BCLI - In unusual step FDA provides additional details on BrainStorm's NurOwn program

The FDA yesterday took the unusual step of issuing an update with further details on last month's feedback that a high-level data summary of BrainStorm Cell Therapeutics' (BCLI) NurOwn program for ALS did not provide substantial evidence to support a BLA application.The agency said it was issuing the update because of the "tremendous public interest in this product."The FDA said that none of the primary and secondary endpoints were met in the treatment arm.For the primary endpoint, 27.7% of people in the placebo group responded compared to 32.6% of people given NurOwn -- the 4.9% difference was not statistically significant.The FDA also said there was a "modest excess of deaths" in the NurOwn arm, though the significance of those death is unclear at this point.BrainStorm shares are down 1.5% to $3.93 in afternoon trading.

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In unusual step, FDA provides additional details on BrainStorm's NurOwn program