Replies to post #774122 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

““this guidance focuses on the use of patient-level data from other clinical trials or from real-world data (RWD) sources, such as registries as well as electronic health records (EHRs) and medical claims.” ”

Page 1 of PDF. Clearly says “other clinical trial as well as RWD sources “

Read it to your hearts content

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products

Not sure when it will be finalized or if there will be any change to it . But there you have it .

[ATLnsider]

GPha, I’ve had Mani on Ignore for several years now. I don’t believe he will read the FDA guidance, even though I quoted the FDA guidance and I included the link to the guidance in my post.

But, just in case he wants to read the guidance, I’ll post the link again below:

https://www.fda.gov/media/171667/download