Replies to post #534623 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

werent we told this was required by the FDA?

More recently that was the supposition but early on when I began investing we were told that without a crossover option it would be hard to recruit sufficient patients and that having the option to at least belatedly get DCVax-L after recurrence if one were in the placebo group was an important inducement not to mention the humane thing to do.

I would not be surprised if a regulator required it but Dr. Liau danced around that point to avoid appearing to blame regulators for issues like confounding.

So both things could be true in that a crossover was necessary to get enough patients and regulators, due to patient interests wanted it to go that way as well.

[CrashOverride]

100B company.

[SkyLimit2022]

Yes—great post!

Exciting news in advance of SNO!

Here is a recent article from the FDA director that is highly relevant to the crossover design:

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext





https://nwbio.com/wp-content/uploads/jamaoncology_liau_2022_oi_220066_1668698380.80695.pdf

$nwbo pic.twitter.com/8hD4wfaHF1

— Blake (@MC17595091) November 15, 2022