Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 46

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 46
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 of the product, expected duration of treatment, seriousness of
known or potential adverse events, and whether the product is a new molecular entity. REMS can include medication guides, physician communication
plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU may include, but is not limited to, special training
or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient
registries. The FDA may require a REMS before approval or post-approval if it becomes aware of a serious risk associated with use of
the product. The requirement for a REMS can materially affect the potential market and profitability of a product.

The FDA may refer an application for a novel
drug to an advisory committee or explain why such referral was not made. Typically, an advisory committee is a panel of independent experts,
including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application
should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers
such recommendations carefully when making decisions.

Fast-Track, Breakthrough Therapy and
Priority Review Designations 

The FDA is authorized to designate certain products
for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease
or condition. These programs are referred to as fast-track designation, breakthrough therapy designation and priority review designation.

Specifically, the FDA may designate a product
for fast-track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious
or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.
For fast-track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a fast-track
product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary
evaluation of clinical data submitted by the sponsor, that a fast-track product may be effective. The sponsor must also provide, and
the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees. However,
the FDA’s time period goal for reviewing a fast-track application does not begin until the last section of the application is submitted.
In addition, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is