BrainStorm Cell Therapeutics Inc (BCLI)

[bubbarayjr]

My guess is the BLA was filed around the first of September. If I'm correct we'll hear from the FDA by the end of October. FDA acceptance and Priority Review are a slam dunk. It would be surprising for the FDA not to require an Advisory Panel meeting however given the fact that NurOwn provides STATISTICALLY SIGNIFICANT meaningful outcomes as measured by the ALSFRS-R scale in a very important subset of patients (those with early less severe disease) pre-defined in the PIII study, it's not outside the realm of possibilities. BCLI has been able to link positive outcomes with their critical BioMarker data to reinforce NurOwn's mechanism of action which points directly to why it works best in those with early, less severe disease. All IMO