Company: INDP
Filing Date: 2025-02-12
Form Type: S-1
Source: 0001493152-25-006068
Chunk: 92

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-02-12
Form: S-1
Chunk 92
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 67 |

The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted sequentially, they may overlap or be combined.

| ● | Phase                                                                                                                                       
 1. The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition. These        
 studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product           
 in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.                    |
| ● | Phase                                                                                                                                       
 2. The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary  
 efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical     
 trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.                         |
| ● | Phase                                                                                                                                       
 3. The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically significant 
 evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.          
 These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate    
 basis for product approval.                                                                                                                 |

Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA.

During the development of a product candidate, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at the end of Phase 2, and before an NDA or BLA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development. Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMPs. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods