PDUFA date changes: how to preserve the evidence

Two exact date revisions reported by the sponsors

Both earlier and revised targets are explicitly stated in the linked primary document. These retrospective records do not imply this pilot was monitoring the application when the earlier date was assigned.

Changes documented in this selected cohort

The source notes below explain application scope and disclosed revisions. They are context notes, not a complete event-by-event history.

A revision is a new observation

Savara describes a three-month extension in its quarterly filing; Praxis describes an updated relutrigine review target in its disclosures. These are reasons to retain the date history. They do not justify estimating an earlier exact date from arithmetic.

Record an old target only if a dated primary source explicitly states it. For a new date, add the announcement date, old source, new source and the sponsor’s stated reason. Preserve uncertainty when the reason is not given.

After the goal date

Do not infer a decision from the passage of time. Check current sponsor announcements, any SEC-filed release, and FDA material. If no action can be confirmed, label the row “goal date passed — outcome needs review” and retain the last supported target.

When a decision is confirmed, record the action and its own source separately from the historical goal date. That makes later timing analysis possible without erasing the original expectation.