Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 69

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 69
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, which may involve conducting additional preclinical studies and clinical trials.

Expedited Review and Approval

The FDA has various programs,
including fast track designation, priority review, accelerated approval, and breakthrough therapy designation, which are intended to expedite
or simplify the process for reviewing drugs and/or provide for approval on the basis of surrogate endpoints. Even if a drug qualifies
for one or more of these programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the
time period for FDA review or approval will not be shortened. In particular, if accelerated approval is granted for any particular drug
candidate, the FDA can subsequently revoke the marketing authorization for such product if post-market clinical trial results are unsuccessful.
Generally, drugs that may be eligible for these programs are those for serious or life-threatening diseases or conditions, those with
the potential to address unmet medical needs, and those that offer meaningful benefits over existing treatments.

Other U. S. Regulatory Requirements

After approval, products are
subject to extensive continuing regulation by the FDA, which include company obligations to manufacture products in accordance with GMP,
maintain and provide to the FDA updated safety and efficacy information, report adverse experiences with the product, keep certain records
and submit periodic reports, obtain FDA approval of certain manufacturing or labelling changes and comply with FDA promotion and advertising
requirements and restrictions. Failure to meet these obligations can result in various adverse consequences, both voluntary and FDA-imposed,
including product recalls, withdrawal of approval, restrictions on marketing, and the imposition of civil fines and criminal penalties
against the BLA holder - all of which may become public. In addition, later discovery of previously unknown safety or efficacy issues
may result in restrictions on the product, manufacturer or application holder.

We, and any
manufacturers of our drug candidates, are required to comply with applicable FDA manufacturing requirements contained in the
FDA’s GMP regulations. GMP regulations require, among other things, quality control and quality assurance as well as the
corresponding maintenance of records and documentation. The manufacturing facilities for our drug candidates must meet GMP
requirements. We, and any third-party manufacturers, are also subject to periodic inspections of facilities by the FDA and other
authorities, including procedures and operations used in the testing and manufacture of our drug candidates to assess our compliance
with applicable regulations.

With respect to post-market
product advertising and promotion, the FDA imposes a number of complex regulations on entities that advertise and promote pharmaceuticals,
which include, among others