There are 2 ways to read that...either they show be completing the studies now to get approval by 4Q2019, or they are completing all that is necessary to initiate those trials by 4Q2019. I guess we would need further clarification from Joe or GNBT.
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Disclaimer: Of course, all of this is my opinion and you should not make any investment decisions based on my opinion. I have not received any non-public information.