I am not an expert but I have two guesses on this debate.
1) All the literature says that they are determining the dosage on large animals. After that,it says there will be another "pivotal trial" that will lead to fast commercial marketization. Maybe the final trial is a fast track that evaluates safety?
OR
2) If they are treating ARS, the safety concerns may take a back seat to the fact that a population will have a high death rate either way. Safety wouldn't matter if a person is probably dead anyway. I'd guess there is an exemption based on compassionate use.
It's important to remember the application of R18! We're talking about individuals, who face a very high probability of death (after exposure to radiation), and subjective reactions, such as blurred vision will not be decisive.
I'm sure they did do a massive number of tests to see if any significant biological indicators were negatively effected, and they say, no, things are looking good.
My feeling is that due to the issues with N.Korea, the threat of terrorists with dirty bombs, and the possibility of industrial accidents, it would be the height of irresponsibility NOT to have a good supply of R18 stashed away and ready to be used. Waiting till 2019 to start building up a supply of R-18 and at the same time giving Pluristam the means to scale up their production capabilities cannot wait (at least if I was in charge!).
Safety studies can continue even as the responsible agencies acquire a supply of the stuff, just in case...!
That would be my argument for pps relevant news much earlier than 2019.