Company: TELO
Filing Date: 2025-11-28
Form Type: PRER14A
Source: 0001493152-25-025406
Chunk: 81

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-11-28
Form: PRER14A
Chunk 81
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 data, partnerships with local ophthalmology networks) will be essential. Also, given the forecasted growth rates outside the U.S., companies may increasingly tilt allocation of resources (R&D, commercialization) toward global markets rather than just U.S. alone.

Overall, while the U.S remains a large and influential market, treatment of AMD outside the U.S. is increasingly important: it is growing steadily, has region-specific dynamics, and is becoming more heterogeneous in terms of both challenge and opportunity.

Regulation

Regulation and Procedures Governing Approval of Medicinal Products in the European Union and the UK

The EU, and the UK comprehensively regulate, among other things, the development, manufacturing, placing on the market, advertising, distribution, import and export of medicinal products. Particularly, the placing on the market of a medicinal product for human use in the EU requires a marketing authorization (MA). Main Provisions governing medicinal products in the EU are Directive 2001/83/EC and Regulation (EC) No 726/2004 (each as amended). Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000 (each as amended) are also of particular relevance for orphan medicinal products. While directives need to be transposed into national law by member states of the EU (EU Member States) before they are applicable, regulations directly apply in the EU Member States once these have been enacted. The process governing approval of MA applications (MAA) for the placing on the market of medicinal products in the EU and the UK generally follows the same lines as in the U.S. It entails satisfactory completion of pharmaceutical development, pre-clinical trials and adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal product for each proposed indication. The EU also requires the submission to relevant competent authorities for clinical trials authorization and to the European Medicines Agency (EMA) or to competent authorities in EU member states and granting of such MA by the EU Commission or relevant national authorities before the medicinal product can be marketed and sold in the EU or the relevant EU Member States. The below mentioned principles and rules generally apply within the EEA, i.e., the EU including Iceland, Liechtenstein and Norway.

Following the UK’s departure from the EU, a separate MA is required from the Medicines and Healthcare Products Regulatory Agency (the MHRA), the UK medicines regulator, in order to place medicinal products on the market in the Great Britain (England, Wales and Scotland), which has been extended