Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 75

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 75
---
 conditions for which where is an unmet medical need (there is no satisfactory method
of diagnosis, prevention or treatment in the European Union or, if there is, the new medicine will bring a major therapeutic advantage)
and they must demonstrate the potential to address the unmet medical need by introducing new methods or therapy or improving existing
ones. Applicants will typically be at the exploratory clinical trial phase of development and will have preliminary clinical evidence
in patients to demonstrate the promising activity of the medicine and its potential to address to a significant extent an unmet medical
need. In exceptional cases, applicants from the academic sector or SMEs (small and medium sized enterprises) may submit an eligibility
request at an earlier stage of development if compelling non-clinical data in a relevant model provide early evidence of promising activity,
and first in man studies indicate adequate exposure for the desired pharmacotherapeutic effects and tolerability.

If a medicine is selected for the PRIME scheme,
EMA:

  appoints a rapporteur from the CHMP or from the Committee for Advanced Therapies (CAT) to provide continuous support and to build up knowledge of the medicine in advance of the filing of a mark...  

  issues guidance on the applicant’s overall development plan and regulatory strategy;  

  organizes a kick-off meeting with the rapporteur and experts from relevant EMA committees and working groups;  

  provides a dedicated EMA contact person; and  

  provides scientific advice at key development milestones, involving additional stakeholders, such as health technology assessment bodies and patients, as needed.  

Medicines that are selected
for the PRIME scheme are also expected to benefit from EMA’s accelerated assessment procedure at the time of application for marketing
authorization. Where, during the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme
may be withdrawn.

Pediatric Development

In the EEA, companies developing
a new medicinal product must agree upon a Pediatric Investigation Plan, or PIP, with the EMA’s Pediatric Committee, or PDCO, and
must conduct pediatric clinical trials in accordance with that PIP, unless a waiver applies, (e. g., because the relevant disease or condition
occurs only in adults). The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the drug
for which marketing authorization is being sought. The marketing authorization application for the product must include the results of
pediatric clinical trials conducted in accordance with the PIP, unless a waiver