Ethan

A rare video (I am desperate) but I really need you all to hear me. I want you all to know it brings me zero pleasure to have to keep repeating myself but I do it for the ignorant people who don't understand why this is happening. Please get your sh*t together in #LongCovid research. If I am dealing with these vascular emergencies so are the kids. They deserve prevention tests and treatments NOW!

$IBRX 24 hours ago, a 688-patient Phase 3 trial appeared on ClinicalTrials.gov. NCT07551544. Estimated start May 15, 2026. Primary completion May 2032. Some peole have read this as a worry signal - the reasoning being that the FDA must be asking for more details on the sBLA. That reading runs in the wrong direction. Companies do not register and fund six-year confirmatory Phase 3 trials for drugs they expect to be denied. They register them as the structural prerequisite for accelerated approval - the post-marketing study the FDA requires when it greenlights a drug fast. The new trial is not pressure on a weak sBLA. It is the scaffolding for an approval the company is positioning to receive. To see why, three regulatory tracks need to be separated. THE FOUR PIECES There are not three regulatory tracks. There are four. [1] The current approval - BLA 761336. April 22, 2024. ANKTIVA + BCG for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Single-arm data from QUILT-3.032 Cohort A. Roughly 8,000 addressable patients per year in the US. Q1 2026 revenue: $44.2 million, up 168% year over year. Live, selling, growing. [2] The sBLA in the FDA's pre-filing window. ANKTIVA + BCG for BCG-unresponsive papillary-only disease - patients who present with papillary tumors but no concurrent CIS. Same QUILT-3.032 trial, different cohort (Cohort B, 80 patients). Originally filed March 2025, received a Refuse to File letter on May 2, 2025. The agency wanted more. ImmunityBio submitted additional data through January and February 2026. The FDA invited resubmission. The company resubmitted on March 9, 2026. As of late April 2026 - roughly 50 days post-resubmission - no formal FDA filing decision has been publicly disclosed. The application sits in the agency's pre-filing decision window. That decision is itself a near-term observable signal. NCCN Guidelines version 1.2026 (March 16, 2026) added ANKTIVA as Category 2A for this exact indication - external scientific validation independent of the FDA decision. A German real-world evidence study (d-uo registry, presented at EAU26 in London) showed a hazard ratio of 0.4 for duration of response - independent third-party data confirming the effect. [3] The December 28, 2026 sBLA. Different population. Different trial. Different data quality. This filing is for BCG-NAÏVE bladder cancer - the much earlier line, before patients have failed BCG. Roughly 30,000 to 40,000 US patients per year. About four times the addressable market of the current approved indication. The supporting trial is QUILT-2.005. It started in 2014 as a 9-patient Phase 1b. Six of the nine entered long-term follow-up, and at last report all six (100%) remained in complete remission with a median survival of 8.8 years and intact bladders. The Phase 1b grew into a 366-patient randomized Phase 2b. ANKTIVA + BCG vs BCG alone. Primary endpoint: complete response rate. Enrollment closed February 26, 2026. [4] NCT07551544 - posted to ClinicalTrials.gov on April 27, 2026. This is the new trial that surfaced 24 hours ago. Phase 3, ResQ1320-NMIBC. ANKTIVA + BCG vs BCG monotherapy in BCG-naïve OR BCG-exposed papillary-only Ta/T1 disease, no CIS. 688 patients. Estimated start May 15, 2026. Primary completion May 2032. This is NOT what supports the December 2026 filing. Its readout is six years away. It is most likely the post-marketing confirmatory study the FDA will require as a condition of granting accelerated approval based on QUILT-2.005, plus a label-expansion play to widen the BCG-naïve indication into BCG-exposed. THE SIGNAL The part that almost no one is talking about: On March 27, 2026, ImmunityBio announced that the Independent Data Monitoring Committee for QUILT-2.005 reviewed interim data and concluded N=366 is statistically powered. No additional enrollment required. The sBLA submission is on track for Q4 2026 - specifically December 28, 2026. The FDA's specific objections to the May 2025 RTF were never publicly disclosed. But the agency's own subsequent letters are on the public record. In a September 9, 2025 Untitled Letter signed by CDER Director George Tidmarsh, the FDA stated that QUILT-3.032's "reported cystectomy avoidance and DSS results are uninterpretable; absent an appropriate comparator." A follow-up Untitled Letter on January 7, 2026 noted the September letter had not been adequately addressed. Former FDA official Rachel Sherman called the original RTF contents "regulatory inaccuracies." QUILT-2.005 has the comparator. 366 patients randomized between BCG alone and ANKTIVA + BCG. The exact study design the FDA called missing. On March 27, the IDMC said the randomized comparator-controlled study is statistically sufficient. No more enrollment needed. Filing on track. The "uninterpretable without comparator" critique has been on the public record since September 2025. On March 27, 2026, ImmunityBio answered it. THE STRUCTURE Three sBLA tracks, each pulling in a population the prior track did not: - Approved (April 2024): BCG-unresponsive CIS. ~8K patients. - Under review (March 2026): BCG-unresponsive papillary-only. Incremental. - Filing December 28, 2026: BCG-naïve. ~30,000-40,000 patients. With the randomized comparator. - The fourth piece - NCT07551544 - is the post-marketing confirmatory Phase 3. Forward-looking, not a sign of fresh FDA pressure. WHAT TO WATCH If a fresh FDA ask had materialized on the BCG-naïve filing, it would surface as an 8-K or a press release. Through April 27, 2026, neither has appeared. Two near-term observable signals are open: First, the FDA's filing decision on the March 9 papillary resubmission. The agency has been silent for 50+ days. A filing acceptance, a refuse-to-file, or a request for additional information would each move the stock and reset the regulatory narrative. Second, the December 28, 2026 BCG-naïve sBLA filing. With QUILT-2.005 enrollment closed, IDMC powered, and the 8.8-year Phase 1b durability data already in the dataset, there is no public reason to believe the company will miss the date. That filing addresses a market four times larger than the one that produced $44 million in a single quarter. The Phase 3 that surfaced 24 hours ago doesn't read out until 2032. The filing it makes possible goes in December 28, 2026.

Thrilled to report that my injured patient in Japan is responding well to treatment. DFPP - double filtration plasmapheresis - and IV stem cell growth factors are not available in the US, but we are hoping to start a trial soon. Thank you @KevinMcCairnPhD @CharlesRixey and team!

@awgaffney Underlying cause of unexplained symptoms captured as "EDS/MCAS/POTS/chronic lyme": Developmental trauma, excessive stress, overstimulation. Based on my experience.