Acambis Initiates Rolling BLA For Its Cell Culture-Based Smallpox Vaccine
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm said it expects to complete the filing by April and receive approval by year-end.
You may also be interested in...
Acambis’ Smallpox Vaccine Could See Approval As Soon As First Half 2007
An FDA “complete response” letter for the cell-based vaccine cites both clinical and CMC sections of the BLA, firm tells “The Pink Sheet” DAILY.
Acambis’ Smallpox Vaccine Could See Approval As Soon As First Half 2007
An FDA “complete response” letter for the cell-based vaccine cites both clinical and CMC sections of the BLA, firm tells “The Pink Sheet” DAILY.
Acambis Completes Smallpox Vaccine BLA
Acambis' ACAM2000 would have a mid-October estimated user fee date if the BLA is granted a priority review