Dave Bennett

$IBRX Warning Letter. 21% stock drop. $2 billion wiped out. Five class action lawsuits. That was the headline. Today, ImmunityBio filed its formal response to the FDA. Inside it: a single footnote that cites the government's own words against itself. And a revelation that one of the two things the FDA warned them about was never even shown to the public. THE PHANTOM AD The FDA's Warning Letter cited two pieces of content: a TV advertisement and a podcast titled "Is the FDA BLOCKING Life Saving Cancer Treatments?" In its response, ImmunityBio informed the FDA that the television advertisement was never aired. Never broadcast. Never disseminated to the public. The ad the FDA warned them about does not exist in the wild. The FDA issued a formal Warning Letter - the kind that crashes stock prices and triggers class action lawsuits - partly about content that never reached a single patient. The podcast was real. ImmunityBio removed it from its corporate website and requested removal from third-party platforms. Corrective action taken. No argument. But the TV ad? A phantom. THE RESPONSE ImmunityBio's response is textbook compliance. No fighting. No defiance. No tweets from @DrPatrick . The spokesperson is Richard Adcock, President and CEO - not the founder. The corrective actions: - Comprehensive review of all promotional materials - Mandatory executive training on FDA promotional regulations - Expanded Promotional Review Committee protocols - Engagement of external regulatory counsel to audit future communications Adcock's statement: "ImmunityBio takes promotional compliance with the utmost seriousness. We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies." That is a company doing everything the FDA asked. Removing content. Training executives. Hiring outside auditors. Separating the vision from the label. THE FOOTNOTE Then comes the section titled "Clarifying the Context of Scientific Innovation." ImmunityBio explains that Dr. Soon-Shiong's statements on the podcast were "aspirational and forward-looking opinions regarding his vision for the company's drug development pipeline and the underlying science." And then a single bullet point that changes everything: "The characterization of the IL-15 molecule, the foundation of ANKTIVA, as a highly promising agent was based on an independent assessment by the National Cancer Institute (NCI) during its Immunotherapy Agent Workshop dated July 12, 2007." Read that again. The FDA warned ImmunityBio for calling IL-15 the most promising molecule in cancer immunotherapy. ImmunityBio's response: a fellow agency within the same federal government - the National Cancer Institute - said it first. Nineteen years ago. In a formal workshop attended by scientific leaders from the NCI, NIH, FDA, AACR, and ASH. Where 124 agents were nominated, 30 were presented, and 20 were ranked. IL-15 was ranked #1. The molecule ranked #2 on that same list became Keytruda - the top-selling drug in the world at $25 billion in annual revenue. The government is warning a company for repeating what the government itself concluded in 2007. That is the footnote. And the footnote is the entire story. MEANWHILE, IN JEDDAH On the same day this response was filed, a Saudi molecular biochemistry consultant posted from Jeddah: "Dr. Patrick Soon-Shiong points to two potential paths for patients: Either waiting on long lists in the United States until the treatment is approved, Or heading to Saudi Arabia to start treatment directly. The technology is currently available at King Faisal Specialist Hospital." That is not an IBRX investor. That is a Saudi medical professional telling American cancer patients to fly to Riyadh. Because while the FDA spends its time policing a podcast about whether IL-15 is promising, the Saudi FDA approved ANKTIVA for both bladder cancer and lung cancer. King Faisal Specialist Hospital - the institution where PSS signed an MOU during the Trump-MBS summit in May 2025 - has the technology available. The FDA has the resources to issue Warning Letters about television advertisements that were never aired. The FDA does not have the resources to approve ANKTIVA for lung cancer - the indication where Saudi Arabia already approved it, where a Saudi doctor is now publicly telling American patients to fly east for treatment developed in Los Angeles. THE LAWSUITS Within days of the stock dropping 21%, the ambulance chasers arrived. Hagens Berman. Pomerantz. Kirby McInerney. Kahn Swick & Foti. At least five law firms filed securities class action lawsuits. The headlines: "$2 Billion Market Capitalization Wiped Out." "Securities Fraud." "Misleading Cancer Treatment Claims." The class period: January 19, 2026 (when the podcast aired) through March 24, 2026 (when the stock dropped). Lead plaintiff deadline: May 26, 2026. If you own shares, you got the emails. You saw the press releases. They were designed to make you panic. That is how predatory class action firms work - they file the moment any biotech drops 20% on regulatory news, attach the scariest headlines they can find, and hope enough shareholders sell in fear to create a settlement opportunity. Now look at what today's response actually does to those lawsuits: 1. The TV ad was never aired. A core pillar of the FDA complaint - and by extension the lawsuits - is about content that never reached the public. Hard to claim investors were "misled" by something nobody saw. 2. The NCI footnote. PSS's characterization of IL-15 as the most promising molecule wasn't his opinion - it was the National Cancer Institute's own published assessment from July 12, 2007. That is a factual basis, not puffery. The lawsuits allege PSS made "unsupported claims." The NCI's own workshop is the support. 3. ImmunityBio explicitly invoked safe harbor language - PSS's statements were "aspirational and forward-looking opinions." Securities fraud claims against forward-looking statements face a high dismissal bar. 4. Comprehensive corrective action was taken immediately - removing the podcast, training executives, hiring external counsel. That eliminates the "they knew and refused to act" element that class actions need. These lawsuits are standard predatory filings. They are filed against virtually every biotech that experiences a significant stock drop on regulatory news. Most get dismissed or settled for nuisance value. Today's response gives ImmunityBio strong ammunition for a motion to dismiss. If you sold because of those lawsuit headlines, understand what you sold: a company whose founder quoted the government's own assessment, whose TV ad never aired, and whose corrective actions were already in place before the lawsuits were even filed. THE PICTURE Zoom out. - March 13: FDA issues Warning Letter about promotional language. - March 24: FDA Warning Letter reaches the market. Stock drops 21%. - March 26: IDMC confirms statistical power for the BCG-naive randomized trial. The data is real. - March 31: $100M financing closes. $75M non-dilutive from Oberland. PSS takes the dilution on himself. - April 1: Phase 3 sepsis trial filed. First non-cancer indication. 200,000 American deaths per year with no approved immunotherapy. - April 4: PSS posts the 2007 NCI Workshop findings. Hotchkiss 2014. Cordon-Cardo 2020. The thesis is public. - April 5: Saudi doctor posts about ANKTIVA availability at King Faisal Specialist Hospital. - April 6: ImmunityBio files its FDA response. Cites the NCI's own 2007 assessment as the basis for PSS's claims. The footnote. - April 15: The sepsis trial starts. The FDA is policing language. PSS is treating patients. The 2007 NCI Workshop is being used as both the investment thesis and the legal defense. And the molecule the government ranked #1 nineteen years ago is finally being deployed - not because the government built it, but because one man and his team did. The footnote is louder than the Warning Letter. Stay tuned.