FDA rais­es con­cerns over TG Ther­a­peu­tic­s' sur­vival da­ta, plans to con­vene ODAC

TG Ther­a­peu­tics took a hit Tues­day morn­ing af­ter an­nounc­ing the FDA will con­vene an ad­comm ahead of the biotech’s up­com­ing PDU­FA date for a blood can­cer com­bo ther­a­py, throw­ing a po­ten­tial de­ci­sion in­to lim­bo.

Though the ex­act date has not been de­ter­mined, reg­u­la­tors are look­ing to hold a meet­ing of the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee some­time in March or April, TG said in a re­lease. Giv­en that tim­ing, the biotech says it’s now un­like­ly the FDA will reach an ap­proval de­ci­sion by the March 25 dead­line.

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