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pilot3
3.3.3
Project Background/Setup
Project Background
Project Setup
Statistical Software Clarifying Statement
Deliverables
Cover Letter
Displays
Summary of Demographic and Baseline Characteristics
Efficacy Tables
Kaplan-Meier Plot for Time to First Dermatologic Event
ADAS Cog Change from Baseline to Week 24 - LOCF
Datasets and ADRG
ADSL - Subject Level Analysis
ADAE - Adverse Event Analysis
ADLBC - Laboratory Results Chemistry Analysis
ADTTE - AE Time to 1st Derm. Event Analysis
ADADAS - ADS-COG Analysis
ADRG - Analysis Data Reviewers Guide
Conferences
PHUSE SDE London
PHARMA SUG Baltimore
WG Minutes and Regulatory Feedback
R Consortium WG Meeting Minutes
August 2024
June 2024
May 2024
April 2024
March 2024
February 2024
January 2024
December 2023
November 2023
October 2023
Pilot 3 Submission Issues Compilation
January 2024 FDA Feedback Summary
Pilot 3 Successfully Reviewed by FDA CDER
FDA Response Letter
Pilot 3 Successfully Reviewed by FDA
Cover Letter
cover-letter.Rmd
Cover Letter