The headline is broadly defensible, but the qualifications matter. Effect sizes vary by population, the strongest claims rest on shorter trials, and credible voices push back on how it's typically framed.
and the the critical thing is the preclinical work that you do what FDA is going to want to ask you and they should this is not them being bad this is them being good they're going to want to ask you about toxicology what's your safety plan based on biology of edge off what are you most worried about i'm most worried about bleeding it's an antibbody i'm most worried about an allergy to the antibbody
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Native comments, Twitter mentions, and Reddit threads about this claim — surfaced together so the conversation isn't fragmented across platforms.
Bookmarking — the dossier-vs-overview split is the right call. Most of the time I want overview; sometimes I want receipts.
Would love a "what would change this verdict" RSS feed. Sign me up if it exists.
And then the the critical thing is the preclinical work that you do. What FDA is going to want to ask you, and they should, this is not them being bad, this is them being good. They're going to want to ask you about toxicology. What's your safety plan based on biology of Vegoff? What are you most worried about? I'm most worried about bleeding. It's an antibbody. I'm most worried about an allergy to the antibbody. Did any of the p the uh um talk studies show allergy to the antibbody? What are you going to look for? And how are you going to look? How often are you going to measure the patient? So the pre-clinical safety plan is really important and based on what you find in toxicology.