NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Connecting the dots . . . this might explain the double shifts at Sawston.

Week 6-9: Under the RTOR program, the applicant would officially submit the following items to their marketing application as a pre-submission  as soon as they become available:
1. User fee, if applicable
2. Complete SDTM dataset package
3. Top line efficacy/safety tables/figures
4. Complete ADaM datasets for key efficacy and safety tables/figures for pivotal study (see OOD data specifications for requested format of safety datasets)
5. Key results, analysis, and datasets for other disciplines, if applicable.
6. Final study reports of all pharmacology and toxicology studies
7. Summary of data supporting dose and dosing regimen selection
8. The protocol and amendments (a list of major changes for each amendment), SAP, and DMC charter and DMC minutes
9. SAS programs
10. Proposed labeling
11. CRFs as required by regulation
12. All CMC information including list of all manufacturing, testing and critical intermediate facilities with addresses and FEI numbers other than stability data for registration batches (if not available) for drug substance(s), drug product.
13. Completed AAid.