Estimated Time and Event Schedule for Fuzeon Filing and Launch
Q2 2002
Q3 2002
NDA Package Completion:
24 Week Data
Priority Review
Filing Update
Clinical
Fuzeon Approval/ Launch*
Manufacturing
Regulatory
Q4 2002
Q2 2003
Q1 2003
NDA –
Rolling Submission
Scale up of Drug Substance
Trial Runs
45 Day Review
*Assumes all issues addressed and FDA approval given this scenario
Additional Data Analysis
Validation Batches
NDA Submission Complete
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