Next idea for BrainStorm is another Phase III trial in ALS
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) has opted to withdraw its submission.
The company was told before submitting that the efficacy data were not sufficient, but it decided to go ahead anyway, making a case based on its interpretation of the Phase III trial results.
Now BrainStorm has been invited by the US Food and Drug Administration to request an “expedited face-to-face meeting to discuss the path forward,” the firm said.
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