BrainStorm Cell Therapeutics Inc (BCLI)

[bubbarayjr]

Will be interesting to see how the committee interprets this but there's a BIG difference between AMLX and BCLI. AMLX needs to convince the FDA that their new model to evaluate efficacy is solid even though their clinical trial was not designed for it and there's not historical data to support doing so.

BCLI's issue is much different. The vendor in charge of analytical analysis of the trial data made a mistake. Correcting this error resulted in A STATISTICALLY SIGNIFICANT outcome in a KEY SECONDARY ENDPOINT which WAS PRE-SPECIFIED in the trial study designed (no smoke and mirrors). AND many of the BIOMARKERS the FDA believes are important to measure disease showed SIGNIFICANT improvement.

Definitely not Apples to Apples, more like Apples to Dollar bills IMO