Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 165

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 165
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 the company sponsoring an application. 102 A drug may first come to the attention of the TGA when an application for marketing is received or when an Australian clinical trial is being planned. For clinical trials, the sponsoring company may submit preliminary data for evaluation to the TGA or notify the TGA that the trial has been approved by an institutional Ethics Committee. The drug evaluation process for new chemical entities is as follows: Application

| ● | Check to see data complies with Australian guidelines. |

| ● | Invoice sponsor for 75% of evaluation fee. |

Evaluation

| ● | Evaluate pharmaceutical 
 and chemical data.      |

| ● | Evaluate animal pharmacology 
 and toxicology data.         |

| ● | Evaluate clinical data. |

| ● | Evaluation Unit reviews                                                                                     
 reports (coordinates external evaluations if used), prepares a summary and makes an initial recommendation. |

| ● | Pre ADEC consultation with 
 sponsor.                   |

| ● | Prepare approved product                               
 information and consider consumer product information. |

| ● | Submit final package of                                            
 summaries and recommendations to the ADEC (six meetings per year). |

Approval

| ● | ADEC review and advice 
 to the TGA.            |

| ● | Final decision by the TGA. |

| ● | Finalize conditions of 
 registration.          |

| ● | Advice to sponsor, invoice   
 final 25% of evaluation fee. |

| ● | For new chemical entity,                                     
 advise drug information centers, forensic laboratories, etc. |

Registration

| ● | Sponsor applies to register                                  
 the product on the Australian Register of Therapeutic Goods. |

| ● | Supply is permitted once            
 the applicable number is allocated. |

The drug’s chemistry, toxicology and clinical use are evaluated using data submitted by the sponsoring company. Most of the evaluations are done within the TGA, but external evaluations can be used. When all the data have been evaluated, the application is considered by the Australian Drug Evaluation Committee (“ADEC”). This committee is a group of doctors appointed by the Minister to advise on the suitability of drugs for marketing in Australia. The TGA takes into consideration the advice received from the ADEC when making a final recommendation. 103 The evaluation process relates to pre-marketing activity, but the TGA is also responsible for drugs after they are marketed. Other activities under the control of the TGA include:

| ● | maintenance of the Australian Register of Therapeutic 
 Goods for the registration and listing of products;   |

| ● | control of drug