What is an FDA Advisory Committee meeting?
An AdCom is a public meeting where outside experts review a drug application and vote on whether the FDA should approve it. The vote is non-binding but heavily influential.
Learn
Plain-language explanations of the regulatory and clinical concepts that drive biotech catalysts. New entries added as we cover new topics.
What is a Complete Response Letter (CRL)?
A CRL is the FDA telling a drug sponsor "not yet, here is what we need." It is not an outright rejection but it means no approval on this cycle — and the stock pays.
What is a Phase 3 readout?
A Phase 3 readout is when a sponsor releases topline efficacy and safety data from the pivotal trial that will determine whether the drug gets approved. For single-asset biotechs, this is often the biggest stock-move event of the year.
Hatch-Waxman and Paragraph IV explained
The Hatch-Waxman Act is the framework that determines when generic versions of a brand drug can launch — and Paragraph IV is the legal challenge that triggers a 30-month stay or a generic launch.
Cash runway in biotech, explained
Most clinical-stage biotechs burn millions per quarter with no revenue. Cash runway is the most important number on a biotech balance sheet — the date by which the company must raise money or run out.
What is a PDUFA date?
PDUFA dates are deadlines the FDA commits to when reviewing a drug application. They are the single most-watched catalyst in biotech.