Zu Besuch im Abstimmungsstudio der SRG – am Tag, an dem über die Halbierung der SRG abgestimmt wird. https://www.nzz.ch/schweiz/allwae-wie-das-srf-team-hinter-den-kulissen-auf-den-abstimmungssieg-reagiert-ld.1926643?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b884
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South Korea: -7.7%
Japan: -6.4%
Vietnam: -6.9%
Philippines: -5.3%
Taiwan: -5.1%
Indonesia: -3.5%
Australia: -3.4%
India: -3%
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An excerpt : When you can't rebut the facts, pharma bros count em dashes.
Sarepta and Duchenne Muscular Dystrophy
To understand what Prasad walked into at CBER, you have to understand what his predecessor Peter Marks had already done there — and what Marks’s predecessor Janet Woodcock had done before him. The Sarepta story is not one bad decision. It is a decade-long institutional pattern of FDA leadership overruling its own scientific staff to approve drugs that didn’t work, under pressure from patient advocates that the companies themselves helped organize and fund.
It starts with Exondys 51 (eteplirsen), approved September 19, 2016. Sarepta applied for accelerated approval based on the claim that the drug increased dystrophin expression in boys with a specific Duchenne variant. The FDA scientific advisory committee reviewed the data and found it inadequate — voting 7-3 against full approval and 7-6 against even accelerated approval. Reviewers cited poor quality biopsy data, no adequate controls, no evidence of clinical benefit, and a dystrophin expression assay that was later independently debunked by the FDA’s own analysts. Committee members also noted on the record the “intense and near-incessant pressure from a large public audience” packed with patient advocates, all of whom testified in favor of approval. Janet Woodcock, then Center director, approved the drug anyway. FDA reviewers responded by filing a formal complaint — a virtually unprecedented act — noting this could be “the first time a Center Director has overruled a review team on a question of whether effectiveness has been demonstrated.” FDA Commissioner Robert Califf issued a 126-page report acknowledging the problems but declined to overrule Woodcock, instead mandating a confirmatory dose-finding study using the North Star Ambulatory Assessment as primary endpoint, which he said would settle the question of whether the drug worked.
That study, the MIS51ON trial, was started in 2020 and as of this writing remains active with no results reported — a decade after the drug was approved. But here is the detail that makes the entire exercise even more farcical: MIS51ON has no placebo arm. It compares higher doses of eteplirsen against the already-approved 30mg/kg dose. It cannot, by design, answer whether eteplirsen beats placebo. It cannot confirm clinical benefit. When it eventually concludes, the foundational question Califf said would be settled — does this drug actually work? — will remain exactly as unanswered as the day Woodcock approved it. Exondys and three successor drugs remain on the market, all approved substantially on the basis of dystrophin protein expression levels. Whether any of them meaningfully alter the natural history of Duchenne muscular dystrophy remains, in the precise scientific sense of the word, unknown.
This is the context in which Catherine Collins stood up at a 2024 patient conference and confronted a Sarepta representative directly: five drugs on the market under accelerated approval, confirmatory trials years overdue, a $3.2 million-per-injection gene therapy being promoted on the basis of a failed primary endpoint trial. “You don’t think you can do a little more effort, and give us a little bit more information?” she told them. “You’re just... taking money.” The video is worth watching. As I've documented in detail prior Elevidys was rinse and repeat.
The Phase 3 EMBARK trial — the definitive test of whether the gene therapy actually improved motor function — failed its primary endpoint. North Star Ambulatory Assessment scores showed no significant improvement over placebo. FDA staff again recommended against approval. Peter Marks, who had taken over CBER from Woodcock, overruled them, granting accelerated approval in June 2023 based on micro-dystrophin expression as a surrogate. He then expanded the approval in June 2024 to include all patients four and older, ambulatory or not — including older, non-ambulatory teenagers who had been explicitly excluded from the original trial that formed the basis for that approval.
Then boys started dying.
The toxicity should not have come as a surprise. The AAVrh74 adenoviral vector used to deliver the therapy was known to be highly immunogenic, triggering immune responses that caused severe liver injury requiring heavy steroids and immunosuppressive agents. Two of the teens who died were older, non-ambulatory patients — precisely the group Marks had added to the label on the thinnest of evidence, and precisely the group excluded from the trial. A third death, a 51-year-old man in a separate Sarepta trial using the same vector, was reported to the FDA on July 3, 2025. CEO Doug Ingram had known about it before the company’s June 16 earnings call. He made no mention of it. When later asked why, Ingram explained the death was “neither material nor central to the topics at hand.”
Prasad, now running CBER, responded on July 18 by requesting that Sarepta voluntarily halt Elevidys shipments and pause trials. Sarepta refused — publicly, in a letter stating it saw “no new safety signal in the approved population” and attributing the deaths to “unique patient conditions.” They eventually capitulated on July 21. But behind the scenes, the machine was already in motion.
Laura Loomer — the MAGA influencer who had previously claimed the scalps of several Trump administration officials for insufficient political loyalty — published a hit piece painting Prasad as a “progressive leftist” sabotaging the “Make America Healthy Again” agenda. She cited his past public admiration for progressive politicians and accused him of obstructing Right to Try. The piece arrived with suspiciously precise timing and suspiciously detailed FDA process knowledge for someone with no obvious reason to be tracking CBER’s drug review calendar. The fingerprints of biotech interests protecting a $3.2 million-per-injection franchise were not difficult to find.
The irony was almost too rich: the same MAGA ecosystem that had spent years insisting mRNA COVID vaccines were dangerous gene-modifying experiments was now furious that a regulator was asking hard questions about an actual gene therapy linked to multiple deaths in young boys.
Money printer warming up...
*SUMITOMO CHEMICAL ASIA DECLARES FORCE MAJEURE ON DELIVERIES
Wang's case shows how politicized medicine has become. We need environments where data comes before ideology, ensuring scientific inquiry doesn't cost you your career.
lol.
Remember, its all about the patients.
I do love it when academics who literally will try to end your career for disagreeing with them give lectures about civility and divisiveness on here.
Fun fact: In 1996, Barack Obama won his first elected office (Illinois state Senate) by throwing all of his opponents off the ballot.
One of his tactics for disqualifying them was to challenge signatures on his opponents' petitions by married women who signed using the wrong name.
Happy International Women's Day.
https://www.wsj.com/articles/SB121918996082755013
R to @anish_koka: anishkokamd.substack.com/p/a…
In 2019, cardiologist Norman Wang published a peer reviewed paper on affirmative action in medicine. He argued that the institution of medicine was violating civil rights law by discriminating against Asians/Whites/Males.
Wang was a well liked/respected highly published EP fellowship director at the time. Dr. Katie Berlacher, a good friend of Dr. Gulati, and fellowship director of the same cardiology program took to twitter to call him a racist. In the next few days he was demoted from being fellowship director, banned from future contact with trainees, and his paper retracted.
I wonder if Dr. Gulati finds what happened to Dr. Wang.. divisive ?
Link to full story in reply.
Der Gewerbedirektor hat am Abstimmungssonntag schon weitere Abgabensenkungen für KMU gefordert, die Linke will mehr Geld für die SRG. https://www.nzz.ch/schweiz/der-kampf-um-das-medienhaus-geht-nach-dem-volksnein-zur-srg-initiative-gleich-weiter-ld.1927713?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b883
Which Asian countries are most exposed to rising oil prices: China least, Singapore the most
🛢📈KUWAIT HALTS OIL PRODUCTION DUE TO THE CLOSURE OF THE STRAIT OF HORMUZ
#OOTT
(https://mktnews.com/flashDetail.html?id=019cd097-7551-7001-80c6-4e47a1191975)
Bereit für den Schwarzen Montag?
David Beckham hat es vorgemacht, Ronaldo und Co. ziehen nach: Fussballstars haben ihren eigenen Sport als Investment entdeckt. Doch längst nicht immer sind sie damit erfolgreich. https://www.nzz.ch/sport/fussball/fussballstars-als-unternehmer-ronaldo-kauft-klubanteile-ld.1927544?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b882
Yo, und alle Iraner bedanken sich ganz herzlich für Freiheit und Demokratie!
...not
Successful hospitals hire teams of medical coders. Why you ask ? @DrDiGiorgio
Die Stimmberechtigten haben am Sonntag im Sinne von Parlament und Bundesrat abgestimmt. Einen Denkzettel gab es für die SP und die Grünen. Der Klimafonds wurde in fast allen Gemeinden abgelehnt. https://www.nzz.ch/schweiz/nein-zur-heiratsstrafe-vertrauensbeweis-fuer-die-srg-ein-abstimmungssonntag-ohne-grosse-ueberraschungen-ld.1928286?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b881
In a crisis gold usually sells off as people sell a liquid asset to meet margin calls. Wait 1-2 weeks and then gold surges. I'm happy to see gold holding above $5k. This is actually bullish.
Der 56-Jährige hat nie ein öffentliches Amt bekleidet, unterhält aber enge Verbindungen zu den Revolutionswächtern. Die Wahl des Hardliners zeigt, dass Teheran trotz Krieg auf Kontinuität setzt. https://www.nzz.ch/international/vom-geheimnisvollen-strippenzieher-zum-iranischen-revolutionsfuehrer-mojtaba-khamenei-folgt-auf-seinen-vater-ld.1928338?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b880
Fake issue/"crisis" alert.
Theres nothing to "reclaim"- AI is primarily affecting knowledge workers and the reality is the AI datacenter build out is a boon to skilled labor.
Texas cant even find enough electricians and skilled workers to build the datacenters.
AI power is beholden to manpower and energy.
Die Polizei ermittelt unter anderem wegen des Verdachts auf Terrorismus. https://www.nzz.ch/international/explosion-in-der-us-botschaft-in-oslo-es-koennte-ein-vorsaetzlicher-anschlag-gewesen-sein-sagt-die-polizei-ld.1928276?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b87f
My own photo finish 27 years ago as I anchored our mile relay. I never heard how close he was, with roar of the crowd. My teammates yelled for me to lean. I won by 2 hundredths of a second. Never quit.
SVP und FDP legten zwar zu, doch die politische Mitte wurde bei den Gemeinderatswahlen geschwächt. https://www.nzz.ch/zuerich/lange-hofften-die-buergerlichen-am-sonntag-auf-die-grosse-wende-im-zuercher-stadtparlament-doch-am-ende-sollten-sie-scheitern-ld.1927965?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b87e
The way you're responding to this isn't novel or brave. Yuri Bezmenov already called you out all the way back in the 80s. You're being played.
"">@sasha_latypova is a pharma mole without ANY biological weapons knowledge and therefore NOT an expert witness. Just check her and other "witness'" CVs, none of them are experts in this field. It's frankly insulting to corona modRNA "vaccine" injured:
https://x.com/canceledmouse/status/2011537834591863277
Die neuen Bilateralen III ermöglichen der Schweiz ein «decision shaping» bei EU-Recht. Diese Mitsprache kann laut Praktikern durchaus nützlich sein – vorausgesetzt, man weiss sie richtig zu nutzen. https://www.nzz.ch/nzz-am-sonntag/report-und-debatte/schweiz-eu-was-bringt-das-neue-mitspracherecht-ld.1921457?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b87d
Our allies in Israel have shown amazing capability when it comes to collapsing the murderous regime in Iran. America is most appreciative.
However, there will be a day soon that the Iranian people will be in charge of their own fate, not the murderous ayatollah’s regime.
In that regard, please be cautious about what targets you select. Our goal is to liberate the Iranian people in a fashion that does not cripple their chance to start a new and better life when this regime collapses. The oil economy of Iran will be essential to that endeavor.
https://www.axios.com/2026/03/08/us-dismayed-israel-iran-fuel-strikes
Is this yet another attempt at whitewashing the SARS-COV2 virus and justifying their zoonotic theory? Kristian G. Anderson and mates in a new 2026 paper. Could someone please take away their typewriters.
@KevinMcCairnPhD @Jikkyleaks @Kevin_McKernan
https://www.cell.com/cell/fulltext/S0092-8674(26)00171-6?dgcid=raven_jbs_aip_email
Antisemitism destroys peoples cognitive capacity & judgement. It drives them to proudly support tyrants & terrorists & embrace fraudulent hate fuelled narratives.
Paris wählt eine neue Führung – und zum ersten Mal seit zwanzig Jahren könnte die Linke das Rathaus verlieren. Im 12. Arrondissement, zwischen Bastille und dem Bois de Vincennes, mischen sich die Wähler beider Lager. https://www.nzz.ch/international/das-12-arrondissement-ist-ein-wichtiger-swing-state-von-paris-wer-die-wahl-am-15-maerz-hier-gewinnt-koennte-auch-die-stadt-gewinnen-ld.1927620?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030969ab6a81e077e55d2a03b87c
Statt den Aufräumservice für Donald Trumps verantwortungslose Kriegspolitik zu spielen, sollte Europa deeskalieren, Verbündete am Golf finden und versuchen, auf den Machtwechsel in Teheran Einfluss zu nehmen. https://www.nzz.ch/nzz-am-sonntag/report-und-debatte/europas-ohnmacht-im-iran-konflikt-was-jetzt-zu-tun-ist-ld.1927516?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030869ab6a81e077e55d2a03b87b
The media bias and mayor's public statement on the Gracie Mansion story is a case study in misleading narrative formation.
1/4
Agent Qaani, we need you for one more mission
Thank you @EmmanuelMacron, for finally taking an active role in this war by explaining to Pezeshkian exactly how to surrender 🙏
BaWü:Die bisherigen Regierungsparteien sind mit über 60 ‼️ Prozent wiedergewählt worden.Eine Fortsetzung dieser erfolgreichen Zusammenarbeit ist von den Wählern gewünscht und war von beiden Parteien beabsichtigt. Das Wahlergebnis gibt Rückenwind.
🖤💚🖤💚🖤💚🖤💚🖤💚🖤💚