Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 191

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 191
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 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 exclusivity or listed patents. This six-month exclusivity may
be granted if an NDA sponsor submits pediatric data that fairly respond to a Written Request from the FDA for such data. The data do not
need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond
to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted
by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product
are extended by six months, including orphan drug exclusivity. This is not a patent term extension, but it effectively extends the regulatory
period during which the FDA cannot approve another application. The FDA’s issuance of a Written Request does not require the sponsor
to undertake the described studies.

Orphan Drug Designation and Exclusivity

Under the Orphan