under development or impact our ability to modify our currently cleared products on a timely basis. Any new regulations
or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products.
It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what
the impact of such changes, if any, may be.

FDA regulations and guidance are
often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new statutes, regulations
or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products
or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products. We cannot determine what
effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our
business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance or approval;
changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record keeping.

The FDA’s and comparable
foreign regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent,
limit or delay certification, regulatory clearance or approval of our product candidates. We cannot predict the likelihood, nature or
extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. For example,
the results of the upcoming mid-term Congressional elections may impact our business and industry. Any change in the laws or regulations
that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and
costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in
receiving clearance or approval or the failure to receive clearance or approval for any new products would have an adverse effect on our
ability to expand our business. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements
or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing clearance that