NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Great chart and info Nick. Thanks for the link.

I agree that Project Orbis is a possibility along with other fast track designations. I'm not sure about RTOR though. Below is an article that Lyrki linked a few minutes ago and it would seem to indicate our drug is ineligible for RTOR. I'd be curious on your thoughts.

From your chart, I'd say starting at the circle and to the right could be project orbis timeline. Other fast track designations would start to the left of that circle, but prior to the red area.


Relevant quote from article Lykri linked:

Currently, the RTOR pilot is only accepting applications for supplemental indications for drugs that have already been approved by the FDA, meaning that new molecular entities (NMEs) are ineligible.

The article: https://www.zs.com/insights/pedal-to-the-metal-assessing-the-fda-s-real-time-oncology-review-program



Last post of the day. Freaking ex better not be making anymore misleading statements from my post so I don't have to wait till tomorrow to respond ;D

EDIT: Ex freaking did. Ex, my misleading ihub buddy. From your recent post:

The fact that NWBO has not yet announced they have for Fast-Track, BreakThrough Designation or RMAT should be a red flag. Why do they not yet have that when all could have been obtained years ago if there is not some undisclosed elephant?

Read my prior posts. Project Orbis for example is confidential. Not sure how you get a red flag when you are potentially keeping things confidential per the rules. Keep up the good misleading fight my friend :D

Edit Edit: Mcrae, this detail is really of minor significance and we won't know until the 2021 annual is released sometime in March/April of 2022 if they have truly gone radio silent on this topic. Sort of pointless to argue about it now.


EDit edit edit: Thanks Lyrki. Looks like RTOR has been expanded for new indications so please ignore that part of my post Nick...if you read this far.