Brain­Storm gets FDA ad­comm for ALS drug af­ter failed tri­al and RTF

Brain­Storm Cell Ther­a­peu­tics has had a rocky road try­ing to get its ALS treat­ment through to the FDA, in­clud­ing a par­tic­u­lar­ly dif­fi­cult set­back af­ter the FDA slapped the com­pa­ny with a re­fusal to file (RTF) let­ter in No­vem­ber af­ter it sub­mit­ted its orig­i­nal BLA in Sep­tem­ber last year.

But there’s a glim­mer of hope for Brain­Storm’s ALS treat­ment, NurOwn – the FDA will hold an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss the com­pa­ny’s BLA for the treat­ment, the com­pa­ny an­nounced to­day.

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