Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 68

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 68
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, among other things, the manufacturer must develop and validate methods
for testing the identity, strength, quality and purity of the final product. Moreover, appropriate packaging must be tested and stability
studies must be conducted to assure product integrity and demonstrate that the drug candidate does not undergo unacceptable deterioration
over its shelf life.

The results of product development,
preclinical studies and clinical trials, along with the aforementioned manufacturing information, are submitted to the FDA as part of
a BLA/NDA. Under the Prescription Drug User Fee Act, or PDUFA, the FDA agrees to specific goals for NDA/BLA review time. The testing and
approval process requires substantial time, effort and financial resources. The FDA will review the BLA/NDA and may deem it to be inadequate
to support approval, and we cannot be sure that any approval will be granted on a timely basis, if at all. The FDA may also refer the
application to the appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to
whether the application should be approved. The FDA is not bound by the recommendations of the advisory committee, but it typically follows
such recommendations.

The FDA may deny approval
of a BLA/NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or additional pivotal
Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the NDA/BLA does not satisfy the criteria
for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor does. Once
issued, product approval may be withdrawn by the FDA if ongoing regulatory requirements are not met or if safety problems occur after
the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs
to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing
of a product based on the results of these post-marketing programs which may include pediatric assessment, and potentially studies required
for an application for a new indication, new dosage form, a new dosing regimen, a new route of administration or a new active ingredient.
Products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there
are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, approval of a
new or supplemental BLA may be required