# SJP-001 FDA End-of-Phase 2 Meeting — Outcome, Path Forward & Investor Webinar | Sen-Jam Pharmaceutical

- Canonical URL: https://wefunder.com/feed/347896
- Entity ID: wefunder:feed_item:347896
- Published at: 2026-07-05 16:54:24 UTC
- Updated at: 2026-07-06 14:30:09 UTC

## Author
Jim Iversen

## Subject
Sen-Jam Pharmaceutical

## Content
Dear Sen-Jam Investors & WeFunder Community,I want to share the outcome of our July 1 End-of-Phase 2 meeting with the FDA on SJP-001, and what we believe it means for the road ahead.We entered the meeting seeking alignment on a combined Phase 2b/3 program focused on prevention. The Agency was constructive, cooperative, and supportive throughout the discussion, but raised consumer-protection considerations specific to a prevention indication in this category.The FDA strongly recommended that we consider advancing SJP-001 first for treatment of hangover and alcohol-related recovery symptoms, where those consumer-protection considerations may be less complex, and pursue prevention on a subsequent track. They were also careful to note that they are not providing business advice, and we have not yet made a final strategic decision on sequencing.We view this as a constructive and important outcome. The FDA did not stop the program; they allowed us to proceed, endorsed our combination methodology, and offered direct engagement on the design and endpoints of the next trial. The Agency also engaged deeply with our science and recognized the scientific rigor of our clinical program under Jackie’s leadership.We also met with KVK Tech last week, and they were encouraged by the meeting outcome. Their view is that a treatment-first strategy could create the opportunity to get a product to market faster, with prevention potentially following as a line extension. That perspective is encouraging as we evaluate the best path forward, because it supports both regulatory clarity and commercial practicality.While the FDA’s recommendation may change the sequence we originally envisioned, it gives us a clearer opportunity to advance SJP-001 with the Agency’s active input. We will make our final sequencing decision after receiving and reviewing the official meeting minutes. Either way, we are still advancing the first FDA approved product for the prevention or treatment of alcohol hangoverOur broader thesis remains intact: resolving innate inflammation upstream can help people live longer, healthier lives. SJP-001 is one of fourteen assets built from this same biology, and our conviction in the platform remains unchanged.Official FDA meeting minutes are expected within 30 days. Once we receive and review those minutes, we plan to host an investor webinar to walk through the outcome, the next study design, the expected timeline, and how this path fits into Sen-Jam’s broader value creation strategy. Details will follow once the minutes are in hand.Thank you for your continued partnership, belief, and support as we move forward with a clearer understanding of the regulatory path ahead.With gratitude,Jim