Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 186

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 186
---
. A Section 505(b)(2) applicant may eliminate the need
to conduct certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously approved product
is scientifically appropriate. Unlike the ANDA pathway used by developers of bioequivalent versions of innovator drugs, which does not
allow applicants to submit new clinical data other than bioavailability or bioequivalence data, the 505(b)(2) regulatory pathway does
not preclude the possibility that a follow-on applicant would need to conduct additional clinical trials or nonclinical studies; for example,
they may be seeking approval to market a previously approved drug for new indications or for a new patient population that would require
new clinical data to demonstrate safety or effectiveness. The FDA may then approve the new product for all or some of the label indications
for which the RLD has been approved, or for any new indication sought by the Section 505(b)(2) applicant, as applicable.

In addition, under the Hatch-Waxman
amendments, the FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent exclusivity for the RLD has expired.
These market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides
a period of five years of non-patent data exclusivity for a new drug containing a new chemical entity. A drug is a new chemical entity
if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible
for the action of the drug substance. In cases where such exclusivity has been granted, an ANDA or 505(b)(2) NDA may not be filed with
the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification (as described below),
in which case the applicant may submit its application four years following the original product approval.

The FDCA also provides for
a period of three years of data exclusivity for an NDA, 505(b)(2) NDA or supplement thereto if one or more new clinical investigations,
other than bioavailability or bioequivalence studies, that were conducted by or for the applicant are deemed by the FDA to be essential
to the approval of the application. This three-year exclusivity period often protects changes to a previously approved drug product, such
as a new dosage form, route of administration, combination or indication.