Avid Bioservices Inc (CDMO)

[freethemice]

Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
May 2007
Clinical/Medical
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf

In the following discussion, the term regular approval denotes the longstanding route of drug
approval based on the demonstration of clinical benefit. That term is distinguished from accelerated
approval, which is associated with use of a surrogate endpoint that is reasonably likely to predict benefit.

My take on this: If the second-line NSCLC trial results in statistically significant increase in MOS,
and hence clinical benefit, then they could apply for regular approval. If the MOS is very strong, but not quite
statistically significant, then they could apply for accelerated approval.