Regulatory questions (threads)
Follow five recurring regulatory questions across every anti-amyloid decision, and see where the FDA held or moved its position.
The threads page, /threads/ (header link Questions), answers one question: where did the agency hold, and where did it move? It follows five regulatory questions that recur across every anti-amyloid decision.
The five threads#
| Thread | Question |
|---|---|
| T1 Surrogate | Is removing amyloid reasonably likely to predict benefit? |
| T2 Effect size | Is the difference on the cognitive scale meaningful? |
| T3 ARIA | How is swelling and bleeding risk weighed, monitored and labeled, including for ApoE4 carriers? |
| T4 Data | Were the trials, analyses and exposure adequate? |
| T5 Confirmatory | What did approval require next, and was it delivered? |
The grid#
Threads run down the side and decisions across the top, in date order. Each cell shows one pill per distinct status the agency took on that thread in that decision, and +n when there are more positions. A dash means no position is recorded (hover it to see whether the record is incomplete). On narrow screens the grid scrolls sideways.
Read a row from left to right to see one question's history. For example, a row that starts with Origin and continues with Consistent means the agency kept to its first position.
Follow one thread#
- Select a thread in the thread list (for example T3 ARIA). The page shows only that thread.
- Read the chain of positions in date order. Each step shows the position ID, its decision, a status pill, the quote, the citation and the relation line: “Compared to <id>, <decision>, <date>.” The first step reads “Origin: the first agency position on … in this record.”
- Select a decision to open its entry, or the citation to open the FDA page.
The address changes to include the thread, for example /threads/#T3, so you can link to it.
Gaps are shown, not hidden: [no position recorded on this thread] or [record incomplete: no position loaded].
Status meanings#
See Status reference.