Black box warning

Um, I know I'm-- So my next live webinar's gonna be on the vibrator, then I'll probably do another testosterone one because you guys are hungry for, uh, testosterone help.

What else do I have? This is me helping to remove the boxed warning.

Thank you to everybody who helped.

That, that was over a decade in the making.

All the haters are like, "They just decided on a Tuesday." I'm like, "No, they didn't." We-- They were working for over a decade to get the boxed warning off of this.

Um, so boxed warning's off because vaginal estrogen does not cause blood clots, stroke, cancer, all the things.

So that was a very, very fun.

Um, and then I just wanted to end with this person.

A disease that has gone decades with nothing but steroids just got its first targeted pill, and the FDA stapled a boxed warning to it.

Plus, Spire is deprioritizing its rheumatoid arthritis drug after yesterday's miss.

Tezspire cleared phase three in eosinophilic esophagitis, and Seastone put up lung cancer numbers that need a second read.

Roivant and Priovant announced it today, and it's prescribable in the US as of this afternoon.

But the number that decides this launch isn't an efficacy number.

It's the boxed warning, serious infections, mortality, malignancy, MACE, thrombosis, the full JAK class label in a disease where the incumbent treatment is chronic high-dose prednisone.

Then say the comparator out loud because that framing cuts the other way.

Fifty-five percent of patients on Lizria hit the composite of moderate or better improvement on the total improvement score, plus minimal or no steroid use at fifty-two weeks against thirty percent on placebo.