Brainstorm's Expanded Access.

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KimT

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Interesting - thanks for posting this, Kim.

I'm a little confused - the article says Nurown is doing an Expanded Access Program, but then describes the eligible participants to be those that were in the just-concluded Phase 3 clinical trial. Isn't that an Open Label Extension trial, as opposed to expanded access? The statement from the CEO says he is pleased to offer the treatment to "additional patients", which confuses me even more, as it runs contrary to the description limiting it those who've just completed the Phase 3 study. Am I missing something?

I have to chuckle when they say they're offering this to "patients less severely affected by ALS", like it's possible to have a 'minor case' of ALS. I know what they mean, but I think 'slow progressor' is a better way to state it. I'm deducing they're offering it to this subgroup because that's where it showed the more significant impact.
 
It is an EAP because the treatment is being provided outside of a trial. The trial is over.

Also, they are offering the treatment to the placebo patients as well as the previously-treated patients, so thus "additional patients."
 
This will be a good thing for all of us because the longer a PALS receives it, the better idea we'll get on whether it works long term.
 
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