Replies to post #302926 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper44,

I found a Consultation Document from 2018:
“Good Clinical Practice for Advanced Therapy Medicinal Products”

https://ec.europa.eu/health/sites/health/files/files/advtherapies/2018_gcp_atmp_en.pdf

Here is the quote from 2018:

The use of placebo should be scientifically and ethically justified. When invasive procedures are required to administer the ATMP or for the collection/extraction of the cells/tissues, control groups receiving placebo only should not be subjected to a procedure if it presents an unreasonable risk. The risk posed by the procedure should be duly explained in the protocol.

And here is the final version from October 2019:

Placebo: The use of placebo should be scientifically and ethically justified. When invasive procedures are required to administer the ATMP or for the collection/extraction of the cells/tissues, control groups receiving placebo only should not be subjected to a procedure if it presents more than minimal risk and minimal burden. The risk posed by the procedure should be duly explained in the Protocol
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/atmp_guidelines_en.pdf