Nurown

[North Georgia]

Looks like they have the FDA Advisory meeting on Jan 11th.

Seems like there are two camps (pro and con) on this drug.

Best I can tell it may help some people who are not too advanced yet and have multiple
rounds of treatments.

Any opinions on this particular stem cell treatment and the likelihood / timing of
potential access ?

Thank you

 

[ace_cals]

They've presented some compelling evidence that shows the treatment has a positive effect on multiple biomarkers.

This presentation, titled "2022 ALS ONE Research Symposium: Brainstorm-Cell Therapeutics/NurOwn", with their Chief Development Officer Stacy Lindborg, PhD is a good review of their phase 3 results, including discussion around how the floor effect may have masked the efficacy of the treatment.


View: https://youtu.be/qwttt4VZbe8

From what I can tell, depending on the outcome of this meeting (ie. if the FDA decided to accept the BLA), it could be anywhere from 6 to 10 months depending on whether the FDA grants priority review to the application or not before a decision is made. I'm no expert; if others know differently please correct me!

 

[North Georgia]

Ace,

The "floor effect" you cite seems reasonable as a factor in overall lower results. Seems like the FDA should be granting approvals on safe treatments like this that can be conditional to ongoing results. I agree with your 6-10 month timeline assuming all goes well.
Thanks