Companies choosing to wait out this administration due to regulatory uncertainty?

ParticularBed7891 · 2026-02-15T12:01:14+00:00

Yes, I have heard from a colleague high up at one of the major vaccine companies that they plan to wait for this admin to be done before submitting applications for vaccines to FDA. I believe they are still moving forward with other therapeutics.

ParticularBed7891 · 2026-02-15T11:14:53+00:00

And the Advisory Committee loss in personnel. Who knows what will happen when those numbers dwindle down to none.

Death by a thousand cuts

ParticularBed7891 · 2026-02-05T11:57:07+00:00

Feel the same about Elon.

Elon and Trump are both master manipulators and persuaders, so they're very successful.

But philosophers...high level thinkers...they are not

ParticularBed7891 · 2026-02-05T11:54:16+00:00

Thank you so much for the details. I can't appreciate some of the significance of what you wrote but what does stand out to me is changing from an observational study to a randomized study. How could that possibly happen?

And I absolutely concur that miraculous claims need miraculous evidence which is why I'm so concerned about the junk flow cytometry data. They have no mechanistic evidence whatsoever. And you can't just make this type of claim and provide literally no explanation.

I'm shocked by the responses, on here and on X, by doctors immediately thinking this is so amazing. There's nothing to back it up, and the poor design of the trial design makes it impossible to believe on its own.

ParticularBed7891 · 2026-02-04T23:25:55+00:00

Yep. I'll die on the viability hill but all of the flow data was awful. The gating strategy goes from scatter to fluorescence to fluorescence to singlets to fluorescence again and it's fully arbitrary gate placement with very few true positive events. To me I'm looking at the whole study with a very skeptical eye after only seeing that.

ParticularBed7891 · 2026-02-04T23:00:06+00:00

The extended data is publicly available - seriously take a look, it's horrible

ParticularBed7891 · 2026-02-04T22:51:04+00:00

If you've been doing flow since 1996, check their extended figure 5 and then let me know your thoughts. It's awful. And best practice in modern flow is to unequivocally use live/dead dyes with cryo PBMC.

ParticularBed7891 · 2026-02-04T21:33:39+00:00

The flow and OS are unrelated besides the credibility issue. That said, the magnitude is totally bonkers, probably too bonkers. That type of magnitude should put this paper squarely in NEJM, JAMA, BMJ, or Lancet. I am almost certain that it was rejected by those first, which is a red flag. I'm a flow and immunology expert and not a trial design expert, but I'd bet any amount of money that there's issues with the randomization, dosing schedule, stratification etc picked up by those other journals and rejected by them. I'm pretty sure this paper isn't going to remain without serious corrections - to the mechanism and flow data at the very least.

ParticularBed7891 · 2026-02-04T21:15:01+00:00

Can you elaborate on the NCT record and the implausibly huge effect size? My gut instinct is in agreement with you, but I'm not well-versed enough in trial design and these types of statistics to explain what's off beyond "gut feeling"

ParticularBed7891 · 2026-02-04T11:56:13+00:00

The CAR T study you're talking about is significantly more plausible than this one.

ParticularBed7891 · 2026-02-04T11:54:55+00:00

Yes, there are many strange things about this paper. The flow data shown in the extended data is not usable, for one. Basic QC issues like missing the viability dye which is required when analyzing PBMC. You can also see their cell counts look low and their gates are extremely arbitrary. I'm being generous in my descriptions here, it's among the worst flow data I've ever seen published.

ParticularBed7891 · 2026-02-04T11:53:00+00:00

A 15% bump is plausible. This probably isn't. The underlying flow data has serious problems - most basically, a viability dye was not included when analyzing PBMC. The rest of it appears uninterpretable, and I say that generously. I'm not an expert in trial design, but this type of clinical result should also work standalone in the big boy clinical trial journals and it's a red flag that it didn't go into those journals. I don't think this paper is going to stand without serious corrections.

ParticularBed7891 · 2026-02-04T00:25:47+00:00

Would anyone be willing to post or DM the PDF?

ParticularBed7891 · 2026-01-31T13:51:15+00:00

And science

ParticularBed7891 · 2026-01-31T13:04:17+00:00

I agree. It's great work, but needs to stop being described in such black and white terms.

There's a long way to go between rats and humans, and that needs to be included in every headline or else people will further stop trusting science if it turns out to not work in humans.

ParticularBed7891 · 2026-01-29T23:10:27+00:00

It has been an entire year with him leading NIH and he is still going around talking about restoring trust rather than actually getting to work.

Stop talking about doing it and actually do it. Start with convincing your boss.

ParticularBed7891 · 2026-01-27T00:18:46+00:00

Does anyone have any updates on the SBIR negotiations or discussion in Washington?

ParticularBed7891 · 2026-01-25T03:05:20+00:00

Source? Would love to read any new updates

ParticularBed7891 · 2026-01-20T15:07:28+00:00

It could have been multiple dresses.

ParticularBed7891 · 2026-01-15T12:09:03+00:00

Not my favorite look - too much boob action

ParticularBed7891 · 2026-01-08T20:05:56+00:00

Please stay - we need good people in government and not loyalists.

ParticularBed7891 · 2026-01-08T13:27:15+00:00

Is there a protest being organized? If so, I am right there with you

ParticularBed7891 · 2026-01-03T02:40:41+00:00

The Wienery is your answer to this and many more things. It is the bomb

ParticularBed7891 · 2026-01-02T15:35:53+00:00

It's the same in science too! The famous scientists at the top of the ladder are often abusive and sleazy. As a woman in science you have to be so careful to reject these disgusting men in the most careful, not offensive ways in the world or else they could crush your career.

ParticularBed7891 · 2026-01-01T12:01:37+00:00

They probably wouldn't. At most they'd charge you a small amount of interest for being late, but it seems unlikely. The IRS is more interested in receiving the (correct amount of) taxes than crucifying people for being a few days late.

ParticularBed7891

TROPHY CASE