The FDA and SEC maps
What the FDA Ephemeris, the SEC Ephemeris and the overview each chart, and how their options differ.
The Ephemeris is split into corpora: sets of records from one source. Each corpus has its own map; the overview shows them together.
The FDA Ephemeris#
Address: /ephemeris/fda/. Subtitle: “Every drug approval, charted as it is read. Now charting: Alzheimer's disease.”
The FDA map holds three kinds of items:
- Drug programmes
- A drug's FDA application and its documents: reviews, letters, labels and correspondence. Today these are the anti-amyloid antibodies Aduhelm, Leqembi, Kisunla and Leqembi Iqlik.
- FDA regulatory records
- Records that belong to no single drug, such as the Advisory committee record (committee meetings) and Federal Register notices.
- Listed drugs
- Approvals known from Drugs@FDA whose documents have not been fetched yet, for example Aricept or Namenda. They appear as small grey dots in a group captioned LISTED ONLY.
The list's last group, Cases in the record, lists the FDA decisions read from the documents, with how many of each decision's documents are in the graph.
The SEC Ephemeris#
Address: /ephemeris/sec/. Subtitle: “What companies told investors after an FDA Complete Response Letter, charted as it is read.”
Each item is a company that received an FDA Complete Response Letter (CRL). Its cluster holds the letter and what the company filed with the SEC around it:
- Complete Response Letters
- Current reports (8-K) and press releases (8-K exhibit 99)
- Annual reports (10-K)
Company rows and pages show SEC-specific facts: Ticker, Product, Response path (for example Response in progress, Resubmitted; CRL again or Formal dispute resolution), the dates of each Complete Response Letter, and Where it stands.
The overview#
Address: /ephemeris/. Legend entries are prefixed FDA: or SEC: so you can tell the corpora apart.
Options that differ by map#
| Option | Overview | FDA | SEC |
|---|---|---|---|
| Group by: Disease area, Application type, Sponsor, Document type, Graph status | Yes | Yes | Yes (Sponsor is called Company) |
| Group by: Drug class | Yes | Yes | Called Therapeutic area |
| Group by: First approved, Drugs@FDA status | No | Yes | No |
| Group by: Response path, Latest CRL, CRLs published | No | No | Yes |
| Cases in the record | Yes | Yes | No |
See Group the map for every option.