Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 221

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 221
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 the FDA before a drug may be marketed in the United States generally involves the following:

| ● | completion of non-clinical laboratory tests, preclinical studies            
 according to cGLP and manufacturing of clinical supplies according to cGMP; |

| ● | submission to the FDA of an IND, which must become effective 
 before human clinical trials may begin;                      |

| ● | approval by an independent IRB, at each clinical site before 
 each trial may be initiated;                                 |

| ● | performance of adequate and well-controlled human clinical                                                   
 trials according to cGCP, to establish the safety and efficacy of the proposed product for its intended use; |

| ● | preparation and submission to the FDA of an NDA, for a drug; |

| ● | satisfactory completion of an FDA advisory committee review, 
 if applicable;                                               |

| ● | satisfactory completion of an FDA inspection of the manufacturing                                                    
 facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP; and |

| ● | payment of user fees and the FDA review and approval of the 
 NDA.                                                        |

The testing and approval process requires substantial time, effort and financial resources and we cannot be certain that any approvals for our drug candidates, or any future drug candidates we may develop, will be granted on a timely basis, if at all. Once a drug candidate is identified for development, it enters the non-clinical testing stage. Non-clinical tests include laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as preclinical studies. An IND sponsor must submit the results of the non-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND prior to commencing any testing in humans. An IND sponsor must also include a protocol detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some non-clinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions related to a proposed clinical trial and places the trial on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also