Hacker(⚔️,⚔️)

🚨WATCH: $DRTS CEO after the stock surges on the Japanese approval news: We’re not looking to raise capital, we’re finishing FDA Phase 3 trial this quarter, Pancreas trial in H1 this year, GBM trial also this year, starting new trials and are forming strategic partnerships.

@Kekius_Sage @grok could this treat other cancers as well?

🚨 BREAKING: GBM - BRAIN CANCER CAN NOW BE TREATED BY ALPHA TAU (ISRAEL-BASED) THIS IS THE FIRST U.S. HUMAN TRIAL EVER

@OnlyGB They’ve already been moving nicely, so adding the macro probably won’t hurt📈

Why the FDA’s RWE shift matters for $DRTS (Alpha Tau) and $OBIO (Orchestra BioMed) The FDA has clarified it will accept de-identified real-world evidence (RWE)—from EHRs, registries, and claims—as part of marketing submissions, instead of requiring identifiable patient-level datasets. This is not a loophole. It’s a practical change that lowers friction while keeping evidentiary standards intact. What this enables (plain English): • Companies can use existing clinical-care data to show safety, effectiveness, and durability. • RWE can supplement trials or serve as external/historical controls, rather than forcing new randomized arms in every case. • Larger, longer follow-up datasets become usable without new patient enrollment. Why this speeds devices specifically for Alpha Tau and Orchestra: 1) Alpha Tau (Alpha DaRT – oncology, small/niche populations) • Alpha DaRT studies are typically single-arm, safety-focused IDE/pilot trials. • High-quality registry or claims data can act as contemporaneous or historical controls. • That allows FDA reviewers to assess treatment effect without adding a large randomized arm. → Less time recruiting rare cancer patients. Faster time-to-evidence. 2) Orchestra BioMed (BACKBEAT – pacemaker population) • BACKBEAT recently expanded eligibility in its pivotal program. • De-identified RWE can help demonstrate performance across broader real-world pacemaker cohorts while enrollment continues. • Large datasets support earlier safety and effectiveness confirmation, aiding labeling and review timelines. Safety and label expansion effects: • Rare adverse events, long-term BP effects (BACKBEAT), and durability of tumor control (Alpha DaRT) show up far sooner in large RWD sets than in long randomized follow-up. • That supports faster initial approval and quicker post-approval label expansions. Economic and operational impact: • Lower incremental trial cost (fewer sites, fewer new patients). • Shorter timelines for indications with scarce or fragile patient populations (GBM, pancreatic cancer, specific pacemaker subgroups). • Better capital efficiency per regulatory milestone. What this does not mean (important): • RWE must still meet FDA standards: data provenance, completeness, endpoint validity, and confounding control. Weak data won’t pass. • This does not automatically replace randomized trials. It works best as a supplement: external controls, safety, durability, and real-world performance. Why investors and management should care now: • Near-term de-risking for companies already in IDE/pivotal stages. Slow enrollment is a top regulatory risk—RWE directly attacks that. • Immediate tactical moves: – Lock in high-quality registries/EHR networks – Pre-specify endpoints and analysis plans – Engage FDA early on RWE design • FDA has clearly signaled willingness to accept de-identified, fit-for-purpose RWE. Bottom line: this change doesn’t lower the bar. It shortens the path for companies like Alpha Tau and Orchestra that already have credible clinical programs and limited patient pools.

@onlygb Hey Knights let’s try and help #HopeForJason⚔️ @SirPizzaSndwich @Mono513nft @LordOfETH @Addicted_2_MMA @NickLange_35 @mnorm2001 @CL0UGHK @AviaDanino @southside88pe @thekandyman_kan @bluellama00 @RealFrostdude @USAhunterCTH @pmixdorfcpa @LuckyApeJack @TexazK @SandmanJD

There’s hope for Jason! Amazingly the same week Jason Collins came out sharing he has GBM, heroically stating: “If that's all the time I have left, I'd rather spend it trying a course of treatment that might one day be a new standard of care for everyone” Is the same week Alpha Tau Medical, for the first time in history, successfully treated GBM with their revolutionary cancer treatment This can’t be a coincidence, if anyone knows Jason or could help get in touch with him, please reach out. Everyone else please help share so we could get the message to Jason🙏🏻 #HopeForJason

@onlygb Praying for Jason and his family along with all cancer patients #HopeForJason

@YardenBenJoseph @aviabelow You could be part of the solution.

Jews in America—you should be scared. And, yes, even to the Jews who have moved down to Florida. I don’t say that lightly. I don’t say it to panic you. I say it because it’s true. Kanye West, one of the most influential cultural icons in America today, just dropped a song with the chorus, and I quote, “Ni*gga, Heil Hitler” repeated over and over again. Yes, you read that correctly. A glorification of Hitler—mixed with the language of the streets, piped directly into the ears of millions of young Americans. And if that wasn’t sickening enough, he ends the song with an actual Adolf Hitler speech in the background of the music. This isn’t just Jew-hating antisemitism, this is a cultural bomb, normalizing genocidal hate speech against Jews, dressed up as “music,” and blasted across platforms with barely a whisper of pushback so far from the music industry. Imagine the outrage if another artist repeated the N-word with a white supremacist chant. But when it's about Jews? Silence. Or worse—applause. Let me be clear: I don’t want Jews fleeing America in fear. I want Jews coming home to Israel out of Jewish pride, a deep sense of faith in Hashem, and a sense of purpose, because Israel is our homeland, our story, and the future of our children. I want aliyah to Israel to be a calling, a fulfillment of a dream of our ancestors for thousands of years finally coming to fruition, not an escape. But to ignore the growing Jew-hatred around you is to walk blindly into danger. The ground is shifting, and fast. From college campuses where Jewish students are terrorized by Hamas-supporting mobs, to progressive movements that justify terror and demonize Israel, to celebrities like Kanye who spread raw Jew-hatred, now in music, with impunity, the picture could not be any clearer. How many signs does Hashem have to give us to wake up to the new reality. Nobody should still cling to the fantasy that America is safe for Jews forever—wake up. Times have changed, and they are just going to get worse. Kanye just rapped "Heil Hitler." To millions. I’m not telling you what to do. I’m asking you to see clearly. Ask yourself: if not now, when? Come home—not in fear, but in strength. But don’t ignore the warning signs that are flashing brighter every day.

@AlphaTauInsight Can’t wait for the next earnings call!

In biotech, capital is more than money — it’s momentum. With $36.9M in fresh funding, Alpha Tau Medical ($DRTS) can move faster, smarter, and stronger. In a race to redefine cancer treatment, speed matters. #biotech #oncology $DRTS

@AlphaTauInsight 🇺🇸🤝

In light of growing concerns around tariffs and global supply chains, it's worth noting that two-thirds of Alpha Tau’s manufacturing capacity is U.S.-based. This isn’t just good news for long-term profitability. It means life-saving cancer treatment can continue to be delivered reliably where it’s needed most. #biotech $DRTS

@AlphaTauInsight Amazing news and a lot of great work ahead for the great people working towards a cancer free world

Some cancers still have no cure. But this week brought another step forward — as Alpha Tau received FDA approval for its GBM trial, with other trials already underway and PMDA approval expected soon. One single session. 100% response so far. Real patients. Real hope. Wishing you a weekend filled with light, courage, and healing. #CancerResearch #Hope $DRTS

@AlphaTauInsight 🙏🏻

On this Doctors’ Day, we’re honored to recognize the physicians and medical centers helping to push the boundaries of cancer care. To the brilliant doctors advancing Alpha DaRT—from clinical trials to patient care—thank you for your vision, dedication, and life-saving work. With special thanks to: Dr. Robert Den • Prof. Aron Popovtzer • Prof. Yona Keisari • Dr. Tomer Harash • Prof. Michael Zelefsky • @joshuapalmermd And to many other physicians and clinical leaders making this possible. Gratitude also to the dedicated teams at: @OSUWexMed @GustaveRoussy …as well as the many hospitals, clinics, and research centers across 🇺🇸 🇯🇵 🇨🇦 🇫🇷 🇬🇧 🇮🇱 helping shape the future of Alpha DaRT. Your work is bringing new hope to patients and families worldwide. 💛 #DoctorsDay #Oncology #CancerCare $DRTS

@AlphaTauInsight 🙏🏻

Hope changes everything. Your share could change someone's life. 💛 #CancerAwareness #CancerTreatment $DRTS

@AlphaTauInsight Yessir hopefully soon!

Wishing everyone a peaceful and relaxing weekend💙 Looking forward to the day when every patient can enjoy weekends at home, with family, cancer-free. That future is closer than ever. 🌟 #WeekendVibes #Hope #FightingCancer #AlphaDaRT #MedicalInnovation #CancerBreakthrough #AlphaTauMedical $DRTS

@WilderWorld @opensea 🤝

@DegenHacker @opensea Real ones know 🤝

gm 🌊

@WilderWorld @opensea NFTs aren’t the story, you guys are amazing because of the team and community and what you’ve accomplished and what’s to come. The NFT aspect is important, technically the technology is the key, but it’s not the story. Don’t undervalue yourself WW, just keep delivering.

@opensea GM NFT believers

A note about all the talk of Football🏈 Being more popular than Football⚽️ On the official NFL Instagram account, the most liked post of Super Bowl Sunday, between champ posts, in game, BTS, families, Taylor Swift, the halftime show… Was a pic of Messi entering the stadium🐐

@Alanfalcon @LgDoucet The one concept I always preached was winning together I know the Q was for LG, but I felt like DL was trying to benefit off us instead of sharing the success with the community Not maliciously but foolishly Could’ve leaned in to scarcity and all and made much more $$$

@LgDoucet Curious! How would history be different if you'd been on the team?

while we're on the topic of partnerships in early 2021, everyone accused me of having a back room deal with top shot i wish, dude i even applied to work there like 3 times before I started TFM had to pitch them First Mint Fest before they finally came around 🤣