Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 189

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 189
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 the FDASIA in 2012, PREA
was made permanent and sponsors are required submit pediatric study plans to FDA prior to the assessment data. In particular, a sponsor
that is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage
form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase
2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/III study. The
initial PSP must contain an outline of the proposed pediatric study or studies the applicant plans to conduct, including study objectives
and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information and
any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies
along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to
an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical
studies, early phase clinical trials and/or other clinical development programs.

The FDA may, on its own initiative
or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for
use in adults, or full or partial waivers from the pediatric data requirements. The law now requires the FDA to send a PREA Non-Compliance
letter to sponsors who have failed to submit their pediatric assessments required under PREA, have failed to seek or obtain a deferral
or deferral extension or have failed to request approval for a required pediatric formulation. It further requires the FDA to publicly
post the PREA Non-Compliance letter and sponsor’s response. Unless otherwise required by regulation, the pediatric data requirements
do not apply to products with orphan designation, although FDA has taken steps to limit what it considers abuse of this statutory exemption
in PREA by announcing that it does not intend to grant any additional orphan drug designations for rare pediatric subpopulations of what
is otherwise a common disease.

In addition, pediatric exclusivity
is another type of non-patent marketing exclusivity in the United States that, if granted, provides for the attachment of an additional
six months of marketing protection to the term of any existing regulatory exclus