Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 15

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 15
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 performed in accordance with the Good Laboratory Practices
    (GLP) regulations and other applicable regulations;

    ●
    submission to the FDA an
    IND, which must become effective before human clinical studies may begin and must be updated annually;

    ●
    approval by an independent
    institutional review board (IRB) or ethics committee representing each clinical site before each clinical study may be initiated;

    ●
    performance of adequate
    and well-controlled human clinical studies in accordance with Good Clinical Practice (GCP), requirements to establish the safety
    and efficacy, or with respect to biologics, the safety, purity and potency of the product candidate for each proposed indication;

    ●
    preparation of and submission
    to the FDA of a new drug application (NDA) or biologics license application, (BLA), after completion of all pivotal clinical studies;

    ●
    a determination by the
    FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

    ●
    potential review of the
    product application by an FDA advisory committee, where appropriate and if applicable;

15

    ●
    satisfactory completion
    of an FDA pre-approval inspection of the manufacturing facilities where the proposed product drug is produced to assess compliance
    with cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality
    and purity, and of potential inspection of selected clinical investigation sites to assess compliance with GCPs; and

    ●
    FDA review and approval
    of an NDA or BLA prior to any commercial marketing or sale of the drug in the United States.

Once
a product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations
of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical
tests, together with manufacturing information and analytical data, to the FDA as part of an IND. An IND is a request for authorization
from the FDA to administer an investigational drug product to humans. An IND will also include a protocol detailing, among other things,
the objectives of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated,
if the trial includes an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically
becomes effective 30 days after receipt