Updated timelines for pilot 3 resubmission (#111)

pilot3.qmd

@@ -4,61 +4,64 @@ title: "R Submission Pilot 3"
 
 **Goals**:
 
-- Expand on the work done in [Submission Pilot 1](pilot1.qmd), by now utilizing R to generate ADaM datasets.
-- Deliver a publicly accessible R-based Submission to the FDA
+-  Expand on the work done in [Submission Pilot 1](pilot1.qmd), by now utilizing R to generate ADaM datasets.
+-  Deliver a publicly accessible R-based Submission to the FDA
 
+**Key evaluation aspects**:
 
-**Key evaluation aspects**: 
-
-- For Submitter 
- - Generation of a reproducible R environment with a proprietary R package from git and open source R packages using `{renv}`
- - Preparation of R-based submission materials
-- For FDA Staff
- - Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages
+- For Submitter
+ - Generation of a reproducible R environment with a proprietary R package from git and open source R packages using `{renv}`
+ - Preparation of R-based submission materials
+- For FDA Staff
+ - Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages
 
-**Timeline**: Submitted to FDA on August 28th, 2023
+**Timeline**:
+
+- Submitted to FDA on August 28th, 2023
+- Feedback from FDA on February 2nd, 2024 (See feedback [here](https://rconsortium.github.io/submissions-wg/minutes/2024-02-02/))
+- Re-submitted to FDA on April 19th, 2024
 
 **Data and analysis scope**:
- 
-- ADaMs created using R (SDTM `.xpt` sourced from the CDISC Pilot study)
-- TLFs created using R (ADaMs `.xpt` sourced from the ADaMs generated in R by the Pilot 3 team)
+
+-  ADaMs created using R (SDTM `.xpt` sourced from the CDISC Pilot study)
+-  TLFs created using R (ADaMs `.xpt` sourced from the ADaMs generated in R by the Pilot 3 team)
 
 **Links**:
 
 [R Submission Pilot 3 Development Repo](https://github.com/RConsortium/submissions-pilot3-adam)
 
-- Development area for Pilot 3 Team
-- See Closed Issues discussion for how we worked
-- See [Wiki](https://github.com/RConsortium/submissions-pilot3-adam/wiki) for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.
-- We made use of a [GitHub Project Board](https://docs.github.com/en/issues/planning-and-tracking-with-projects/learning-about-projects/about-projects) (Kanban Style Board) to drive development. 
+-  Development area for Pilot 3 Team
+-  See Closed Issues discussion for how we worked
+-  See [Wiki](https://github.com/RConsortium/submissions-pilot3-adam/wiki) for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.
+-  We made use of a [GitHub Project Board](https://docs.github.com/en/issues/planning-and-tracking-with-projects/learning-about-projects/about-projects) (Kanban Style Board) to drive development.
 
 [R Submission Pilot 3 eCTD Submission Package to FDA](https://github.com/RConsortium/submissions-pilot3-adam-to-fda)
 
-- Materials submitted to the FDA following eCTD standards
+-  Materials submitted to the FDA following eCTD standards
 
 [R Submission Pilot 3 Website](https://rconsortium.github.io/submissions-pilot3-adam/main/)
 
-- Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package
-- Renderings of ADaMs, TLFs, ADRG and Cover Letter
-- Discussions at Conferences and feedback from FDA
+-  Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package
+-  Renderings of ADaMs, TLFs, ADRG and Cover Letter
+-  Discussions at Conferences and feedback from FDA
 
-**Key team members**: 
+**Key team members**:
 
 Developer team:
 
-- Joel Laxamana-Roche
-- Thomas Neitmann-Denali
-- Phanikumar Tata-Syneos
-- Robert Devine-J&J
-- Steven Haesendonckx-J&J
-- Lei Zhao-Roche
-- Nicole Jones-Denali 
-- Kangjie Zhang-Bayer
-- Benjamin Straub-GSK
-- Declan Hodges-GSK
-- Bingjun Wang - Merck
-
-FDA Staff: 
-
-- Paul Schuette 
-- Hye Soo Cho 
+-  Joel Laxamana-Roche
+-  Thomas Neitmann-Denali
+-  Phanikumar Tata-Syneos
+-  Robert Devine-J&J
+-  Steven Haesendonckx-J&J
+-  Lei Zhao-Roche
+-  Nicole Jones-Denali
+-  Kangjie Zhang-Bayer
+-  Benjamin Straub-GSK
+-  Declan Hodges-GSK
+-  Bingjun Wang - Merck
+
+FDA Staff:
+
+-  Paul Schuette\
+-  Hye Soo Cho