pdufa.bio
Home › Why we don't show an approval %

Why we will never show a fake approval probability

Updated ยทnext FDA decision on the calendar

Several catalyst sites now print an “AI” approval percentage on every drug, 82%, 99%, a tidy number that feels like insight. We refuse to. Not because we can't generate one, but because a single per-drug percentage is, for a binary regulatory event, false precision that misleads.

The failure mode that breaks the number: a drug can have two clean, statistically significant Phase 3 trials and still get a Complete Response Letter; for a manufacturing (CMC) problem, a third-party facility inspection, or a labeling dispute that has nothing to do with whether the drug works. A “99% approval” tile cannot see that. The history is full of strong-data drugs that were delayed or rejected on issues no efficacy model captures.

So instead of inventing a probability, we show you the things that are actually true and verifiable:

The verified facts, the FDA-set or company-guided date, the drug, the indication, each tagged by how we know it and linked to a primary FDA, SEC, or ClinicalTrials.gov source.
Historical base rates: how this kind of decision has resolved (by therapeutic area, by cap size, after a prior CRL), with the sample size shown, not a confident point estimate dressed up as one.
The run-up path; what the market is actually pricing into the date, not what we guess the FDA will do.
Our own misses, we label price-only data, flag unverified items, and post corrections. A black box can't do that.

A fake 82% asks you to trust a model you can't inspect. Verified history and sourced facts ask you to think for yourself, and give you what you need to. That is the entire difference, and it is the one thing none of the “AI %” sites can copy without rebuilding their pipeline around the truth.

Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.

Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.

© 2026 pdufa.bio. All rights reserved.