De­spite red flag from FDA, con­tro­ver­sial ALS cell ther­a­py de­vel­op­er says it may still march ahead any­way

When Brain­Storm Cell Ther­a­peu­tics broke out the abysmal num­bers in its Phase III tri­al, the biotech in­sist­ed that the FDA was ea­ger to re­view the da­ta — giv­en the sig­nal they had iden­ti­fied in a sub­group of amy­otroph­ic lat­er­al scle­ro­sis with less ad­vanced dis­ease.

Three months lat­er, reg­u­la­tors did give a look to the high-lev­el sum­ma­ry of the da­ta. But they didn’t have too many good things to say.

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