The New Coffee Room

Ended up not taking it. We really had our hearts set on vandalizing the station but gave up when we realized we had to pay to enter. Also we rented a car.

Now it looks like Prasad was just sidelined on the decision (no doubt due to pressure described above), so the leaders of CBER that he had overruled just withdrew his letter in a meeting with Moderna and issued a new letter agreeing to review the original submission. So basically ex post ante. I suspect the White House itself was involved.

Optimistically a regime that didn’t pursue nuclear weapons for millenarian purposes, didn’t build proxy armies all over the Middle East (and soon Europe) to destabilize governments also for millenarian purposes, etc.

But we know better than to be too optimistic about these things.

said in Beyond the antivaxx stuff MAHA is either banal or fake:

@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.

The one exception to this, sort of, is late adolescent males and the Covid vaccine. I say ‘sort of’ because it took a while for the data to come in so some delay is to be expected, also how the benefit-risk shakes out is highly dependent on things like severity of the current wave, brand of vaccine, dosing interval, etc. Still, when there was a reasonable amount of data available to show it was borderline or worse there were still public health officials who were afraid to address it lest they fuel vaccine hesitancy more broadly. A friend of mine was a lonely but ultimately effective voice in preventing a major university from requiring Covid vaccines in incoming freshman for this very reason.

@klaus Right but those are pretty accurately accessed by public heath professionals which is why you don’t see yellow fever vaccines in the recommended panel.

I would caution you against assuming there’s even an ounce of rationality behind the anti-vax movement. It’s one part naturalistic fallacy, two parts resentment, and three parts conspiratorial thinking.

@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:

Anyway, the official story is that Moderna made changes to their application, and the FDA accepted the revised version. Everything else is narrative. But the implication that the FDA simply reversed is not accurate. Moderna did make changes to the app. According to my exhaustive google search.

As I said they likely promised a post marketing study. FDA last week said they would not review the submission because they (really he) didn’t accept the previously agreed upon study design. Now FDA says they will review the submission based on the previously agreed upon study design.

If that’s a non-back track, I would welcome more non-back tracks on vaccine policy in the future.

@Horace said in Beyond the antivaxx stuff MAHA is either banal or fake:

You seem confident that the FDA can reverse a written decision on the spot, but are unable to expedite a meeting on the spot.

Meetings take a lot of preparation, presentations, data, etc. Writing a letter agreeing to review a submission in the future is trivial and was clearly done regardless of what else happened.

said in Beyond the antivaxx stuff MAHA is either banal or fake:

Far more lijkely is Senators applied pressure ...

And administration friendly investors. (A16Z has a biotech fund after all). What was particularly insidious about this decision was indication that the FDA couldn’t be trusted to keep to its own written word. How are you supposed to invest hundreds of millions into a p3 trial when the FDA backtracks on its own written approval of the design after the funds have been spent?

Zero chance they had a their type A meeting in the time since this unfolded. Far more lijkely is Senators applied pressure (ie, the system worked) and FDA got some face saving vague promise for a post marketing study.

I remember a poignant scene of him with a tear running down his face at a rally in Chicago celebrating Obama’s inauguration. They may have had their issues interpersonally or politically, but seeing the first black president be inaugurated clearly had an impact on him.

Hmmm.

Prasad walked it back.

Wow.

Best comment: Even the guitar blushed and asked him for his number afterwards.

Our school trustees are smarter but none have that rack.

You know how, when you work out for the first time in a while, your muscles are sore not one but two days later? My lower legs had these strange sore spots in muscles I never use that had been cramped up the other night. It still lingered a bit this morning.

RIP.

I remember running into him at O’Hare in 91 or so. Asked his if he’d be running again, he just winked.

Sounds like Trump had some nice words to say about him, though I haven’t seen the whole quote.