Brain­Storm out­lines plans for what may be fi­nal at­tempt to bring ALS drug to mar­ket

Hav­ing ex­haust­ed near­ly all oth­er av­enues to get its ALS cell ther­a­py ap­proved, Brain­Storm Cell Ther­a­peu­tics is heav­ing a Hail Mary pass.

The biotech an­nounced Tues­day that it is mov­ing for­ward with a Phase 3b study for the treat­ment, called NurOwn, and that it has agreed to a Spe­cial Pro­to­col As­sess­ment, or SPA, with the FDA. Brain­Storm said the study is ex­pect­ed to launch some­time this year, but didn’t pro­vide any more specifics in a press re­lease or dur­ing an in­vestor call Tues­day morn­ing.

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