Officially FDA has up to 60 days with BTD I believ
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But knowing the disease and Leronlimab , I will hope they will answer much sooner..
And BTD is not an approval.
IMO few months later approval, but FDA can stop all study at any time and approve.
So no one cant predict exactly , but very possibly 1H of 2020 approval , or at least 2020.
IMO of course.