Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 21

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 21
---
 NDA or BLA is submitted, the application
may be eligible for priority review. A fast track product candidate may also be eligible for rolling review, where the FDA may consider
for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule
for the submission of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule
is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

18

A
product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy
designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical
evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial
improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early
in clinical development. The designation includes all of the fast track program features, as well as more intensive FDA interaction and
guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate,
including involvement of senior managers.

Any
marketing application for a drug or biologic submitted to the FDA for approval, including a product candidate with a fast track designation
and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval
process, such as priority review. A product candidate is eligible for priority review if it has the potential to provide a significant
improvement in the treatment, diagnosis or prevention of a serious disease or condition. For new-molecular-entity NDAs and original BLAs,
priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day
filing date (as compared to ten months under standard review).

Additionally,
depending on the design of the applicable clinical trials, product candidates studied for their safety and effectiveness in treating
serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product candidate has
an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured
earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality
or other clinical