Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 42

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 42
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 sponsor and the
FDA must resolve any outstanding concerns before clinical trials can begin.

Following commencement of a clinical trial under
an IND, the FDA may also place a clinical hold or partial clinical hold on that trial. A clinical hold is an order issued by the FDA
to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is a delay
or suspension of only part of the clinical work requested under the IND. For example, a specific protocol or part of a protocol is not
allowed to proceed, while other protocols may do so. No more than 30 days after imposition of a clinical hold or partial clinical hold,
the FDA will provide the sponsor a written explanation of the basis for the hold.

Following issuance of a clinical hold or partial
clinical hold, an investigation may only resume after the FDA has notified the sponsor that the investigation may proceed. The FDA will
base that determination on information provided by the sponsor correcting the deficiencies previously cited or otherwise satisfying the
FDA that the investigation can proceed.

20

A sponsor may choose, but is not required, to
conduct a foreign clinical study under an IND. When a foreign clinical study is conducted under an IND, all FDA IND requirements must
be met unless waived. When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies
with certain FDA requirements in order to use the study as support for an IND or application for marketing approval.

In addition to the IND requirements, an IRB representing
each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that
institution, and the IRB must conduct continuing review and reapprove the study at least annually. The IRB must review and approve, among
other things, the study protocol and informed consent information to be provided to study subjects. An IRB must operate in compliance
with FDA regulations. An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents,
if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated
with unexpected serious harm to patients.

Additionally, some trials are overseen by an
independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee. This group
provides authorization for whether or not a trial may move forward at designated check points based on access that only the group maintains
to available data from the study