Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1357

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1357
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 obtaining coverage and adequate reimbursement may be particularly difficult
because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment
or procedure in which the product is used may not be available, which may impact physician utilization. We cannot be sure that coverage
and reimbursement in the United States, the European Union or elsewhere will be available, or at an acceptable level, for any product
that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Third-party
payors increasingly are challenging prices charged for biopharmaceutical products and services, and many third-party payors may refuse
to provide coverage and reimbursement for particular drugs when an equivalent generic drug or a less expensive therapy is available.
It is possible that a third-party payor may consider our products as substitutable and only offer to reimburse patients for the less
expensive product. Even if we are successful in demonstrating improved efficacy or improved convenience of administration with our products,
pricing of existing drugs may limit the amount we will be able to charge for our products. These payors may deny or revoke the reimbursement
status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize
an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels,
we may not be able to successfully commercialize our products and may not be able to obtain a satisfactory financial return on products
that we may develop.

There
is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States,
third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in
determining the extent to which new drugs will be covered. Some third-party payors may require pre-approval of coverage for new or innovative
devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this
time what third-party payors will decide with respect to the coverage and reimbursement for Decoy20 and any future product candidates.

Obtaining
and maintaining reimbursement status is time-consuming, costly and uncertain. The Medicare and Medicaid programs increasingly are used
as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs. However,
no uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage
and reimbursement