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$IBRX Update: The IDMC result is in. Yesterday I posted three possible outcomes for the BCG-naive trial. Here's what happened. The Result The Independent Data Monitoring Committee confirmed that N=366 is sufficient to detect clinically meaningful differences between ANKTIVA + BCG and BCG alone. No additional enrollment needed. The supplemental BLA is on track for Q4 2026. This is the "good case" from yesterday's post. The trial wasn't stopped early for overwhelming efficacy. But what PSS chose to publish alongside this announcement tells the real story. The Data They Buried in the PR The Phase 1b patients who started treatment in 2014 - nearly a decade ago: - 6 out of 6 evaluable patients (100%) still in complete remission - Median survival: 8.8 years - Ongoing bladder preservation to date And the 2023 interim analysis of the first 43 randomized patients "demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naive setting." You don't publish 8.8-year survival data and "demonstrated a difference" alongside a sample size confirmation unless you're signaling where the full data is heading. The Consistency Pattern - 2014: 9 patients in Phase 1b, 6 in long-term follow-up → 6/6 (100%) still in remission at 8.8 years - 2023: First 43 randomized patients → "difference in durable CR" between arms - 2026: 366 patients fully enrolled → IDMC confirms adequate power Same result at every scale. Nine patients. Forty-three. Three hundred sixty-six. Where This Fits - Bladder CIS: FDA approved (April 2024) ✓ - Papillary: NCCN 2A + sBLA resubmitted ✓ - BCG-naive: IDMC confirmed, BLA Q4 2026 ✓ ← JUST CONFIRMED - Global: 34 jurisdictions ✓ - NK cell platform: Leonardo assembling ✓ The warning letter dominated the headlines this week. This press release will dominate the story this year. The randomized data the FDA asked for is coming. The 8.8-year durability says it's going to be worth the wait.

$IBRX While the market panics over a warning letter about a podcast, @DrPatrick just quietly dropped the most important clinical update of the year. 3,503 views. This deserves more. What Happened The BCG-naive randomized trial (QUILT-2.005) hit its 50% evaluable milestone - meaning half of all 366 enrolled patients have now reached a time point where their efficacy can be assessed. This triggered an Independent Data Monitoring Committee (IDMC) review. Why It Matters The IDMC is an independent external panel that can see unblinded data from both arms, evaluating whether N=366 has enough statistical power to detect clinically meaningful differences between ANKTIVA + BCG versus BCG alone. This is a RANDOMIZED CONTROLLED trial. Two arms. Head-to-head. The exact study design the FDA has been asking for. The warning letter specifically called the single-arm QUILT-3.032 data "uninterpretable" without a comparator. This trial has the comparator. What the IDMC Could Determine - The 366 patients are sufficient - BLA stays on track for December 28, 2026 - More patients needed - BLA timeline extends - Or, in the best case: the treatment effect is so strong that continuing to randomize patients to BCG alone would be unethical PSS: "Stay tuned." The Bigger Picture BCG-naive is the market that changes everything. The current FDA-approved indication (BCG-unresponsive CIS) covers roughly 8,000 patients per year. BCG-naive covers 30,000-40,000. This trial is the bridge to the largest expansion opportunity in the pipeline. Prior non-randomized data showed 85% complete response with ANKTIVA + BCG vs 57% with BCG alone at six months. Statistical significance at nine months. Now the randomized trial is generating the data to confirm it. Where This Fits in the 3-Year Plan - Bladder CIS: FDA approved (April 2024) ✓ - Papillary: NCCN 2A + sBLA resubmitted (March 2026) ✓ - YOU ARE HERE: BCG-naive: 366 enrolled, IDMC triggered, BLA Dec 2026 - Global: 34 jurisdictions ✓ - NK cell platform: Leonardo assembling, M-ceNK Phase 2 ongoing ✓ The warning letter is about how you promote a drug. This trial is about proving it works in the biggest market yet.

$IBRX While the market digests a warning letter about a podcast (corrective actions already underway - see my prior post), PSS just showed where the 3-year plan actually stands. What's Been Delivered - Bladder cancer CIS: FDA approved (April 2024) - Papillary expansion: NCCN Category 2A + sBLA resubmitted to FDA (March 2026) - Global approvals: 34 jurisdictions - US, UK, EU (30 countries), Saudi Arabia, Macau - Saudi lung cancer: first-in-world NSCLC approval with checkpoint inhibitor - European launch: Accord Healthcare partnership across 30+ European countries - Revenue: 700% year-over-year growth, 87% compound quarterly unit growth - Lynch Syndrome prevention: NCI trial fully enrolled (138 patients), first biological data confirms ANKTIVA raises immune markers - Cancer vaccines: HHS and NCI formally backing $200M in trials using ANKTIVA's platform - NK cell manufacturing: up to 5 billion cells per collection, 8-10 doses per patient, 12-day turnaround, zero cytokine storm What Just Dropped PSS posted the first photo of NANT Leonardo - the AI-driven robotic cell therapy manufacturing system being assembled right now. M-ceNK Phase 2 clinical trials ongoing. Process development from 60+ healthy volunteers and cancer patients complete. The system is "landing soon." This is the "World Bank of NK Cells" - off-the-shelf immune cell therapy manufactured by robots, stored frozen, available to any patient without donor matching. What's Coming - BCG-naive BLA: targeted December 28, 2026 (4-5x the current bladder market) - Papillary FDA filing decision: ~60 days from March 9 resubmission (estimated ~May 2026) - NANT Leonardo deployment: "landing soon" - NCI efficacy data: AACR IO presentation - More international approvals: "multiple countries have reached out" The Pattern Every quarter, another step lands. Not promises - execution. The warning letter is about how you promote a drug. The 3-year plan is about how you build a platform. One is being fixed. The other is on schedule.

Good question. The papillary sBLA was resubmitted on March 9, 2026 after the original received a refuse-to-file (RTF) in May 2025. After an RTF resubmission, the FDA has 60 days to decide whether to accept it for review (or refuse again). That puts the filing decision around early May 2026. If accepted: Standard review: 10 months from filing = ~March 2027 Priority review: 6 months from filing = ~November 2026 ANKTIVA has Breakthrough Therapy and RMAT designations for this indication, and the FDA invited the resubmission at the January 20, 2026 Type B meeting. Those are positive signals for the timeline but the FDA hasn't disclosed the review classification yet. Separately, the BCG-naive BLA is targeted for submission December 28, 2026.

@ActionFixesFear Nice! Can you help remind us how many days the FDA must make the decision after getting the resubmission of supplemental Biologics License Application (sBLA) to the U.S. FDA in March 2026 for ANKTIVA® (N-803). Thanks!

$IBRX The stock dropped 21%. The website is already corrected. The podcast is down. I checked every source cited across all three FDA communications myself. Already Corrected: The Website (Flagged Sept 2025 + Jan 2026) The FDA's two prior letters targeted the anktiva.com website for promoting 84% cystectomy avoidance at 36 months and 99% disease-specific survival from the QUILT-3.032 trial. The FDA's position: this is a single-arm study with no comparator arm, making these time-to-event endpoints uninterpretable. The numbers are real. Promoting them as proven drug efficacy without a control group is not. Both pages have been corrected. The 84% and 99% claims are gone. The HCP page now shows the approved endpoint: 62% complete response with 53+ month duration of response. The consumer page shows 71% complete response. Both include full risk disclosures and the intravesical-only administration warning. Already Removed: The Podcast (Flagged March 2026) "Is the FDA BLOCKING Life Saving Cancer Treatments?" has been taken down. The immunitybio.com page returns a 404. Still Unknown Whether the DTC TV advertisement (reference US-ANK-250065-v1) is still running on broadcast. Corrective Plan Due April 3 ImmunityBio has approximately until April 3 to submit its formal corrective plan. Three issues flagged across three communications over seven months. All three are being addressed. The science, the 34 international approvals, the NCCN Category 2A listing, and the pending FDA submissions remain exactly where they were before the letter.

$IBRX For those asking about the podcast still being on YouTube - the FDA warning letter cited the podcast because ImmunityBio hosted it on their corporate website without required risk disclosures. That's what made it a promotional violation. The same content living on YouTube or other third-party channels is not under the company's FDA compliance obligations. What matters is that it's off immunitybio.com. It is not there anymore.

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$IBRX The FDA issued a warning letter to ImmunityBio on March 13. I cover catalysts and risks. Here's what this actually means. What It Is The letter comes from OPDP - the Office of Prescription Drug Promotion. This is the division that polices marketing. Not the division that reviews or approves drugs. A TV ad and a podcast titled "Is the FDA BLOCKING Life Saving Cancer Treatments?" made claims beyond ANKTIVA's approved label. Nine violations including promoting for lung cancer, calling it a cancer vaccine, showing the wrong route of administration, and presenting zero risk information in the podcast. What Makes It Serious FDA sent two prior letters to subsidiary Altor BioScience (September 2025 and January 2026). Both were apparently ignored. This warning letter is the escalation. ImmunityBio has 15 working days from receipt to respond with a corrective plan. The two ignored letters are the worst part. A single warning letter is routine in pharma - Pfizer, Bayer, Pacira, Intercept have all received them. Three communications with apparent non-compliance is a pattern, and patterns get escalated. What It Does NOT Affect - ANKTIVA's FDA approval (BLA 761336 - untouched) - NCCN Category 2A listing for papillary disease - 34 international approvals (US, UK, EU, Saudi Arabia, Macau) - Pending papillary sBLA or BCG-naive BLA submissions - The QUILT trial data - NCI's independent validation of the science OPDP is a marketing compliance office. It has no authority over drug approvals. The Paradox On the same week this letter was issued: - NCCN gave ANKTIVA Category 2A for the exact indication the FDA refused to file - HHS and NCI announced $200M behind cancer vaccine trials built on ANKTIVA's platform - Macau became the 34th jurisdiction to approve ANKTIVA - NCI published first biological data from the Lynch Syndrome cancer prevention trial The FDA's promotion office says stop calling it a cancer vaccine. The FDA's parent department just put $200 million behind cancer vaccine trials using the same molecule. Bottom Line The drug isn't the problem. The promotion is. OPDP warning letters are resolved by pulling the ads, hiring compliance counsel, and submitting a corrective plan. Most never result in enforcement. But ignoring two prior letters was a mistake, and the marketing team needs to course-correct immediately. The science speaks for itself. Let it.

$IBRX The Wall Street Journal just broke an exclusive: the Trump administration is launching a $200 million cancer vaccine initiative through the Department of Health & Human Services and the National Cancer Institute. Then @DrPatrick tweeted something that deserves a closer look The Government Announcement HHS (the department that oversees the FDA) and NCI (the government's premier cancer research institute) are creating a $200 million public-private partnership to fund clinical trials of vaccines that prevent cancer from recurring in high-risk patients. The Wall Street Journal has the exclusive. What PSS Just Said His tweet: "We have spent the past decade collaborating with 2 amazing thought leaders at the National Cancer Institute in the field of cancer vaccine, Dr James Gulley and Dr Jeffrey Schlom. Together we have completed Phase 1 & 2 trials across multiple tumor types showing how our Adeno vaccine plus Anktiva generates tumor specific T cells." Phase 1 and 2 completed. Multiple tumor types. Tumor-specific immune cells generated. With government scientists. Over a decade. The government just committed $200 million to build what PSS says his team already built. With the government's own researchers. The Lynch Syndrome Data The randomized trial to prevent cancer in Lynch Syndrome patients (1 in 278 Americans - over a million people) is fully enrolled with 138 subjects. PSS says the early data shows ANKTIVA plus the cancer vaccine increases immune cells in these subjects - even in patients aged 65. Cancer prevention in patients who don't have cancer yet. Using a drug the market prices as a bladder cancer treatment. The Paradox HHS oversees the FDA. The same department that just endorsed cancer vaccine trials using ANKTIVA is the parent of the agency that issued a refuse-to-file on ANKTIVA's papillary bladder cancer indication. One arm of the government: fund it, expand it, $200 million behind it. The other arm of the government: we refuse to accept the submission for review. The National Cancer Institute validates the science. The FDA career staff block the drug. Same government. Same department. Same molecule. 168K Views PSS's tweet hit 168,000 views. The Wall Street Journal is covering cancer vaccines. The government's cancer institute is validating the platform. The government's health department is funding the category. The mainstream financial audience is seeing ImmunityBio connected to government-backed science for the first time. The market prices a bladder cancer drug at around $8.50. The government just put $200 million behind the platform PSS built with their own scientists over a decade. Connect the dots.

Global expansion-first approval in Asia!! Anktiva now approved in Macau, China today. Paradigm change of treating the immune system unstoppable.

@DrPatrick from $IBRX just tweeted about Lynch Syndrome trial data from the National Cancer Institute. Most people will read "exciting analysis" and keep scrolling. Here's what he actually told you. This Isn't A Cancer Treatment Trial. It's A Cancer Prevention Trial The subjects don't have cancer. They have Lynch Syndrome - a genetic predisposition that dramatically increases cancer risk. The trial is testing whether ANKTIVA plus a cancer vaccine can prevent cancer from ever developing. 138 patients. Randomized. Placebo-controlled. Run by the National Cancer Institute - Dr Jeff Schlom's team. Not ImmunityBio's own study. Independent. The gold standard. The first 20-subject biological analysis just came back. NCI confirmed ANKTIVA stimulates immune response by raising ALC - Absolute Lymphocyte Count. Your immune army. The Line That Changes Everything "As we age the baseline ALC is low but Anktiva changes that level." Not as we get cancer. As we AGE. Every human being's immune system declines with age. Lymphocyte counts drop. The body becomes vulnerable to infections, cancers, and chronic disease. PSS is saying ANKTIVA reverses that decline. NCI data confirms it. 52 Million Americans PSS references the JAMA paper showing 1 in 5 Americans suffer from lymphopenia - low lymphocyte counts - with significantly shorter lifespan. That's 52 million people. Not cancer patients. Americans with aging immune systems. If ANKTIVA treats lymphopenia as a standalone condition, the addressable market isn't bladder cancer (84,000/year). It isn't even all cancers (2 million/year). It's immune decline across an aging population. Tens of millions of people. Three Things The Market Doesn't See The market prices IBRX as a bladder cancer drug. This one tweet confirms three things that aren't in any analyst model: 1. Cancer prevention platform. ANKTIVA + cancer vaccine preventing cancer in genetically predisposed patients. If this works, it's a new category of medicine. 2. Immune restoration drug. NCI data showing ANKTIVA raises ALC in aging populations. Not cancer patients - people whose immune systems are declining with age. 3. Lymphopenia treatment. 52 million Americans. JAMA-validated condition with mortality implications. No approved treatment exists. The bladder cancer revenue ($113M and growing 700%) is what the market sees. Cancer prevention, immune restoration, and lymphopenia treatment are what the market doesn't see. NCI is generating the data for all three. Independently. PSS ended with five words: "The cancer vaccine trials are underway!" The market is pricing a bladder cancer drug. The NCI is validating a platform that could treat aging itself.

@DrPatrick from $IBRX just tweeted about the NCCN papillary listing. Most people read "pleased with the guidelines" and moved on. But the second sentence is the one that matters. "Now next step is to provide BCG for all patients who could benefit in bladder cancer." Here's what he just told you. The Ladder $IBRX isn't a one-indication story. It's a three-step takeover of the entire bladder cancer market. Each step is bigger than the last. Step 1 - Done. BCG-unresponsive CIS. FDA approved April 2024. The narrowest label - patients with CIS who failed BCG and refuse or can't have surgery. The smallest patient pool. This is where the $113M in FY2025 revenue came from. Step 2 - Just happened. BCG-unresponsive papillary-only. NCCN Category 2A, March 2026. The FDA refused to file the sBLA for this indication. PSS went around them - submitted data to NCCN, got Category 2A (uniform consensus). The sBLA was resubmitted to FDA March 9. This roughly doubles the eligible BCG-unresponsive patient population. Step 3 - December 28, 2026. BCG-naive high-risk NMIBC. This is what PSS means by "all patients who could benefit." Not patients who failed BCG - patients who haven't tried it yet. First-line treatment. The trial data: 84% complete response vs 52% for BCG alone at 9 months (p=0.0455). The BLA targets December 28, 2026. The Numbers About 84,500 Americans are diagnosed with bladder cancer each year. Roughly 75% are NMIBC - that's about 63,000 patients. The high-risk subset eligible for BCG is the largest single group. Steps 1 and 2 combined address the BCG-unresponsive population - the patients who already tried BCG and it failed. Step 3 addresses everyone else. The entire high-risk NMIBC population. "All patients who could benefit." The Hockey Play The FDA was the goalkeeper. They blocked the papillary shot with a refuse-to-file. PSS didn't shoot again at the same spot. He passed the puck behind the goalkeeper through NCCN - Category 2A. Now he's pointing at the wide-open net: BCG-naive. December 28. "All patients who could benefit." That's not a vague aspiration. That's a BLA filing date and a trial with 84% complete response. He told you where the puck is going. The only question is whether you're positioned before it gets there.

$IBRX spiked above $9 on the NCCN Category 2A listing, then closed red. If you're worried, read this. If you've seen this before, you already know what comes next. The Pattern That Repeats Across Every Heavily Shorted Stock There is a playbook that shorts run on catalyst days. It works like this: The news drops. Retail buys the spike. Shorts sell aggressively into the momentum - not because they believe the catalyst is bad, but because they NEED to prevent a sustained breakout. A sustained move triggers margin calls. Margin calls trigger forced covering. Forced covering triggers a cascade. So they throw everything they have at catalyst days to keep the price contained. The stock goes red. Retail sees red and panics. "Even good news couldn't move it." Shorts win the day. But the catalyst doesn't expire at market close. The revenue compounds. The next catalyst loads. And eventually, the shorts run out of ammunition. Tesla. June 2019. Record deliveries reported. Stock dropped 1.5%. Shorts celebrated. Tesla was at $178. The deliveries kept growing. The revenue kept compounding. Twelve months later: $2,213. Every catalyst day between $178 and $2,213 had the same pattern - spike, fade, sometimes red. The shorts sold into every single one. They lost $40 billion. GameStop. January 13, 2021. Ryan Cohen joins the board. Stock spikes to $31, closes at $19.94. Red candle on a catalyst day. Shorts doubled down. Two weeks later: $483. Melvin Capital lost 53% in one month and closed permanently. Volkswagen. October 2008. Porsche announces 74% ownership. The stock actually DROPPED 6% the next morning as shorts sold into it. Then it went from 210 to 1,005 euros in 48 hours. $30 billion in short seller losses. ImmunityBio. February 18, 2026. European Commission approves ANKTIVA across 30 countries. Stock surges 42%. Then pulls back over the following days. What happened next? Saudi lung shipments cleared. EAU26 showed HR 0.4. NCCN listed papillary with Category 2A. Each pullback after each catalyst was the shorts buying time they don't have. What Actually Happened Yesterday The NCCN gave ANKTIVA Category 2A for papillary-only bladder cancer. That's their highest standard recommendation - uniform consensus that the intervention is appropriate. This is the indication the FDA refused to file on. The NCCN reviewed the same data and gave uniform consensus. Starting today - permanently - every urologist in America can prescribe ANKTIVA for papillary disease with full NCCN guideline backing. Every major insurer and Medicare uses NCCN Category 2A as the standard for reimbursement decisions. Every new patient prescribed is revenue that didn't exist last week. This doesn't reverse at 4 PM. It compounds. The Math That Shorts Can't Escape 132 million shares short against ~160 million tradeable. The NCCN just expanded the addressable prescribing base. The sBLA was resubmitted to FDA on March 9. The BCG-naive BLA targets December 28. Saudi Arabia is shipping. Europe just launched. Six more catalysts are loaded. Each catalyst adds prescribing volume. Each new patient adds revenue. Each revenue beat makes the short thesis weaker. Each weaker thesis makes it harder to borrow. Each harder borrow raises the cost. The math compounds against them exactly the way it compounded against Tesla shorts. The Daily Candle Doesn't Matter. The Trajectory Does. Red days after catalysts are the shorts' oxygen. The catalysts are the fire. Eventually the oxygen runs out. The stock closed red yesterday. The NCCN Category 2A listing is permanent. The question isn't about today's candle. It's about how many red days the shorts have left before the math catches them. The trap is tightening.

$IBRX shorts right now

"You misread. We said the FDA refused to file - past tense, referring to the original RTF from May 2025. We then said IBRX resubmitted on March 9, 2026. That resubmission hasn't been accepted or rejected yet - it's pending. The point is: the NCCN just listed ANKTIVA for the same papillary indication that the FDA refused to file on last year. Two different events, two different timelines. The RTF was May 2025. The NCCN listing is March 2026. The resubmission is pending.

@ActionFixesFear FDA didn’t issue Refuse-To-File for the resubmitted sBLA.

Two days ago I published S15: The Trap. Episode 7 listed seven catalysts loaded against $IBRX short sellers. The first one just fired. The FDA Said No. The NCCN Just Said Yes. NCCN updated Bladder Cancer Guidelines to Version 1.2026. ANKTIVA + BCG is now listed as "Other recommended" for BCG-unresponsive papillary-only NMIBC - the exact indication the FDA issued a refuse-to-file on. What this means: The NCCN is the gold standard for oncology treatment decisions in America. NCCN listings are the standard most major insurers and Medicare use for reimbursement decisions. Physicians can now prescribe ANKTIVA for papillary disease with NCCN guideline backing - regardless of what the FDA does with the sBLA. PSS gave a UroToday lecture titled "Papillary NMIBC Treatment Guidelines Gap." He called out that pembrolizumab and nadofaragene were listed for papillary with weaker data while ANKTIVA was excluded. That gap just closed. The FDA issued a refuse-to-file on the papillary submission. The NCCN reviewed the data and listed it. ImmunityBio resubmitted the sBLA to FDA on March 9. The NCCN just gave them cover. One down. Six loaded. 132 million shares short. The dominoes are falling. The trap is tightening.

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$IBRX S15: The Trap | E8: The Question You are short 132 million shares of a company where: The founder controls 66.3% and hasn't sold a single share - not at $5, not at $8, not at $12.43. The true tradeable float is roughly 160 million shares - barely more than your entire short position. Revenue grew 700% year over year. Thirty-three countries approved the drug. The National Cancer Institute independently validated the next platform. A hazard ratio of 0.4 was just presented at Europe's largest urology conference. Five binary catalysts are loaded in the next nine months. A convertible note can compress the float further at any time. Tesla shorts said the same thing you're saying now: the fundamentals don't justify the price. They lost $40 billion. The stock is $8.39 at the moment of writing. The trap is set.

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@DrPatrick just shared this. A physician told the Senate that "something has gone seriously wrong in the FDA." He's not talking about $IBRX. He's talking about the entire agency. Here's why that matters right now. --------------------------------- Part One: The Hearing --------------------------------- February 27, 2026. Senate Special Committee on Aging. Dr. Jeremy Schmahmann - neurologist, founding director of Massachusetts General Hospital's Ataxia Center - testifies under oath. His words: "Something has gone seriously wrong in the FDA." And: "I started dealing with the FDA committee in 2023. When I talked in my testimony about talking to a brick wall, that was the last administration. The FDA seems to be carving their own path, regardless of who's in Congress or the White House." The numbers behind the testimony: - 23 rare-disease therapy rejections since 2025 - many reversing the FDA's own prior decisions - 65% fewer advisory committee meetings in the past year versus 2024 - Late-stage changes to clinical study design expectations - Failure to consider real-world evidence and patient experience Senator Gillibrand: "This is heartbreaking for patients." This isn't a CEO complaining about his own drug. This is a Harvard-affiliated physician, under oath, in front of a Senate committee, saying the agency responsible for approving lifesaving therapies has stopped functioning. New leadership. Same wall. ----------------------------------- Part Two: Now Consider This ----------------------------------- There is a drug called ANKTIVA. It is approved in 33 countries. The FDA approved it for bladder cancer in April 2024 and validated its mechanism of action in the package insert - Section 12.1 confirms ANKTIVA activates T cells and NK cells. Over 13,000 American patients have requested access to this drug for cancers beyond bladder. The company submitted for a second bladder cancer indication. The FDA issued a refuse-to-file letter - on the same drug whose mechanism it already validated. At EAU26 this week in London, independent German clinicians presented real-world evidence showing ANKTIVA patients have a 60% lower risk of cancer returning versus standard of care. Saudi Arabia approved it for lung cancer. Europe approved it across 30 countries. Multiple other nations are requesting dialogue. And in America, the agency that Dr. Schmahmann just described as "talking to a brick wall" holds the keys. PSS didn't mention ANKTIVA. He didn't mention ImmunityBio. He shared a Senate hearing and wrote five words: "The inertia despite new leadership." Thirty-three countries approved the drug. The FDA approved the mechanism. Thirteen thousand Americans requested access. The wall is still there.

Love the animation! Killing the tumor from the outside in and releasing the antigens. Special forces