w🅰️fflesnsp🅰️ce

Trump has a Marty Makary problem. Bad decisions and lots of drama make the FDA commissioner a headache for the president, writes Allysia Finley on.wsj.com/3QOA0e3

$IBRX It's time to get the answers. @DrPatrick has been silent for five days. No original IBRX or ANKTIVA posts since April 27. For a CEO who normally posts multiple times a day, that is uncharacteristic. But silence cuts both directions. And the record over the last twelve months has not moved an inch. One year ago today, May 2, 2025, FDA refused to file the papillary sBLA. The stock hit $1.83 five days later. The company was hauled into class actions. Short interest sat near 40% of the float. The story was over, except it wasn't. THE BASE RATE JAMA Internal Medicine, 2021. 98 FDA Refuse to File letters studied. 72% of resubmissions were eventually approved. That number is not a promise. It is a base rate. It says the agency, given a second look at the same drug from the same company with tighter data, says yes more than two times in three. THE TWO COHORTS The pivotal trial is QUILT-3.032. Open-label, single-arm, multicenter. It enrolled two main patient groups, both with BCG-unresponsive non-muscle-invasive bladder cancer. Cohort A: patients with carcinoma in situ (CIS), the flat form. Some of these patients also had papillary tumors. This cohort produced the April 2024 approval. Cohort B: patients with papillary tumors only, no CIS, the raised form. This is what the resubmission asks FDA to add. Same drug. Same trial. Same delivery into the bladder. Same disease setting. The only difference is which form of the cancer the patient presented with. In April 2024, FDA approved ANKTIVA out of Cohort A on single-arm data. That approval anchors the US commercial business: 240M+ covered lives, permanent J-code, over a year of real-world use. International approvals and launches stack on top of it, not in place of it. The current resubmission asks FDA to extend that approval to Cohort B - on single-arm data from the same trial. That is the actual heart of the May 2, 2025 RTF: FDA approved single-arm data for one cohort and refused to file single-arm data from the other cohort of the same trial twelve months later. Same drug. Same trial. Same trial design. Different patient subgroup of the same disease. WHY NOT THE FIRST TIME? A fair question. Three answers. First: alignment. The original sBLA was filed under FDA leadership's explicit instruction, on the data the company had at the time. The reviewers refused without having articulated their own bar. The Type B end-of-phase meeting on January 20, 2026 finally surfaced FDA's specific concerns. ImmunityBio submitted additional data in February per FDA's requests and formally resubmitted in March. The agency finally defined the bar. The company met it. The 2025 application could not address questions the agency had not yet asked. Second: the original RTF was a procedural reversal, not a science failure. January 2025, an in-person meeting with CBER, CDER, and OCE leadership unanimously instructed ImmunityBio to submit on the single-arm data they had at that moment. They did. Then the review-team refused to file on grounds leadership had already cleared. A former senior FDA official, Rachel Sherman, publicly called the RTF "regulatory inaccuracies." Third: the world changed. Saudi did not exist on the original submission day. The EU Conditional Marketing Authorization did not exist. UK MHRA had not yet approved. Macau had not yet approved. NCCN had not yet listed. A full year of real-world U.S. commercial use had not yet accumulated. The 2026 resubmission is not the 2025 application with more pages stapled to the back. It is a different submission, into a different agency, in a different world. THE LEADERSHIP HAS TURNED OVER When the RTF was issued on May 2, 2025, CBER was between directors. Peter Marks had resigned in March 2025 citing "assault on scientific truth." Four days after the RTF, Marty Makary named Vinay Prasad to run CBER. Prasad's published philosophy was skeptical of single-arm accelerated approvals. Six months later, on November 12, 2025, Prasad and Makary co-authored a New England Journal of Medicine paper, "FDA's New Plausible Mechanism Pathway," that established the opposite principle: one trial plus mechanism of action can be sufficient when the biology is clear. They wrote it together. Prasad's departure was announced March 6, 2026. His last day at FDA was the end of April. Today is May 2, 2026. The CBER that decides whether to accept this filing is no longer the CBER that issued the RTF. THE NEW DATA Type B end-of-phase FDA meeting on January 20, 2026. ImmunityBio brought five years of follow-up to the table. - 96% disease-specific survival at 36 months. Median survival not yet reached. - 12-month disease-free survival: 58.2% (95% CI 46.6 - 68.2). - 12-month progression-free survival: 94.9%. - 36-month progression-free survival: 83.1%. - 12-month cystectomy-free survival: 92.2%. - 36-month cystectomy-free survival: 81.8%. FDA requested updated efficacy data after the meeting. The company submitted it. FDA acknowledged the resubmission on March 9, 2026. THE PARALLEL TRACKS All five international approvals are for the CIS form, the same form FDA approved in April 2024. They validate the drug, the mechanism, and the regulatory category. The papillary resubmission asks FDA to add the second form. Saudi SFDA approved ANKTIVA in January 2026 for both the CIS form of BCG-unresponsive bladder cancer and second-line non-small-cell lung cancer post-checkpoint. The Saudi NSCLC label cites absolute lymphocyte count as the biomarker tied to overall survival - the only regulator anywhere to write that into a drug label. Commercial launch in Saudi Arabia followed on April 21, 2026. The European Commission granted Conditional Marketing Authorization on February 16, 2026. Thirty countries. UK MHRA approved on July 7, 2025. Macau ISAF approved on March 21, 2026 - the first ANKTIVA approval in Asia. NCCN, by contrast, did move on the papillary form specifically. NCCN listed ANKTIVA + BCG for papillary disease as Category 2A on March 16, one week after FDA acknowledged the resubmission. NCCN is the guideline most U.S. insurers use for reimbursement decisions. The leading U.S. oncology expert panel endorsed the papillary indication while FDA's own filing review was still underway. RMAT designation is active throughout. And separately from this resubmission, the BCG-naive Phase 3 randomized trial - a different and much larger patient population, the upstream first-treatment market - is on track for a planned BLA submission on December 28, 2026. Its independent monitoring committee confirmed statistical power on March 27, 2026. That program is not affected by the May filing-acceptance window. It is the next thing. STAY CALM Nobody knows what FDA will decide. Nobody knows what PSS knows. The 60-day filing-acceptance window closes around May 8 to May 12, 2026, depending on the exact resubmission receipt date. But here is what is true today, on the one-year anniversary of the day the market lost the plot. The company resubmitting in March 2026 is not the company that got told no in May 2025. Twelve months of work doesn't disappear because the calendar got tense. The silence isn't the answer. Twelve months of evidence is.