BrainStorm Cell Therapeutics Inc (BCLI)

[Fmello]

- I just saw this on the No More Excuses ALS Watchdog Group Facebook page:

NUROWN Timeline = Later in 2023

Brainstorm announced it will submit a BLA to FDA's CBER

No info if Brainstorm has yet submitted the BLA

Once submitted, CBER has 60 days to decide if to accept Brainstorm's BLA for review

Brainstorm said it will only make a public announcement after FDA decides if to accept the BLA

If accepted, CBER will decide if to grant Priority Review (up to 6 months) or regular review timeline (up to 10 months).

CBER will decide if to grant an AdCom & will set a date

No PDUFA decision date but no BLA decision is possible for NurOwn until well into 2023


If Brainstorm submits the BLA before Halloween ...
And if the FDA grants Priority Review...
And if the FDA approves NurOwn...
The earliest time that NurOwn could be approved would be around June sometime.