As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A lit­tle more than a week af­ter Brain­Storm ac­knowl­edged that reg­u­la­tors at the FDA had in­formed them that the biotech need­ed more da­ta be­fore it could ex­pect to gain an ap­proval for its ALS treat­ment NurOwn — while still tout­ing a “clear sig­nal” of ef­fi­ca­cy and not rul­ing out an ap­pli­ca­tion — the agency has de­cid­ed to clar­i­fy the record in a most un­usu­al state­ment.

The FDA state­ment amounts to a straight slap­down, of­fer­ing a dif­fer­ent set of ef­fi­ca­cy num­bers from the com­pa­ny’s pub­lic pre­sen­ta­tion last No­vem­ber and rul­ing out any chance of sta­tis­ti­cal sig­nif­i­cance.

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