Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 22

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 22
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 benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative
treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled
confirmatory clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical
benefit, and may require that such confirmatory studies be underway before granting any accelerated approval. Products receiving accelerated
approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required confirmatory studies in a timely
manner or if such studies fail to verify the predicted clinical benefit. In addition, the FDA currently requires as a condition for accelerated
approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Fast
track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval
but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later
decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will
not be shortened. We may explore some of these opportunities for our product candidates as appropriate.

Orphan
drug designation

Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which
is a disease or condition that affects fewer than 200,000 individuals in the United States or, if it affects more than 200,000 individuals
in the United States, there is no reasonable expectation that the cost of developing and making a drug product available in the United
States for this type of disease or condition will be recovered from sales of the product. Orphan designation must be requested before
submitting an NDA or BLA. After the FDA grants orphan designation, the identity of the therapeutic agent and its potential orphan use
are disclosed publicly by the FDA. Orphan designation does not convey any advantage in or shorten the duration of the regulatory review
and approval process.

If
a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such
designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to
market the same drug or biologic for the same disease or condition for seven years, except in limited circumstances, such as a showing
of