TG Therapeutics maps a shortcut to the FDA with lead drug for CLL
TG Therapeutics $TGTX will take a shot at shortening the Phase III runway for its lead effort on ublituximab (TG-1101).
The biotech, which has been grappling with enrollment issues, says it plans to lop off the second stage of what was once a two-step development approach, dropping a look at progression-free survival with the FDA’s blessing and hustling overall response rate data to regulators if it bags positive results in the first half of 2017.
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