Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 232

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 232
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 of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide
that the time period for FDA review or approval will not be shortened.

Accelerated Approval Pathway

Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions and
that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval. Such products may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an
effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on an intermediate clinical endpoint that can be measured earlier than irreversible morbidity or mortality, or IMM, that is reasonably likely to predict an
effect on IMM or other clinical benefits, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA will generally require the sponsor of a
drug receiving accelerated approval to perform adequate and well-controlled confirmatory clinical studies to verify and describe the drug’s clinical benefit, and may require that such confirmatory trials be underway prior to granting
accelerated approval. Sponsors are also required to send updates to the FDA every 6 months on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly.

NDA sponsors must conduct such post-approval confirmatory studies in a diligent manner, and as a result a product candidate approved on this basis is subject
to rigorous post-marketing compliance requirements.

Products receiving accelerated approval may be subject to expedited withdrawal
procedures if the sponsor fails to conduct the required confirmatory studies in a timely manner or if such studies fail to verify the predicted clinical benefit. In addition, all promotional materials for product candidates being considered and
approved under the accelerated approval pathway are subject to prior review by the FDA, which could adversely impact the timing of the commercial launch of the product. Drugs granted accelerated approval must meet the same statutory standards for
safety and effectiveness as those granted traditional approval.

Post-Approval Requirements

Following approval of a new drug, the manufacturer and the approved product are subject to pervasive and continuing regulation by the FDA,
including, among other things, requirements relating to monitoring and record-keeping, reporting of adverse experiences with the product, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After
approval, most changes to the approved product, such as adding new indications, certain manufacturing changes and additional labeling claims, are subject to further