- It is sRSU responsibility to customize site ICF. Do you have cRSU for this study?
- All documents I mean, other patient facing documents, advertisement. Do you have such documents?
- So can you be sure that country, all site ICFs and country ICF can be available on 24 Jun? it is just less than 2 weeks togo.
- After we have all documents translated, we need about 2 weeks for customize them into site and local forms.
- You can run ‘interim Cycle Time’ to check what is 2014 median SIVs Timeframe.
Phusadee, can you check with EC websites how much initial submission fee and request for approval Diego and raise PR according.