Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 67

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 67
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 the objectives of the study, the parameters to be used in monitoring safety and the effectiveness
criteria to be evaluated. Each protocol must be provided to the FDA as part of a separate submission to the IND. Further, an Institutional
Review Board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the study protocol and informed
consent information for study subjects for any clinical trial before it commences at that center, and the IRB must monitor the study until
it is completed. There are also requirements governing reporting of ongoing clinical trials and clinical trial results to public registries.
Study subjects must sign an informed consent form before participating in a clinical trial.

Progress reports detailing
the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and
the investigators for serious and unexpected adverse reactions in case of an open IND. For purposes of an NDA or BLA submission and approval,
human clinical trials are typically conducted in the following sequential phases, which may overlap:

  Phase I: Trials are initially conducted in a limited population of healthy human subjects or patients to test the drug candidate for safety and dose tolerance (in oncology Phase I trials are of...  

  Phase II: The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing sche...  
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  Phase III: The investigational product is administered to an expanded patient population in adequate and well-controlled studies to further evaluate dosage, to provide statistically significant...  
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  Phase IV: In some cases, the FDA may condition approval of an NDA or BLA on the sponsor’s agreement to conduct additional clinical trials to further assess the drug candidate’s safety, purity a...  
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Concurrent with clinical studies,
sponsors usually complete additional animal studies and must also develop additional information about the product and finalize a process
for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable
of consistently producing quality batches of the drug candidate and