Homie

@lafemme_nikkita @FDA They are silencing Dr Pat. It’s wrong. My husband and many others are alive today because of him. Until your life is turned upside down you have zero clue what it’s like. Get out of the way.

My husband is alive. I don’t care about your post. He was given 12 months 8 months ago. All you are showing me is the FDA doesn’t like a scientist to say his therapy works. All you are showing me is the FDA doesn’t want the public to know there is a different therapy available and are trying to silence Soon. Terminal patients don’t have time and shouldn’t have to wait for a bunch of academics to write their opinions for 20 years. If not for the “podcast” I wouldn’t have known about #ANKTIVA and NK cell therapy and my husband would be on his way out. President Trump signed right to try in 2018. The FDA needs to get out of the way.

My husband was diagnosed with glioblastoma and given 12 months to live. He has been on #ANKTIVA and PDL-1 NK infusions. He has now had 2 normal brain scans. The red tape to ground breaking therapy needs to be cut! The fact the FDA wrote Dr Pat a letter to silence him is a disgrace. People deserve to choose the path that makes sense to them. They deserve hope! They shouldn’t have to fail standard therapy to be given a chance at life. The first MRI is before, the 2nd after. @bullishbruk

@bullishbruk Yes, I’m happy he’s on his way out. Let’s hope for positive chance. Unleash #ANKTIVA and NK cell therapy.

FDA Hands Rare Voucher + Instant EAP to One Pancreatic Drug — Why Is IBRX Still Waiting? @US_FDA @DrMakaryFDA @realDonaldTrump FDA just issued “safe to proceed” for daraxonrasib Expanded Access — only 2 days after the sponsor asked. This is the same US company (Revolution Medicines) that got one of the first-ever Commissioner’s National Priority Vouchers (Oct 2025) for 1-2 month review. Phase 3 data (April 13, 2026): median OS 13.2 months vs 6.7 months chemo. Meanwhile @ImmunityBio @IBRX (another American company) has RMAT designation (Feb 2025) for Anktiva + CAR-NK in the exact same metastatic pancreatic setting (QUILT-88). Strong survival signals when lymphopenia reversed. No voucher. No EAP. Still waiting. Dr. Makary — how are these blanket discretionary decisions made? One gets $2B funding momentum + instant fast lanes. Small innovators get the full grind and may have to go abroad for traction. Patients with pancreatic cancer don’t have time for selective speed. Audit needed. GAO and OIG — review how the Commissioner’s voucher and EAP approvals are being handed out. Trump promised faster cures for ALL Americans. This isn’t it. Tagging for oversight: @RobertKennedyJr @SecKennedy @realDonaldTrump @DrPatrick @ImmunityBio @IBRX @DrOz @seanspicer @RepGuthrie @RepGriffith @USGAO @OIGatHHS @WhiteHouse @PressSec @amfAR @HIVgov @TheAIDSInst @TAGHIV @AIDSUnited @GMHC @PeterStaley @CMSgov @DrOzCMS @Spectral_MDAI #RealTimeTrials #MAHA #FasterCures #FDAReform #HIV #PatientFirst #IBRX #MDAI x.com/truedat999/sta… x.com/truedat999/sta… x.com/truedat999/sta… x.com/truedat999/sta…

$IBRX A woman walks into an oncology clinic with stage IV non-small cell lung cancer. She's given six to eight weeks to live. Her doctor prescribes Keytruda. Nobody mentions a number called LIPI. But the number on her chart, if anyone had calculated it, would have predicted exactly how this ends. 4.5 months. That was the median survival of patients with the worst lymphocyte profile on the drug she was about to receive. The number was published in October 2019 in JAMA Oncology. The fourth author was Richard Pazdur, the man running FDA's Oncology Center of Excellence. THE PAPER Pazdur and four colleagues had analyzed 3,987 patients across eleven international randomized trials submitted to FDA between January 1, 2013 and December 31, 2017. Their score combined two lab values: lactate dehydrogenase level (LDH) and derived neutrophil-to-lymphocyte ratio (dNLR). The denominator that mattered was lymphocyte count. Their conclusion: LDH and dNLR are important prognostic biomarkers irrespective of treatment modality for patients with metastatic NSCLC. Without lymphocytes, the patient dies. THE NUMBERS Read the Pazdur paper's own data, broken out by LIPI score: LIPI score 0 (good lymphocyte profile) on a checkpoint inhibitor: median overall survival 15.6 months. 95% CI 13.5-17.6. Hazard ratio 0.34. n=620. LIPI score 1 (intermediate): 8.9 months. 95% CI 7.9-9.7. Hazard ratio 0.59. n=583. LIPI score 2 (poor): 4.5 months. 95% CI 3.0-6.2. Hazard ratio 1.0 reference. n=165. The same LIPI score 2 patients on cytotoxic chemotherapy: 5.3 months median OS. 95% CI 4.3-6.3. n=184. Read those last two lines again. The LIPI 2 patient on a checkpoint inhibitor had an 0.8-month shorter median survival than the LIPI 2 patient on cytotoxic chemotherapy. Twenty-four days. Global log-rank P value across both arms: less than 0.001. The most expensive cancer drug in the world, performed worse than older cytotoxic regimens for the population whose lymphocytes had been depleted. Pazdur and his colleagues published that conclusion. The author affiliation listed on the paper: FDA's Oncology Center of Excellence and Center for Drug Evaluation and Research, Silver Spring, Maryland. Merck reported approximately $30 billion a year in checkpoint inhibitor revenue. Over the last five years that is roughly $150 billion. For LIPI 2 patients, the drug those billions paid for did less than chemo. THE ASK Pazdur closed his paper with one specific request: "As further prospective clinical trial information is collected, the role of the LIPI score can be better defined." He asked for a trial. Six years passed. THE GAP The paper didn't go away. It sat in JAMA Oncology, fully indexed, fully cited, fully available. The man who wrote it kept running FDA's cancer office until November 2025, when he was promoted to lead all FDA drug approvals as director of CDER. Six weeks later he retired, citing concerns about institutional dysfunction. He had served 26 years. Then in January 2026, someone read the paper and acted on it. Not the agency he ran. Saudi Arabia. WHAT SAUDI DID The Saudi Food and Drug Authority approved ANKTIVA for second-line metastatic NSCLC after reviewing 1.7 million pages of clinical data. The label, verbatim: "approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials." ALC is absolute lymphocyte count. The same biomarker Pazdur had identified as critical six years earlier. The Saudis didn't write a new theory. They acted on the theory the FDA's own senior cancer official had already published. The supporting trial: 150+ patients with second-line metastatic NSCLC who had failed prior checkpoint inhibitors. Median overall survival on ANKTIVA combined with a checkpoint inhibitor: roughly 21 months. Median OS on docetaxel monotherapy in matched historical comparisons: roughly 7 months. Triple. The patients eligible for the Saudi label are second-line lung cancer patients who relapsed after standard of care. Translation: patients whose Keytruda or Opdivo stopped working. The exact population in Pazdur's 2019 paper. THE PATIENT In April, the woman PSS treated three years ago - the one given six to eight weeks - was still alive. Her tumors were gone from her right lung and shrinking in her left. PSS played her testimonial on Sean Spicer's show on April 13, 2026. Three and a half years later, she was answering questions on television. APRIL 27, 2026 Two weeks later, the ClinicalTrials.gov registration for ResQ201A-NSCLC, NCT06745908, was updated. The trial expanded from two arms to four. Two cohorts. Cohort A experimental arm: ANKTIVA 1.2 mg subcutaneous + tislelizumab 200 mg IV + docetaxel 75 mg/m² IV. Cohort A control: docetaxel monotherapy. Cohort B (new on April 27) experimental arm: ANKTIVA 1.2 mg subcutaneous + the patient's previously failed checkpoint inhibitor + docetaxel 75 mg/m² IV. Cohort B control: docetaxel monotherapy. Total enrollment: 507 patients. Phase 3. Two-to-one randomization within each cohort. Primary endpoint: overall survival at approximately twelve months. Stratification factors per registry: geographical region, NSCLC histology (squamous vs nonsquamous), actionable genomic alteration status. Recruiting status: active. The population: patients who failed prior CPI. The biomarker: lymphocyte count. The trial design: prospective, randomized, multinational. The trial Pazdur asked for in 2019 was now registered. Later that same afternoon, Patrick Soon-Shiong posted Pazdur's paper on X. He said he'd just discovered it that day. He quoted Pazdur's own conclusion. He named the Saudi label. He closed with two words. Stay tuned. THE TIMELINE July 12, 2007: NCI, NIH, FDA, AACR, and ASH convened a landmark workshop. 124 candidate immunotherapy agents were submitted, winnowed to 30 for presentation, ranked into a top 20. They ranked IL-15 number one. Manuscript finalized October 4, 2007. October 2019: Pazdur and four colleagues published the LIPI paper. Lymphocyte count predicts survival. They asked for a prospective trial. April 2024: ANKTIVA, an IL-15 superagonist, was approved in the United States for one indication. Bladder cancer. November 2025: Pazdur named director of CDER, the broader FDA office overseeing all drug approvals. December 2025: Pazdur retired, citing concerns about institutional dysfunction. 26 years of service. January 2026: Saudi Arabia approved ANKTIVA for second-line NSCLC, citing ALC and overall survival explicitly. April 21, 2026: ANKTIVA commercially available in Saudi Arabia. First patients identified. April 27, 2026: The trial Pazdur asked for in 2019 - ResQ201A Cohort B - registered on ClinicalTrials.gov. Later that same afternoon, PSS surfaced the paper. Today is May 1, 2026. The trial is enrolling. The Saudi launch is live. The United States has not approved ANKTIVA for non-small cell lung cancer. STAY TUNED Pazdur didn't have to be convinced of the science. He wrote it. The country whose agency published the paper is not the country that acted on it. The trial Pazdur asked for is enrolling now. He retired five months before he could see it. Stay tuned was not a hint. It was a calendar.

#Anktiva @ImmunityBio @DrPatrick Cut the Red Tape on #Anktiva! $IBRX 😤

$IBRX While there’s a lot of noise about Keytruda, the real prize lies in the massive patent moat $IBRX has built. Thanks to @DrPatrick, @ImmunityBio holds U.S. Patent No. 9,925,247, which locks down the combination of ANKTIVA with any checkpoint inhibitor (anti-PD-1/PD-L1) through 2039. This is the future of immunotherapy. @LoriMills4CA42

Unleash #ANKTIVA and NK cell therapy! zerohedge.com/news/2026-04-3…

$IBRX In 15 years of investing, I’ve never craved a sudden bombshell PR to crush short sellers completely. Hoping shorts get zero chance to cover at all, then PSS drops huge news sending it straight to $15, then rockets to $20-$25 thanks to DTC

Sam Neill is now cancer-free and he credits a groundbreaking new therapy for it rollingstone.com/tv-movies/tv-m…

Just received my PET scan results and I’m over the moon to still be NEAD! No evidence of active disease, which means my treatment is keeping the cancer “asleep” 💫 As I come up to the four year anniversary of my Stage 4 metastatic breast cancer diagnosis, I feel incredibly grateful that my first line of treatment is still working. After a tough start to the year, with hospital stays, health setbacks and even having to come off my meds, the relief is overwhelming. I now just have to wait for the results of my neck MRI. I’m so thankful to the scientists, my oncologist, the medical community and especially my wonderful breast cancer nurses #ThankYouNHS At the same time, I’m very aware that not everyone gets the news they hope for, and that can make sharing moments like this feel bittersweet. Sending so much love for those facing difficult results right now 🫂 I’m going to head home, give my daughter a massive hug, and have a little celebration. Thank you for all the support 🩷 #LivingWithCancer

@Sergeynikon @ImmunityBio Agreed! Tides are turning

@XrpHomie @ImmunityBio This is the future. This is how cancer treatment will like globally soon

#Anktiva @ImmunityBio

“Jurassic Park” star Sam Neill says he is cancer free after five years of battling blood cancer. He's even planning to return to acting: “It’s time I did another movie.” At one point, his chemotherapy stopped working and “I was at a loss and it looked like I was on the way out, which wasn’t ideal obviously.., [but] I’ve just had a scan just now and there is no cancer in my body, that’s an extraordinary thing. I’m very, very excited that this can happen.” variety.com/2026/film/glob…

$IBRX is down today, but the biology behind NK cell therapy is still the same and still compelling. What’s happening here is NK cell–mediated serial killing. NK cells don’t need prior activation. They continuously scan, recognize abnormal tumor cells, and form an immunological synapse. Then the mechanism is very direct: • Perforin creates pores in the target cell membrane • Granzymes enter and trigger apoptosis One target is cleared, and the NK cell moves on repeating the process.Tumors adapt by reducing immune visibility, sending inhibitory signals, and building resistance to cell death. That’s why current approaches in this space focus on improving persistence and function like CAR-NK engineering and checkpoint modulation so this killing cycle can continue longer and more effectively in the tumor microenvironment. Short-term stock fluctuations aside, the underlying question is unchanged: can we make this natural system more efficient and durable in patients? credits: Backes et al., Journal of Biological Chemistry (2018), tomasgryzwa #immunitybio #medicine #immunology #sciencecommunication @bullishbruk @DrPatrick @LoriMills4CA42

#Anktiva @ImmunityBio You Can Do Alot Better ! Just speak With @DrPatrick 😤

$IBRX #zANKTIVA

Anktiva + TA-1 looking good. “Combined IL‐15 and Tα1 therapy reverses CD8+ T cell senescence” $IBRX @MartyMakary where we at? #d=gs_qabs&t=1777382117352&u=%23p%3DueKZPnU4MtAJ" target="_blank" rel="nofollow noopener">scholar.google.com/scholar?as_ylo…