That’s a pretty good analogy. The Army of the Potomac had leadership that either was good at playing by the rules, but not winning battles( McClellan), or tooting their own horns ( Burnside, Hooker). Not unlike our Dem Congress critters.

Yes, insane, but Sinophobia is a thing right now. Can’t count on rationality.

And why should they be? Seems entirely on brand.

Well I guess it won’t matter that the payline is going to drop, because if this passes, a large proportion of American scientists will become ineligible, particularly if it is 5 years retroactive.

Can’t wait to see what Director Pazdur has in store. He is not loved at CBER. But he is a professional.

Grifters gotta stick together.

Happy vaginas make happy marriages? Sorry, very cynical about this. And yes, they will apply this what Makary says goes policy wherever they can get away with it. Throwing Pazdur into the mix should be interesting.

The unusual process seems to be becoming the usual process in labeling change. Data? Nahh. Something Makary wants to do? Yah. I am wondering what constituency or MAGA goal is advanced by this, though.

It is a promising treatment for an intractable disease. I am sure the reviewers at CBER want to see it progress. But every subpar treatment that gains approval can foreclose another behind it that is better. So this is very tricky.See Serepta.

Prasad is famous for the parachute trial( you don’t need a placebo when testing parachutes) ( which is silly, because that would be a noninferiority trial). But his actions have been otherwise, very conservative.

Seems the issue is the control. It is run against natural history, not placebo for ethical reasons. If the controls are poorly matched ( age, extent of disease) data is hard to interpret. So could be an actual scientific reason, or Prasad. Or both…