Most people wait for the press release. By then, the move is priced in.

Here's what actually happens before a major FDA approval — and how you can see it coming with nothing but publicly available data:

1. Advisory Committee voting patterns

The FDA doesn't make decisions in a vacuum. Advisory committee meetings are public. The voting records are public. When you track individual committee members' historical voting patterns on similar drug classes, you can model approval probability with surprising accuracy. Most people don't even know these meetings exist.

2. Clinical trial site expansion timing

ClinicalTrials.gov updates are real-time and free. When a Phase 3 trial suddenly adds 15 new sites in 3 countries within a 2-week window, that's not random. That's a company preparing for a commercialization timeline they haven't announced yet.

3. Patent filing clusters in foreign jurisdictions

This is the one nobody talks about. Before a US approval, companies file manufacturing and formulation patents in their target launch markets — EU, Japan, Brazil. These filings hit international patent databases weeks to months before any public announcement. The information is free. Nobody looks.

None of this is insider information. It's all sitting in public databases. The edge isn't access — it's knowing where to look and what patterns to watch.

This is what we do at OmniTyx. We run systematic OSINT pipelines across regulatory, clinical, and patent data to surface signals before they become headlines.

If that sounds like your kind of thing, you know where to find us.