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.
well the first thing you have to do is um file for something called an ind an investigational new drug application so after you do all of this pre-clinical work you have to file this ind with the fda and that basically sets your intention of testing this as a drug in humans and the first phase of that which is called phase one is geared specifically to dose escalate this drug from a very very low level to determine what
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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.
the first phase of that which is called phase one is geared specifically to dose escalate this
phase one is has one purpose phase one is is it safe to give humans this molecule is it safe to give it once is it safe to give it multiple times
with a good preclinical package a good IND phase one should be uneventful