The PDUFA date is the target action date for the FDA to make a decision about a NDA. The PDUFA date is sometimes referred by investors as the "FDA Approval date". The FDA may approve the product or issue a CRL if they choose not to approve. Biotech stock investing is a high risk investment, especially on the small cap companies. I only list the PDUFA dates and Phase 3 clinical trial data releases dates due to shortage of manpower.