# We Just Asked FDA for the Meeting That Unlocks Phase 3 | Sen-Jam Pharmaceutical

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- Entity ID: wefunder:feed_item:306614
- Published at: 2026-04-23 14:10:31 UTC
- Updated at: 2026-04-30 02:17:29 UTC

## Author
Jim Iversen

## Subject
Sen-Jam Pharmaceutical

## Content
Dear Sen-Jam Investors & Community,On April 22, 2026, Sen-Jam Pharmaceutical submitted an End-of-Phase 2 meeting request to the U.S. Food and Drug Administration for SJP-001, our lead program. This is the regulatory hinge between completed early-phase work and a registrational Phase 3 program. It is, for a 505(b)(2) company our size, the single most important meeting between IND and NDA submission.We wanted you to share this with you first.What an End-of-Phase 2 meeting actually isIt is the formal sit-down with the FDA Division reviewing our IND — in our case, the Division of Nonprescription Drug Products, led by Dr. Theresa Michele. The purpose is to get the Agency on the record, in writing, about the key elements of our Phase 3 program before we begin spending Phase 3 dollars. The questions we are asking them to answer include:• Does the Agency agree with our proposed indication — prevention of symptoms associated with veisalgia?• Does the Agency agree with our proposed primary efficacy endpoint?• Does the Agency agree with the design of our Phase 2b/3 trials?• Does the Agency agree that the Combination Rule has been met?• Does the Agency agree with our clinical pharmacology package, our proposed nonclinical toxicology plan, and a full pediatric development waiver?What we are walking in withA completed Phase 2A trial conducted at Cliantha Research in Toronto — 55 subjects enrolled, 46 completed, a four-period factorial crossover design. The study demonstrated improved efficacy over placebo with faster symptom resolution, and our multi-symptom analysis showed that the combination addresses both of the symptom domains covered by the component drugs — the prostaglandin domain (naproxen) and the histamine domain (fexofenadine). That is the evidence base for our position that FDA’s Combination Rule has been met.Because both naproxen and fexofenadine are long-marketed, well-characterized OTC products, SJP-001 is proceeding under the 505(b)(2) regulatory pathway. That means we can leverage decades of existing safety data from the literature and from the approved product labels, rather than re-run studies the Agency has already reviewed. It is the efficient path to market for a combination of two known entities — and it is exactly the path this program was designed around from day one.What happens next• May 22, 2026 — Briefing package submitted to FDA• Late June 2026 — Virtual face-to-face meeting with the Division• ~30 days after the meeting — Finalized written meeting minutesThose minutes are the document that turns our Phase 3 plan into the Phase 3 plan FDA has reviewed. They are the reference point for everything that follows — Phase 3 execution through our TASK Clinical agreement, the out-licensing conversations we continue to advance with global pharma, and the next chapter of the Sen-Jam platform.A note to the 1,455 of you who got us hereNone of this happens without this community. Over 1,455 of you backed this work through our Wefunder campaigns — more than $6.3 million deployed to get us to where we are today. You funded the Phase 2A trial at Cliantha. You funded the regulatory work that wrote the letter that went to Dr. Michele’s desk yesterday. You funded Atlas — the Innate Inflammation Engine we have been building behind the lead asset — and you have provided financial support across our entire platform SJP-002, SJP-002C, SJP-003, SJP-004, and SJP-005, SJP-006, SJP-007, & SJP-100.This was always a platform play. Prove the thesis with SJP-001, then run it across a pipeline of mast cell stabilizer + NSAID combinations that address inflammatory conditions where the standard of care has not meaningfully improved in decades. Today we are one step closer to that thesis being validated by the agency whose validation matters most.Thank you for being with us.Jim