Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1337

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1337
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 we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to
resubmit our clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion
of a clinical trial.

Moreover,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation
in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA, the
EMA or comparable foreign regulatory authorities. The FDA, the EMA or comparable foreign regulatory authority may conclude that a financial
relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study.
The FDA, the EMA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable
clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection,
of our marketing applications by the FDA, the EMA or comparable foreign regulatory authority, as the case may be, and may ultimately
lead to the denial of marketing approval of one or more of our product candidates.

In
addition, the FDA’s, the EMA’s and other regulatory authorities’ policies with respect to clinical trials may change
and additional government regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the EU recently
evolved. The EU Clinical Trials Regulation (CTR) which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became
applicable on January 31, 2022. While the Clinical Trials Directive required a separate clinical trial application (CTA) to be submitted
in each member state, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized
process and only requires the submission of a single application to all member states concerned. The CTR allows sponsors to make a single
submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state.
The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate
assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member
state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development
may proceed. The CTR