I understand how ambitious you want to make this study RSU successful and we want to achieve the same thing too.
how soon you can get all documents translated? That is late limiting steps for EC submission
- Did you send country ICF out for translation, when it plan to complete.
- When site ICF could be ready for Phusadee for reviewed as well other document that need to be translated.
I want to correct your number below, SIV target for Thailand this year is 261 days but that would be fortunate case, normally it takes about 90 days from EC submission to EC approval. IL approval, we have little influence once it is submitted.