I read the article in Hebrew without Google translate.
Regarding FDA approval, the sentence is: "We shall get approval early 2018 after the latest trial".
Any claim that the trial is over is highly speculative.
The article mentions that the assembly line for manufacturing VB-111 is still being put together. Their plan calls for the manufacturing plant to get FDA approval within 18 months.
I also learned that Nano Carrier is a bio-tech company in its own right. They will be responsible for getting the required approvals from the local authorities for the Japanese market.