Replies to post #772480 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

"
In the United States, oncologists may prescribe FDA-approved drugs for off-label uses under their medical discretion,"
Now try to find any kind of FDA approval of polyICLC for any indication and provide us with a link . 

[meirluc]

Thank you Chiugray for providing solid evidence that poly-ICLC has been
shown to be safe and even when administered by itself (without DCVax-L),
though not a cure, can be beneficial for many of the GBM patients.

The fact that in the accessible rGBM trial (NCT04201873), the placebo arm
consists of DCVax-L+poly-ICLC and not DCVax-L alone, is proof that the
designers of this trial knew that the combined ingredients are safe and
posses more efficacy than DCVax-L alone.

I may be wrong but my guess is that poly-ICLC will be included in the MAA
approval or will be routinely provided off label.