Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 66

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 66
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 filing and, even if filed,
that any approval will be granted on a timely basis, if at all.

The manufacturing and quality,
as well as preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot
guarantee approval of our drug candidates will be granted on a timely basis, if at all. Notably, the FDA may reach different conclusions
than we have after analyzing the same data, or there may difference of opinion amongst members of FDA’s review team.

The FDA may inspect and
audit domestic and foreign development facilities, planned production facilities, clinical trial sites and laboratory facilities.
There is a pre-approval inspection after submission to market a new product, routine inspection of a regulated facility and a
“for-cause” inspection to investigate a specific problem that has come to FDA’s attention. After the product is
approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval
described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic
unannounced inspections of production and quality control facilities by FDA’s field investigators and analysts.

Preclinical tests include
laboratory evaluation of toxicity in animals and in vitro (laboratory tests). The results of preclinical tests, together with manufacturing
information and analytical data, are submitted as part of an IND application to the FDA. The IND application is based on the results of
initial testing done on animals for pharmacology and toxicity, which is used to develop a plan for testing the drug on humans. Only after
preclinical testing, FDA determines whether the drug should be tested in people.

Further, an independent institutional
review board, or IRB, covering each medical center proposing to conduct clinical trials must review and approve the plan for any clinical
trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a
clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable
health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations, which include requirements that
all research subjects provide informed consent and that all clinical studies be conducted under the supervision of one or more qualified
investigators.

Clinical trials (under an
IND) involve administration of the investigational drug to human subjects under the supervision of qualified investigators. Clinical trials
are conducted under protocols detailing