NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Ex, as others have said, I/we could be wrong or but maybe not. I have no problem w that. I've seen the arguments that Cognate BioServices is still involved but it seems significant to me that the recent 10K did not mention Cognate BioServices. Actually not having Cognate as a CMO doesn't concern me that much (if true). Sawston could easily pick up the slack w buildout and they'll have the experience to do it since they have the first 2 clean rooms under their belt; the tons of SOPs and Validations already created will apply to buildout too. The difference in sending a sample from someplace in the USA to Memphis or Sawston is not much since they already have shipping validation in place (one assumes). But all this talk about having worldwide capacity in place before they act got me to thinking that way when we know you just need validated manufacturing approval, be it for 500 or 5000 patients and not for 50,000 patents.

As I said not having Cognate BioServices (if true) doesn't bother me. What bothers me greatly (and may seem picayune to most) is statisticians creating data tables from the raw data. You think this would have been done before DL by the scientific personnel involved in the study and QC'd and QA'd almost concurrently. Now non-scientific types (statisticians) will have to go into the raw data and pull out data to create their tables, QC'd by them and QA'd by the Quality group or I would question the data's accuracy.

I've said my piece and hopefully won't discuss these points anymore but I just felt other than the prevalent viewpoints needed to be stated.