FDA requests additional Amylyx trial

[lgelb]

Summary here.

 

[Clearwater AL]

Laurie,

Last paragraph....

"Since then, The ALS Association has put out its own unusual release. Early this month, the group's
Board of Trustees affirmed their support of Balas. (Calaneet Balas) after she received "dangerous
and vulgar social media attacks"

("...after she received "dangerous and vulgar social media attacks.")

Who, what and where in the world did that come from? The big... who ? Why?

Social Media... it's getting so there's little "Social" of Social Media.

 

[lgelb]

Don't keep up with who said what there, but for anyone interested, the release (won't link to it because ALSA solicits donations on every page) is under "Stories and News" on their site.

 

[lgelb]

CENTAUR trial update video up here.

 

[lisa g]

Did I read the article in ALS News yesterday correctly? It stated that they would be enrolling 600 global individuals diagnosed 2 years or less for an 11 month phase 3 trial? Would that mean that with this phase 3 that we wouldn't be able to get access providing it proved effective for 1 1/2 to 2 years?

 

[Nikki J]

If you have not yet done so listen to the video Laurie linked but yes there is going to be a longer trial to meet the FDA and other countries’ requirements. There may be some expanded access but it won’t be enough for everyone - not even close