Replies to post #774186 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Manibiotech. I have searched the entire guidance document. I don’t see the alleged quote you supposedly quoted.

Please point to the page and line number you are quoting so we can all see the context and the exact quote.

Are you referring to this part of the guidance:



If so, this does not say that patient-level data is required when a Sponsor use control group data from other clinical trials to build their ECA.

Here is the link to the FDA guidance again. Please point to the page number you are basing your opinion on:

https://www.fda.gov/media/164960/download

[manibiotech]

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

Download this draft guidance and the quote is directly from PDF pages labeled either page 1 or beginning of 2 .Draft you are referencing to don't address previous clinical trials being used as external control , but this one does . Again these are all drafts still and don't know what and when the final document will have . 

[dennisdave]

You are asking too much of ATL to actually read what Dr Liau or the FDA is saying if it doesn't fit his
$ 2000 per share fantasy hahaha