Panel members cite lack of pre-clinical data, and raise concerns over the higher mortality rate among the treatment group among a few other criticisms with Brainstorm's data.
Some of the data around stem cells is very interesting. It has also been quite maligned as treatment option over the decades, so I find it interesting re the renewed vigor that has dropped up i n the last 10 years.🤔🤔
It's definitely worth exploring further, however the reality of the average person being able to afford SC treatments is low at this stage. But as to this specific discussion re the FDA's stance on the use of SC in ALS, all I can say to the FDA is.....Now?! You want to start to do your actual job NOW?!
I should have added the comment that some of the remarks made by the reviewers even mentioned that all of the proposed mechanisms seem to be hypothetical rather than something substantiated by their work. I think the lack of pre-clinical data really emphasizes the point that they may not really know what's going on here. And so it all seems fascinating from a hypothetical framework, but whether it can get off the ground is another question, and I think the status of stem cell research as of now suggests that it's likely a pipe dream.
I do find it a bit ironic. I remember several of the reviewers such as Gould as being part of the Leqembi review, and so it's interesting to see what evidence some reviewers use to make their vote. I think it just shows that a lot of this is more subjective than we realize.
Great post!
That treatment should have been sponsored by the Bill and Melinda Gates Foundation - then it would pass with flying colors
Clearly, not enough money changed hands to authorise it's use.
Some of the data around stem cells is very interesting. It has also been quite maligned as treatment option over the decades, so I find it interesting re the renewed vigor that has dropped up i n the last 10 years.🤔🤔
It's definitely worth exploring further, however the reality of the average person being able to afford SC treatments is low at this stage. But as to this specific discussion re the FDA's stance on the use of SC in ALS, all I can say to the FDA is.....Now?! You want to start to do your actual job NOW?!
😐😐🤔🤨😤😤🤦♀️🤦♀️🤦♀️👏👏👏
#wearemany #wearememory #wewillnotforget #disbandtheFDA
I should have added the comment that some of the remarks made by the reviewers even mentioned that all of the proposed mechanisms seem to be hypothetical rather than something substantiated by their work. I think the lack of pre-clinical data really emphasizes the point that they may not really know what's going on here. And so it all seems fascinating from a hypothetical framework, but whether it can get off the ground is another question, and I think the status of stem cell research as of now suggests that it's likely a pipe dream.
I do find it a bit ironic. I remember several of the reviewers such as Gould as being part of the Leqembi review, and so it's interesting to see what evidence some reviewers use to make their vote. I think it just shows that a lot of this is more subjective than we realize.