How we source and check catalyst dates

Where the dates come from

• FDA decisions (PDUFA dates): the company’s press releases and the 8-K, 6-K and 10-Q filings it makes with the SEC (searched on EDGAR twice a day), and FDA announcements.
• Advisory committee meetings (AdCom): the FDA’s meeting notices in the Federal Register and company announcements.
• Clinical trial readouts: ClinicalTrials.gov (primary completion dates, re-checked daily against the trial record) and company guidance. These are windows, so they are labeled estimated.
• Earnings, offerings, acquisitions: SEC filings and company announcements.

How an FDA decision date is checked

• A date is attached to a drug only when the filing names that drug in the same sentence as the date.
• A date checked against the company’s announcement is never moved by a news article or a model.
• When a later filing states a different date, the calendar follows the filing and the change is logged.
• A decision (approval, complete response letter, extension) is recorded from the company’s or the FDA’s announcement, with the stock move, on its outcome page.

What the labels mean

Confirmed: the exact day was checked against an official source. Estimated: a window (a month or a quarter) from ClinicalTrials.gov or company guidance; the day is not known. AI-detected: extracted from a news article and not yet tied to an official source.

Limits

The FDA can decide before or after its target date. Estimated dates are windows, not commitments. Private companies and non-US regulators are covered less completely. CatalystAlert is a research tool, not financial advice: confirm a date against its source before acting. The models behind the AI research are scored in public on the track record, including where they do worse than a naive baseline.