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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