NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

I had to read your message a couple of times to appreciate what you are saying. But I get it.

For anyone who did not follow: They believe that if DCVax-L gets approval in Germany that the Germans will immediately talk to Linda Liau/Prins et al and ask for the latest and greatest recipe that is based on DCVax-L and quickly run a single arm study to allow upgrading DCVax-L to account for everything that has been learned since the long trial started. Sounds like they anticipate some faith given to the UCLA team in allowing such with a single arm trial. They were also pointing out that policies in Germany allow a lot of leeway for doctors treating patients, making all this more likely.

This in response to my saying that I thought it is possible that dropping TMZ from protocol for Mesenchymal patients might improve their outcome

(if heterogeneity does not allow non-methylated classical components to escape)

If they do end up going with biopsies up front and can confidently determine mesenchymal and (more difficult) rule out any methylated components in the mix that might respond to TMZ but are likely resistant to DCVax-L).
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Not sure about German vs EU policy at this point, it has been a while since that was in discussion. I have forgotten. I know the Germans are highly respected and their Hospital Exemption program is their own, not EU wide... so they do have some of their own policies...

All in all, I like what you are saying and hope that is the case. It would make a lot of sense to me to give the researchers that put forth a therapy to update it upon approval with minimal red-tape.