NorthWest Biotherapeutics Inc (NWBO)

[CapHillGuy]

Dan,

Thank you for providing info on FDA request for comment so I could do some searching here. I’m quite a neophyte re FDA rule making guidelines, process, timelines, and so on. Tho certainly not sure, I’ve sensed/wondered if this is relevant to tea leaves I’ve thought Doc was leaving, at least in part, as it relates to something beyond NWBO’s control vis-à-vis TLD release?

Ok, that said, I see that in this Sidley writeup, the deadline for Comments was yesterday, Nov 29, 2021. Do you or others think that these revised guidelines have a bearing on the release of TLD by NWBO ?? (And wonder if this has a bearing on CVM being in seemingly a similar quite period.).

I hope this isn’t a dumb question …

Thanks, Cap

https://www.sidley.com/en/insights/newsupdates/2021/11/fda-articulates-high-benefit-risk-expectations-for-drug-developers