Forecast Ledgerinterventional psychiatry and psychedelic medicineQuoted, dated predictions scored against public outcomes under one written method. Every score links to the words, the rule and the evidence.

Not admitted · Outcome already public

Rules 1.1.0 · as of 14 Sep 2026

Quote

Outcome already public

“The label—also not yet available on the FDA website—must say this is an adjunctive approval: The device is intended for use alongside – not as a replacement for – a clinician-directed treatment plan.”
· A New At-Home PTSD Treatment is FDA-Approved! · substack post

Neurovalens Modius Spero vestibular nerve stimulator (VeNS), FDA De Novo grant for PTSD announced the day before. The FDA label was not yet posted; the author infers from company language that the label will state an adjunctive indication alongside a clinician-directed treatment plan.

The outcome had been publicly determined or announced by the deciding body or sponsor on the statement date.